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Molecular Content of Peri-implant Sulcus During Wound Healing and Osseointegration Following Drilling and Piezosurgery

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ClinicalTrials.gov Identifier: NCT03538184
Recruitment Status : Completed
First Posted : May 29, 2018
Last Update Posted : May 29, 2018
Sponsor:
Information provided by (Responsible Party):
Gözde Peker Tekdal, Ege University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tooth Loss Edentulous Jaw Procedure: Piezosurgery Procedure: Drill Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cytokine, Chemokine and Growth Factor Content of Peri-implant Sulcus During Wound Healing and Osseointegration After Conventional and Piezosurgical Implant Site Preparation
Actual Study Start Date : May 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : April 2015

Arm Intervention/treatment
Experimental: Piezosurgery
Osteotomy preparation entirely with piezosurgery tips and equicrestal placement of a 4.1 mm implant in the piezosurgery (test) group were performed as follows: 1.15 mm initial MB1 tip, 1.95 mm MB2 tip, control of depth, diameter and direction of osteotomy with 2.0 mm paralleling pin, 2.5 mm MB3 tip, 2.8 mm MB4 tip, 2.8 mm paralleling pin, 3.05 mm MB5 tip, 3.3 mm MB6 tip, control of final diameter of the osteotomy with 3.5 mm paralleling pin, placement of the 4.1 mm diameter implant and connection of a 4 mm-wide healing abutment.
Procedure: Piezosurgery
Preparation of implant beds entirely with piezo surgery implant tips

Active Comparator: Drill
Preparation of an implant recipient site entirely with relevant drills were performed as follows: Osteotomy preparation and equicrestal placement of a 4.1 mm diameter implant in the drill (control) group were performed as follows: initial trispade drill, 2.0 mm pilot drill, control of depth, diameter and direction of osteotomy with 2.0 mm paralleling pin, 2.5 mm drill, 2.8 mm drill, 2.8 mm paralleling pin, 3.5 mm drill, control of final diameter of the osteotomy with 3.5 mm paralleling pin, placement of the 4.1 mm diameter implant and connection of a 4 mm wide healing abutment.
Procedure: Drill
Preparation of implant beds entirely with conventional implant drills




Primary Outcome Measures :
  1. Radiological bone levels at 12th and 24th weeks (Change from Baseline) [ Time Frame: Baseline (implant placement), 12th and 24th weeks after implant placement ]
    Bone Loss (measured distance from implant shoulder to first bone to implant contact on periodical radiographs and computerised cone beam tomography


Secondary Outcome Measures :
  1. IL-1beta content of peri implant sulcus fluid at 4th, 8th, 12th and 24th weeks (Change from 2nd week) [ Time Frame: 2nd,4th, 8th, 12th and 24th weeks ]
    cytokine

  2. G.CSF content of peri implant sulcus fluid at 4th, 8th, 12th and 24th weeks (Change from 2nd week) [ Time Frame: 2nd,4th, 8th, 12th and 24th weeks ]
    cytokine

  3. IL-13 content of peri implant sulcus fluid at 4th, 8th, 12th and 24th weeks (Change from 2nd week) [ Time Frame: 2nd,4th, 8th, 12th and 24th weeks ]
    cytokine

  4. IL-6 content of peri implant sulcus fluid at 4th, 8th, 12th and 24th weeks (Change from 2nd week) [ Time Frame: 2nd,4th, 8th, 12th and 24th weeks ]
    cytokine

  5. IL-12 content of peri implant sulcus fluid at 4th, 8th, 12th and 24th weeks (Change from 2nd week) [ Time Frame: 2nd,4th, 8th, 12th and 24th weeks ]
    cytokine

  6. IL-17 content of peri implant sulcus fluid at 4th, 8th, 12th and 24th weeks (Change from 2nd week [ Time Frame: 2nd,4th, 8th, 12th and 24th weeks ]
    cytokine

  7. IL-15 content of peri implant sulcus fluid at 4th, 8th, 12th and 24th weeks (Change from 2nd week [ Time Frame: 2nd,4th, 8th, 12th and 24th weeks ]
    cytokine

  8. IL-5 content of peri implant sulcus fluid at 4th, 8th, 12th and 24th weeks (Change from 2nd week) [ Time Frame: 2nd,4th, 8th, 12th and 24th weeks ]
    cytokine

  9. IFN gamma content of peri implant sulcus fluid at 4th, 8th, 12th and 24th weeks (Change from 2nd week) [ Time Frame: 2nd,4th, 8th, 12th and 24th weeks ]
    cytokine

  10. IFN alpha content of peri implant sulcus fluid at 4th, 8th, 12th and 24th weeks (Change from 2nd week) [ Time Frame: 2nd,4th, 8th, 12th and 24th weeks ]
    cytokine

  11. IL-1Ra alpha content of peri implant sulcus fluid at 4th, 8th, 12th and 24th weeks (Change from 2nd week) [ Time Frame: 2nd,4th, 8th, 12th and 24th weeks ]
    cytokine

  12. IL-2 alpha content of peri implant sulcus fluid at 4th, 8th, 12th and 24th weeks (Change from 2nd week) [ Time Frame: 2nd,4th, 8th, 12th and 24th weeks ]
    cytokine

  13. IL-7 alpha content of peri implant sulcus fluid at 4th, 8th, 12th and 24th weeks (Change from 2nd week) [ Time Frame: 2nd,4th, 8th, 12th and 24th weeks ]
    cytokine

  14. IL-2R alpha content of peri implant sulcus fluid at 4th, 8th, 12th and 24th weeks (Change from 2nd week) [ Time Frame: 2nd,4th, 8th, 12th and 24th weeks ]
    cytokine

  15. IL-4 alpha content of peri implant sulcus fluid at 4th, 8th, 12th and 24th weeks (Change from 2nd week) [ Time Frame: 2nd,4th, 8th, 12th and 24th weeks ]
    cytokine

  16. IL-8 alpha content of peri implant sulcus fluid at 4th, 8th, 12th and 24th weeks (Change from 2nd week) [ Time