Cytokine, Chemokine and Growth Factor Content of Peri-implant Sulcus During Wound Healing and Osseointegration After Conventional and Piezosurgical Implant Site ... View Homepage


Ontology type: schema:MedicalStudy     


Clinical Trial Info

YEARS

2013-2015

ABSTRACT

This study aims to evaluate the levels of cytokines, chemokines and growth factors in peri-implant sulcular fluid (PISF) during healing and osseointegration at osteotomy sites prepared either with piezosurgery (PS) or drills (D). Fourteen patients having bilateral partial edentulism in the posterior maxilla were enrolled and 38 osteotomies were prepared. Implants were placed with one-stage surgery. Insertion torque, early healing index, probing depth and modified gingival and plaque indices and crestal bone (CB) loss were measured. PISF was collected from 4 sites from each implant at weeks 2, 4, 8, 12 and 24. PISF samples were analysed by a 30-Plex immunoassay. Effect of time and osteotomy method on molecules employed Brunner-Langer method. Detailed Description Surgical procedures Fourteen patients received 38 bone-level implants (4.1 mm diameter and 8 mm, 10 mm or 12 mm in length, Biodenta®, Bone Level Implant, Biodenta Swiss AG, Switzerland) Osteotomies were prepared with drills (drill group, control, n=19) on one side and with PS tips (piezosurgery group; test, n=19) on the contralateral side in a single session. Surgical, pre- and post-operative procedures were carried out as was previously described. Briefly, right side was always the first operated site where the osteotomies were prepared with one of the randomly selected methods. Toss of a coin at the beginning of the surgery by an independent examiner designated the random allocation and modality to be used on the right side of the patient. Left side received the other osteotomy modality. First a midcrestal incision was made and full-thickness flap was raised. Osteotomies were prepared in the drill group by marking the appropriate point with a trispade drill and then advancing the 2.0 mm pilot drill to the planned depth followed by 2.5 mm, 2.8 mm and 3.5 mm drills, respectively. In PS group osteotomies were prepared with PS device (Piezonmaster®, EMS SA, Switzerland) and its relevant tips (Swiss Instruments Surgery, Implant System, Switzerland). Initial tip with a 1.15 mm diameter was used along the predetermined depth to create a pilot osteotomy. Then the osteotomy was widened to a final diameter of 3.5 mm by using 1.95 mm, 2.5 mm, 2.8 mm, 3.05 mm and 3.3 mm tips, respectively. Intermediate and final diameters, depth and direction of the osteotomies were controlled in both groups with drill try-ins, which also function as paralleling pins. Bone taps or crestal drills were not used for final contouring in both groups. Then 4.1 mm-diameter implants were placed equicrestally by a handpiece at a speed of 15 rpm in both groups and insertion torque was recorded. Following transfer abutment removal, 4.0 mm diameter straight healing abutments were connected for non-submerged healing and flaps were stabilized with 5.0 polypropylene interrupted sutures. Patients were instructed to rinse with 0.2% chlorhexidine gluconate for 2 weeks and to abstain from brushing the surgery site for this period and not to chew on the healing abutments. They were prescribed 200 mg ibuprofen t.i.d for 1 week. The sutures were removed at 2nd week following the surgery. Clinical and radiological procedures A single examiner performed clinical measurements. Modified gingival (MGI) and plaque indices (MPI) were taken on weeks 2, 4, 8, 12 and 24 from 4 points around each implant with a plastic probe (UNC 12 Colorvue probe, Hu-Friedy, Chicago, IL). Probing depth (PD) was measured on weeks 12 and 24 following surgery with the same probe type (Figure 3). Repeatability of the examiner for PD measurements was κw=0.88. Flap closure and its continuity were evaluated on days 7 and 14 by early healing index (EHI), which had been originally described for postoperative monitoring of regenerative procedures for intrabony defects. Crestal bone level measurements were performed as previously described. In brief, radiographic images were obtained by cone-beam computerized tomography (CBCT) (Kodak 9000 3D, Practice Works, Inc., Atlanta, USA) on the day of surgery and at week 24. Standardized periapical radiographs were obtained at week 12 using a photostimulable phosphor plate with position holders (Rinn XCP, Dentsply International) and the long-cone paralleling technique. Images were digitalized by a photostimulable phosphor plate scanner (Digora® Optime, Soredex, USA). CB levels on radiographic images were measured with a Java-based software (Image-J 3.0, NIH, Bethesda, USA) by a masked and calibrated examiner (GPT; Cronbach's alpha=0.99). Implant shoulder (IS), first bone to implant contact (fBIC), implant abutment interface and apex of the implant were used as reference points. Mean of triple measurements rounded to the nearest 0.01 mm were used. CB loss was recorded by measuring the IS-fBIC distance on periapical radiograms at week 12 and on CBCT sections at week 24. Biochemical procedures Postoperative PISF samples were obtained from 4 aspects of implants on weeks 2, 4, 8, 12 and 24. Sites were isolated by cotton rolls and visible supramucosal plaque was removed from healing abutment surfaces with a fiber carbon curette before sampling. Following gentle air-drying, paper strips (Periopaper, ProFlow, Amityville, NY, USA) were inserted 1 mm into the crevice and left in place for 30 s. Care was taken to avoid mechanical injury. The PISF volume absorbed on each strip was then determined by means of an electronic impedance device (Periotron 8000, ProFlow, Inc., Amityville, NY, USA), and all four were pooled into a sterile polypropylene tube which was previously coded to ensure masking of the laboratory technician and kept at -40C until analysed. The readings from the Periotron 8000 were converted to volume (µl) by reference to the standard curve. The collected PISF samples were eluted in 450 µl phosphate buffer saline (PBS, pH 7.2) in the presence of EDTA-free protease inhibitor cocktail ( Roche Applied Science, Rotkreuz, Switzerland) and centrifuged at 2000 x g for 15 min, at 4C. The levels of the molecules under investigation in the eluted PISF samples were determined by the cytokine human magnetic 30-Plex panel (Novex®, ThermoFisher Scientific, Waltham, MA, USA) consisting of cytokines (G-CSF, GM-CSF, IFNα, IFNγ, IL1β, IL1RA, IL2, IL2R, IL4, IL5, IL6, IL7, IL8, IL10, IL12 (p40/p70), IL13, IL15, IL17, TNFα), chemokines (Eotaxin, CXCL10, MCP1, MIG, MIP1α, MIP1β, RANTES) and growth factors (EGF, FGF-basic, HGF, VEGF), on the Luminex®200 platform. Bead fluorescence readings were done by Luminex®200 and analyzed using a software (xPONENT®, ThermoFisher Scientific, Waltham, MA, USA). Data analysis A statistician who was blinded to the groups performed data analysis using non-parametrical methods. Implants were used as the unit of analysis. Clinical and radiological parameters served as primary outcome variables.The secondary outcome variable was selected as cytokine, chemokine and growth factor levels. Both primary and secondary outcomes were tested with Brunner and Langer method LDF2 model using a software (R software, version 3.3.1, package: nparLD, R Foundation for Statistical Computing, Vienna, Austria; r-project.org). The following hypothesis was tested: "Changes in PISF cytokine, chemokine and growth factor levels are dependent on preparation method of osteotomy (piezosurgery vs drilling) and time after surgery". Week 2 values of RANTES in study groups were compared by Mann-Whitney U test. RANTES values of groups at weeks 4, 8, 12 and 24 which were calculated as the difference from week 2 values were compared with Bonferroni corrected Mann-Whitney U test. EHI scores were compared with McNemar-Bowker chi-square test. Examiner calibration was assessed by weighted kappa and intraclass correlation coefficient methods for PD and radiological CB loss measurements, respectively with a statistical software (SPSS 20.0, SPSS for Windows, SPSS Inc., Chicago, USA). Significance level was set at 5% for all analyses. Required sample size was calculated using a software28 (G*Power 3.1, version 3.1.9.2) estimating a power of 80%, p-value of 5% in study groups for one-tailed test of matched pairs. Sample size calculation analysis suggested at least 18 implants for both groups. More... »

URL

https://clinicaltrials.gov/show/NCT03538184

Related SciGraph Publications

JSON-LD is the canonical representation for SciGraph data.

TIP: You can open this SciGraph record using an external JSON-LD service: JSON-LD Playground Google SDTT

[
  {
    "@context": "https://springernature.github.io/scigraph/jsonld/sgcontext.json", 
    "about": [
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/3053", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "type": "DefinedTerm"
      }
    ], 
    "description": "This study aims to evaluate the levels of cytokines, chemokines and growth factors in peri-implant sulcular fluid (PISF) during healing and osseointegration at osteotomy sites prepared either with piezosurgery (PS) or drills (D). Fourteen patients having bilateral partial edentulism in the posterior maxilla were enrolled and 38 osteotomies were prepared. Implants were placed with one-stage surgery. Insertion torque, early healing index, probing depth and modified gingival and plaque indices and crestal bone (CB) loss were measured. PISF was collected from 4 sites from each implant at weeks 2, 4, 8, 12 and 24. PISF samples were analysed by a 30-Plex immunoassay. Effect of time and osteotomy method on molecules employed Brunner-Langer method.\n\nDetailed Description\nSurgical procedures Fourteen patients received 38 bone-level implants (4.1 mm diameter and 8 mm, 10 mm or 12 mm in length, Biodenta\u00ae, Bone Level Implant, Biodenta Swiss AG, Switzerland) Osteotomies were prepared with drills (drill group, control, n=19) on one side and with PS tips (piezosurgery group; test, n=19) on the contralateral side in a single session. Surgical, pre- and post-operative procedures were carried out as was previously described. Briefly, right side was always the first operated site where the osteotomies were prepared with one of the randomly selected methods. Toss of a coin at the beginning of the surgery by an independent examiner designated the random allocation and modality to be used on the right side of the patient. Left side received the other osteotomy modality. First a midcrestal incision was made and full-thickness flap was raised. Osteotomies were prepared in the drill group by marking the appropriate point with a trispade drill and then advancing the 2.0 mm pilot drill to the planned depth followed by 2.5 mm, 2.8 mm and 3.5 mm drills, respectively. In PS group osteotomies were prepared with PS device (Piezonmaster\u00ae, EMS SA, Switzerland) and its relevant tips (Swiss Instruments Surgery, Implant System, Switzerland). Initial tip with a 1.15 mm diameter was used along the predetermined depth to create a pilot osteotomy. Then the osteotomy was widened to a final diameter of 3.5 mm by using 1.95 mm, 2.5 mm, 2.8 mm, 3.05 mm and 3.3 mm tips, respectively. Intermediate and final diameters, depth and direction of the osteotomies were controlled in both groups with drill try-ins, which also function as paralleling pins. Bone taps or crestal drills were not used for final contouring in both groups. Then 4.1 mm-diameter implants were placed equicrestally by a handpiece at a speed of 15 rpm in both groups and insertion torque was recorded. Following transfer abutment removal, 4.0 mm diameter straight healing abutments were connected for non-submerged healing and flaps were stabilized with 5.0 polypropylene interrupted sutures. Patients were instructed to rinse with 0.2% chlorhexidine gluconate for 2 weeks and to abstain from brushing the surgery site for this period and not to chew on the healing abutments. They were prescribed 200 mg ibuprofen t.i.d for 1 week. The sutures were removed at 2nd week following the surgery. Clinical and radiological procedures A single examiner performed clinical measurements. Modified gingival (MGI) and plaque indices (MPI) were taken on weeks 2, 4, 8, 12 and 24 from 4 points around each implant with a plastic probe (UNC 12 Colorvue probe, Hu-Friedy, Chicago, IL). Probing depth (PD) was measured on weeks 12 and 24 following surgery with the same probe type (Figure 3). Repeatability of the examiner for PD measurements was \u03baw=0.88. Flap closure and its continuity were evaluated on days 7 and 14 by early healing index (EHI), which had been originally described for postoperative monitoring of regenerative procedures for intrabony defects. Crestal bone level measurements were performed as previously described. In brief, radiographic images were obtained by cone-beam computerized tomography (CBCT) (Kodak 9000 3D, Practice Works, Inc., Atlanta, USA) on the day of surgery and at week 24. Standardized periapical radiographs were obtained at week 12 using a photostimulable phosphor plate with position holders (Rinn XCP, Dentsply International) and the long-cone paralleling technique. Images were digitalized by a photostimulable phosphor plate scanner (Digora\u00ae Optime, Soredex, USA). CB levels on radiographic images were measured with a Java-based software (Image-J 3.0, NIH, Bethesda, USA) by a masked and calibrated examiner (GPT; Cronbach's alpha=0.99). Implant shoulder (IS), first bone to implant contact (fBIC), implant abutment interface and apex of the implant were used as reference points. Mean of triple measurements rounded to the nearest 0.01 mm were used. CB loss was recorded by measuring the IS-fBIC distance on periapical radiograms at week 12 and on CBCT sections at week 24. Biochemical procedures Postoperative PISF samples were obtained from 4 aspects of implants on weeks 2, 4, 8, 12 and 24. Sites were isolated by cotton rolls and visible supramucosal plaque was removed from healing abutment surfaces with a fiber carbon curette before sampling. Following gentle air-drying, paper strips (Periopaper, ProFlow, Amityville, NY, USA) were inserted 1 mm into the crevice and left in place for 30 s. Care was taken to avoid mechanical injury. The PISF volume absorbed on each strip was then determined by means of an electronic impedance device (Periotron 8000, ProFlow, Inc., Amityville, NY, USA), and all four were pooled into a sterile polypropylene tube which was previously coded to ensure masking of the laboratory technician and kept at -40C until analysed. The readings from the Periotron 8000 were converted to volume (\u00b5l) by reference to the standard curve. The collected PISF samples were eluted in 450 \u00b5l phosphate buffer saline (PBS, pH 7.2) in the presence of EDTA-free protease inhibitor cocktail ( Roche Applied Science, Rotkreuz, Switzerland) and centrifuged at 2000 x g for 15 min, at 4C. The levels of the molecules under investigation in the eluted PISF samples were determined by the cytokine human magnetic 30-Plex panel (Novex\u00ae, ThermoFisher Scientific, Waltham, MA, USA) consisting of cytokines (G-CSF, GM-CSF, IFN\u03b1, IFN\u03b3, IL1\u03b2, IL1RA, IL2, IL2R, IL4, IL5, IL6, IL7, IL8, IL10, IL12 (p40/p70), IL13, IL15, IL17, TNF\u03b1), chemokines (Eotaxin, CXCL10, MCP1, MIG, MIP1\u03b1, MIP1\u03b2, RANTES) and growth factors (EGF, FGF-basic, HGF, VEGF), on the Luminex\u00ae200 platform. Bead fluorescence readings were done by Luminex\u00ae200 and analyzed using a software (xPONENT\u00ae, ThermoFisher Scientific, Waltham, MA, USA). Data analysis A statistician who was blinded to the groups performed data analysis using non-parametrical methods. Implants were used as the unit of analysis. Clinical and radiological parameters served as primary outcome variables.The secondary outcome variable was selected as cytokine, chemokine and growth factor levels. Both primary and secondary outcomes were tested with Brunner and Langer method LDF2 model using a software (R software, version 3.3.1, package: nparLD, R Foundation for Statistical Computing, Vienna, Austria; r-project.org). The following hypothesis was tested: \"Changes in PISF cytokine, chemokine and growth factor levels are dependent on preparation method of osteotomy (piezosurgery vs drilling) and time after surgery\". Week 2 values of RANTES in study groups were compared by Mann-Whitney U test. RANTES values of groups at weeks 4, 8, 12 and 24 which were calculated as the difference from week 2 values were compared with Bonferroni corrected Mann-Whitney U test. EHI scores were compared with McNemar-Bowker chi-square test. Examiner calibration was assessed by weighted kappa and intraclass correlation coefficient methods for PD and radiological CB loss measurements, respectively with a statistical software (SPSS 20.0, SPSS for Windows, SPSS Inc., Chicago, USA). Significance level was set at 5% for all analyses. Required sample size was calculated using a software28 (G*Power 3.1, version 3.1.9.2) estimating a power of 80%, p-value of 5% in study groups for one-tailed test of matched pairs. Sample size calculation analysis suggested at least 18 implants for both groups.", 
    "endDate": "2015-04-01T00:00:00Z", 
    "id": "sg:clinicaltrial.NCT03538184", 
    "keywords": [
      "cytokine", 
      "growth factor", 
      "wound healing", 
      "osseointegration", 
      "site preparation", 
      "chemokines", 
      "implant", 
      "healing", 
      "PS", 
      "Mandrillus", 
      "patient", 
      "posterior", 
      "stage", 
      "insertion", 
      "depth", 
      "plaque", 
      "fluid sample", 
      "immunoassay", 
      "method", 
      "molecule", 
      "surgical procedure", 
      "mm diameter", 
      "mm", 
      "Ag", 
      "Switzerland", 
      "control", 
      "tip", 
      "single session", 
      "toss", 
      "Numismatics", 
      "beginning", 
      "General Surgery", 
      "examiner", 
      "Random Allocation", 
      "modality", 
      "left", 
      "incision", 
      "full thickness", 
      "appropriate point", 
      "pilot", 
      "p-groups", 
      "EM", 
      "instrument", 
      "diameter", 
      "intermediate", 
      "IN", 
      "pin", 
      "TAP", 
      "rpm", 
      "transfer", 
      "flap", 
      "polypropylene", 
      "rinse", 
      "chlorhexidine gluconate", 
      "abstain", 
      "brushing", 
      "period", 
      "abutment", 
      "ibuprofen", 
      "suture", 
      "clinical measurement", 
      "plastic", 
      "probe", 
      "HU", 
      "Chicago", 
      "IL", 
      "Probing", 
      "same probe", 
      "repeatability", 
      "measurement", 
      "closure", 
      "continuity", 
      "defect", 
      "radiographic image", 
      "Cone-Beam Computed Tomography", 
      "Kodak", 
      "practice", 
      "Inc.", 
      "Atlanta", 
      "USA", 
      "radiograph", 
      "phosphor", 
      "holder", 
      "International", 
      "technique", 
      "software", 
      "NIH", 
      "Bethesda", 
      "Cronbach's", 
      "shoulder", 
      "bone implant", 
      "interface", 
      "apex", 
      "reference point", 
      "mean", 
      "bone loss", 
      "computerized tomography", 
      "biochemical procedure", 
      "aspect", 
      "cotton", 
      "carbon", 
      "sampling", 
      "drying", 
      "paper", 
      "NY", 
      "crevice", 
      "care", 
      "mechanical injury", 
      "fluid volume", 
      "strip", 
      "electronics", 
      "Laboratory Personnel", 
      "reading", 
      "volume", 
      "reference", 
      "standard curve", 
      "phosphate", 
      "Hydrogen-Ion Concentration", 
      "protease inhibitor", 
      "applied science", 
      "min", 
      "Waltham", 
      "MA", 
      "Granulocyte Colony-Stimulating Factor", 
      "Granulocyte-Macrophage Colony-Stimulating Factor", 
      "Interleukin-2", 
      "IL2R", 
      "Interleukin-4", 
      "Interleukin-5", 
      "Interleukin-6", 
      "Interleukin-7", 
      "Interleukin-8", 
      "Interleukin-10", 
      "Interleukin-12", 
      "Interleukin-13", 
      "Interleukin-15", 
      "IL17", 
      "eotaxin", 
      "CXCL10", 
      "mIg", 
      "epidermal growth factor", 
      "HGF", 
      "Vascular Endothelial Growth Factor A", 
      "platform", 
      "fluorescence", 
      "Statistic as Topic", 
      "statistician", 
      "unit", 
      "parameter", 
      "primary outcome variable", 
      "Secondary outcome", 
      "growth factor level", 
      "primary and secondary outcome", 
      "version", 
      "package", 
      "foundation", 
      "Vienna", 
      "Austria", 
      "preparation method", 
      "drilling", 
      "Chemokine CCL5", 
      "study group", 
      "difference", 
      "chi-square", 
      "calibration", 
      "kappa", 
      "intraclass correlation coefficient", 
      "statistical software", 
      "SPSS", 
      "window", 
      "significance level", 
      "required sample size", 
      "power", 
      "p-values", 
      "pair", 
      "sample size calculation"
    ], 
    "name": "Cytokine, Chemokine and Growth Factor Content of Peri-implant Sulcus During Wound Healing and Osseointegration After Conventional and Piezosurgical Implant Site Preparation", 
    "sameAs": [
      "https://app.dimensions.ai/details/clinical_trial/NCT03538184"
    ], 
    "sdDataset": "clinical_trials", 
    "sdDatePublished": "2019-03-07T15:27", 
    "sdLicense": "https://scigraph.springernature.com/explorer/license/", 
    "sdPublisher": {
      "name": "Springer Nature - SN SciGraph project", 
      "type": "Organization"
    }, 
    "sdSource": "file:///pack/app/us_ct_data_00027.json", 
    "sponsor": [
      {
        "id": "https://www.grid.ac/institutes/grid.8302.9", 
        "type": "Organization"
      }
    ], 
    "startDate": "2013-05-01T00:00:00Z", 
    "subjectOf": [
      {
        "id": "https://doi.org/10.1111/clr.12620", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1006789644"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1097/id.0000000000000463", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1011073628"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1111/jcpe.12206", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1019113816"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1111/jcpe.12591", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1026317222"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1111/jcpe.12127", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1040470599"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1186/1479-5876-11-221", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1050439113", 
          "https://doi.org/10.1186/1479-5876-11-221"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1034/j.1600-0501.2003.00972.x", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1051940950"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1111/j.1600-0501.2006.01380.x", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1052805550"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1111/clr.12223", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1053311327"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1902/jop.2007.060285", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1068735996"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1002/jbm.a.36060", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1084012812"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s00784-017-2169-0", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1090675405", 
          "https://doi.org/10.1007/s00784-017-2169-0"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s00784-017-2169-0", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1090675405", 
          "https://doi.org/10.1007/s00784-017-2169-0"
        ], 
        "type": "CreativeWork"
      }
    ], 
    "type": "MedicalStudy", 
    "url": "https://clinicaltrials.gov/show/NCT03538184"
  }
]
 

Download the RDF metadata as:  json-ld nt turtle xml License info

HOW TO GET THIS DATA PROGRAMMATICALLY:

JSON-LD is a popular format for linked data which is fully compatible with JSON.

curl -H 'Accept: application/ld+json' 'https://scigraph.springernature.com/clinicaltrial.NCT03538184'

N-Triples is a line-based linked data format ideal for batch operations.

curl -H 'Accept: application/n-triples' 'https://scigraph.springernature.com/clinicaltrial.NCT03538184'

Turtle is a human-readable linked data format.

curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/clinicaltrial.NCT03538184'

RDF/XML is a standard XML format for linked data.

curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/clinicaltrial.NCT03538184'


 

This table displays all metadata directly associated to this object as RDF triples.

233 TRIPLES      16 PREDICATES      203 URIs      185 LITERALS      1 BLANK NODES

Subject Predicate Object
1 sg:clinicaltrial.NCT03538184 schema:about anzsrc-for:3053
2 schema:description This study aims to evaluate the levels of cytokines, chemokines and growth factors in peri-implant sulcular fluid (PISF) during healing and osseointegration at osteotomy sites prepared either with piezosurgery (PS) or drills (D). Fourteen patients having bilateral partial edentulism in the posterior maxilla were enrolled and 38 osteotomies were prepared. Implants were placed with one-stage surgery. Insertion torque, early healing index, probing depth and modified gingival and plaque indices and crestal bone (CB) loss were measured. PISF was collected from 4 sites from each implant at weeks 2, 4, 8, 12 and 24. PISF samples were analysed by a 30-Plex immunoassay. Effect of time and osteotomy method on molecules employed Brunner-Langer method. Detailed Description Surgical procedures Fourteen patients received 38 bone-level implants (4.1 mm diameter and 8 mm, 10 mm or 12 mm in length, Biodenta®, Bone Level Implant, Biodenta Swiss AG, Switzerland) Osteotomies were prepared with drills (drill group, control, n=19) on one side and with PS tips (piezosurgery group; test, n=19) on the contralateral side in a single session. Surgical, pre- and post-operative procedures were carried out as was previously described. Briefly, right side was always the first operated site where the osteotomies were prepared with one of the randomly selected methods. Toss of a coin at the beginning of the surgery by an independent examiner designated the random allocation and modality to be used on the right side of the patient. Left side received the other osteotomy modality. First a midcrestal incision was made and full-thickness flap was raised. Osteotomies were prepared in the drill group by marking the appropriate point with a trispade drill and then advancing the 2.0 mm pilot drill to the planned depth followed by 2.5 mm, 2.8 mm and 3.5 mm drills, respectively. In PS group osteotomies were prepared with PS device (Piezonmaster®, EMS SA, Switzerland) and its relevant tips (Swiss Instruments Surgery, Implant System, Switzerland). Initial tip with a 1.15 mm diameter was used along the predetermined depth to create a pilot osteotomy. Then the osteotomy was widened to a final diameter of 3.5 mm by using 1.95 mm, 2.5 mm, 2.8 mm, 3.05 mm and 3.3 mm tips, respectively. Intermediate and final diameters, depth and direction of the osteotomies were controlled in both groups with drill try-ins, which also function as paralleling pins. Bone taps or crestal drills were not used for final contouring in both groups. Then 4.1 mm-diameter implants were placed equicrestally by a handpiece at a speed of 15 rpm in both groups and insertion torque was recorded. Following transfer abutment removal, 4.0 mm diameter straight healing abutments were connected for non-submerged healing and flaps were stabilized with 5.0 polypropylene interrupted sutures. Patients were instructed to rinse with 0.2% chlorhexidine gluconate for 2 weeks and to abstain from brushing the surgery site for this period and not to chew on the healing abutments. They were prescribed 200 mg ibuprofen t.i.d for 1 week. The sutures were removed at 2nd week following the surgery. Clinical and radiological procedures A single examiner performed clinical measurements. Modified gingival (MGI) and plaque indices (MPI) were taken on weeks 2, 4, 8, 12 and 24 from 4 points around each implant with a plastic probe (UNC 12 Colorvue probe, Hu-Friedy, Chicago, IL). Probing depth (PD) was measured on weeks 12 and 24 following surgery with the same probe type (Figure 3). Repeatability of the examiner for PD measurements was κw=0.88. Flap closure and its continuity were evaluated on days 7 and 14 by early healing index (EHI), which had been originally described for postoperative monitoring of regenerative procedures for intrabony defects. Crestal bone level measurements were performed as previously described. In brief, radiographic images were obtained by cone-beam computerized tomography (CBCT) (Kodak 9000 3D, Practice Works, Inc., Atlanta, USA) on the day of surgery and at week 24. Standardized periapical radiographs were obtained at week 12 using a photostimulable phosphor plate with position holders (Rinn XCP, Dentsply International) and the long-cone paralleling technique. Images were digitalized by a photostimulable phosphor plate scanner (Digora® Optime, Soredex, USA). CB levels on radiographic images were measured with a Java-based software (Image-J 3.0, NIH, Bethesda, USA) by a masked and calibrated examiner (GPT; Cronbach's alpha=0.99). Implant shoulder (IS), first bone to implant contact (fBIC), implant abutment interface and apex of the implant were used as reference points. Mean of triple measurements rounded to the nearest 0.01 mm were used. CB loss was recorded by measuring the IS-fBIC distance on periapical radiograms at week 12 and on CBCT sections at week 24. Biochemical procedures Postoperative PISF samples were obtained from 4 aspects of implants on weeks 2, 4, 8, 12 and 24. Sites were isolated by cotton rolls and visible supramucosal plaque was removed from healing abutment surfaces with a fiber carbon curette before sampling. Following gentle air-drying, paper strips (Periopaper, ProFlow, Amityville, NY, USA) were inserted 1 mm into the crevice and left in place for 30 s. Care was taken to avoid mechanical injury. The PISF volume absorbed on each strip was then determined by means of an electronic impedance device (Periotron 8000, ProFlow, Inc., Amityville, NY, USA), and all four were pooled into a sterile polypropylene tube which was previously coded to ensure masking of the laboratory technician and kept at -40C until analysed. The readings from the Periotron 8000 were converted to volume (µl) by reference to the standard curve. The collected PISF samples were eluted in 450 µl phosphate buffer saline (PBS, pH 7.2) in the presence of EDTA-free protease inhibitor cocktail ( Roche Applied Science, Rotkreuz, Switzerland) and centrifuged at 2000 x g for 15 min, at 4C. The levels of the molecules under investigation in the eluted PISF samples were determined by the cytokine human magnetic 30-Plex panel (Novex®, ThermoFisher Scientific, Waltham, MA, USA) consisting of cytokines (G-CSF, GM-CSF, IFNα, IFNγ, IL1β, IL1RA, IL2, IL2R, IL4, IL5, IL6, IL7, IL8, IL10, IL12 (p40/p70), IL13, IL15, IL17, TNFα), chemokines (Eotaxin, CXCL10, MCP1, MIG, MIP1α, MIP1β, RANTES) and growth factors (EGF, FGF-basic, HGF, VEGF), on the Luminex®200 platform. Bead fluorescence readings were done by Luminex®200 and analyzed using a software (xPONENT®, ThermoFisher Scientific, Waltham, MA, USA). Data analysis A statistician who was blinded to the groups performed data analysis using non-parametrical methods. Implants were used as the unit of analysis. Clinical and radiological parameters served as primary outcome variables.The secondary outcome variable was selected as cytokine, chemokine and growth factor levels. Both primary and secondary outcomes were tested with Brunner and Langer method LDF2 model using a software (R software, version 3.3.1, package: nparLD, R Foundation for Statistical Computing, Vienna, Austria; r-project.org). The following hypothesis was tested: "Changes in PISF cytokine, chemokine and growth factor levels are dependent on preparation method of osteotomy (piezosurgery vs drilling) and time after surgery". Week 2 values of RANTES in study groups were compared by Mann-Whitney U test. RANTES values of groups at weeks 4, 8, 12 and 24 which were calculated as the difference from week 2 values were compared with Bonferroni corrected Mann-Whitney U test. EHI scores were compared with McNemar-Bowker chi-square test. Examiner calibration was assessed by weighted kappa and intraclass correlation coefficient methods for PD and radiological CB loss measurements, respectively with a statistical software (SPSS 20.0, SPSS for Windows, SPSS Inc., Chicago, USA). Significance level was set at 5% for all analyses. Required sample size was calculated using a software28 (G*Power 3.1, version 3.1.9.2) estimating a power of 80%, p-value of 5% in study groups for one-tailed test of matched pairs. Sample size calculation analysis suggested at least 18 implants for both groups.
3 schema:endDate 2015-04-01T00:00:00Z
4 schema:keywords Ag
5 Atlanta
6 Austria
7 Bethesda
8 CXCL10
9 Chemokine CCL5
10 Chicago
11 Cone-Beam Computed Tomography
12 Cronbach's
13 EM
14 General Surgery
15 Granulocyte Colony-Stimulating Factor
16 Granulocyte-Macrophage Colony-Stimulating Factor
17 HGF
18 HU
19 Hydrogen-Ion Concentration
20 IL
21 IL17
22 IL2R
23 IN
24 Inc.
25 Interleukin-10
26 Interleukin-12
27 Interleukin-13
28 Interleukin-15
29 Interleukin-2
30 Interleukin-4
31 Interleukin-5
32 Interleukin-6
33 Interleukin-7
34 Interleukin-8
35 International
36 Kodak
37 Laboratory Personnel
38 MA
39 Mandrillus
40 NIH
41 NY
42 Numismatics
43 PS
44 Probing
45 Random Allocation
46 SPSS
47 Secondary outcome
48 Statistic as Topic
49 Switzerland
50 TAP
51 USA
52 Vascular Endothelial Growth Factor A
53 Vienna
54 Waltham
55 abstain
56 abutment
57 apex
58 applied science
59 appropriate point
60 aspect
61 beginning
62 biochemical procedure
63 bone implant
64 bone loss
65 brushing
66 calibration
67 carbon
68 care
69 chemokines
70 chi-square
71 chlorhexidine gluconate
72 clinical measurement
73 closure
74 computerized tomography
75 continuity
76 control
77 cotton
78 crevice
79 cytokine
80 defect
81 depth
82 diameter
83 difference
84 drilling
85 drying
86 electronics
87 eotaxin
88 epidermal growth factor
89 examiner
90 flap
91 fluid sample
92 fluid volume
93 fluorescence
94 foundation
95 full thickness
96 growth factor
97 growth factor level
98 healing
99 holder
100 ibuprofen
101 immunoassay
102 implant
103 incision
104 insertion
105 instrument
106 interface
107 intermediate
108 intraclass correlation coefficient
109 kappa
110 left
111 mIg
112 mean
113 measurement
114 mechanical injury
115 method
116 min
117 mm
118 mm diameter
119 modality
120 molecule
121 osseointegration
122 p-groups
123 p-values
124 package
125 pair
126 paper
127 parameter
128 patient
129 period
130 phosphate
131 phosphor
132 pilot
133 pin
134 plaque
135 plastic
136 platform
137 polypropylene
138 posterior
139 power
140 practice
141 preparation method
142 primary and secondary outcome
143 primary outcome variable
144 probe
145 protease inhibitor
146 radiograph
147 radiographic image
148 reading
149 reference
150 reference point
151 repeatability
152 required sample size
153 rinse
154 rpm
155 same probe
156 sample size calculation
157 sampling
158 shoulder
159 significance level
160 single session
161 site preparation
162 software
163 stage
164 standard curve
165 statistical software
166 statistician
167 strip
168 study group
169 surgical procedure
170 suture
171 technique
172 tip
173 toss
174 transfer
175 unit
176 version
177 volume
178 window
179 wound healing
180 schema:name Cytokine, Chemokine and Growth Factor Content of Peri-implant Sulcus During Wound Healing and Osseointegration After Conventional and Piezosurgical Implant Site Preparation
181 schema:sameAs https://app.dimensions.ai/details/clinical_trial/NCT03538184
182 schema:sdDatePublished 2019-03-07T15:27
183 schema:sdLicense https://scigraph.springernature.com/explorer/license/
184 schema:sdPublisher N81ad8689fe584e24a657b659aed6367a
185 schema:sponsor https://www.grid.ac/institutes/grid.8302.9
186 schema:startDate 2013-05-01T00:00:00Z
187 schema:subjectOf sg:pub.10.1007/s00784-017-2169-0
188 sg:pub.10.1186/1479-5876-11-221
189 https://doi.org/10.1002/jbm.a.36060
190 https://doi.org/10.1034/j.1600-0501.2003.00972.x
191 https://doi.org/10.1097/id.0000000000000463
192 https://doi.org/10.1111/clr.12223
193 https://doi.org/10.1111/clr.12620
194 https://doi.org/10.1111/j.1600-0501.2006.01380.x
195 https://doi.org/10.1111/jcpe.12127
196 https://doi.org/10.1111/jcpe.12206
197 https://doi.org/10.1111/jcpe.12591
198 https://doi.org/10.1902/jop.2007.060285
199 schema:url https://clinicaltrials.gov/show/NCT03538184
200 sgo:license sg:explorer/license/
201 sgo:sdDataset clinical_trials
202 rdf:type schema:MedicalStudy
203 N81ad8689fe584e24a657b659aed6367a schema:name Springer Nature - SN SciGraph project
204 rdf:type schema:Organization
205 anzsrc-for:3053 schema:inDefinedTermSet anzsrc-for:
206 rdf:type schema:DefinedTerm
207 sg:pub.10.1007/s00784-017-2169-0 schema:sameAs https://app.dimensions.ai/details/publication/pub.1090675405
208 https://doi.org/10.1007/s00784-017-2169-0
209 rdf:type schema:CreativeWork
210 sg:pub.10.1186/1479-5876-11-221 schema:sameAs https://app.dimensions.ai/details/publication/pub.1050439113
211 https://doi.org/10.1186/1479-5876-11-221
212 rdf:type schema:CreativeWork
213 https://doi.org/10.1002/jbm.a.36060 schema:sameAs https://app.dimensions.ai/details/publication/pub.1084012812
214 rdf:type schema:CreativeWork
215 https://doi.org/10.1034/j.1600-0501.2003.00972.x schema:sameAs https://app.dimensions.ai/details/publication/pub.1051940950
216 rdf:type schema:CreativeWork
217 https://doi.org/10.1097/id.0000000000000463 schema:sameAs https://app.dimensions.ai/details/publication/pub.1011073628
218 rdf:type schema:CreativeWork
219 https://doi.org/10.1111/clr.12223 schema:sameAs https://app.dimensions.ai/details/publication/pub.1053311327
220 rdf:type schema:CreativeWork
221 https://doi.org/10.1111/clr.12620 schema:sameAs https://app.dimensions.ai/details/publication/pub.1006789644
222 rdf:type schema:CreativeWork
223 https://doi.org/10.1111/j.1600-0501.2006.01380.x schema:sameAs https://app.dimensions.ai/details/publication/pub.1052805550
224 rdf:type schema:CreativeWork
225 https://doi.org/10.1111/jcpe.12127 schema:sameAs https://app.dimensions.ai/details/publication/pub.1040470599
226 rdf:type schema:CreativeWork
227 https://doi.org/10.1111/jcpe.12206 schema:sameAs https://app.dimensions.ai/details/publication/pub.1019113816
228 rdf:type schema:CreativeWork
229 https://doi.org/10.1111/jcpe.12591 schema:sameAs https://app.dimensions.ai/details/publication/pub.1026317222
230 rdf:type schema:CreativeWork
231 https://doi.org/10.1902/jop.2007.060285 schema:sameAs https://app.dimensions.ai/details/publication/pub.1068735996
232 rdf:type schema:CreativeWork
233 https://www.grid.ac/institutes/grid.8302.9 schema:Organization
 




Preview window. Press ESC to close (or click here)


...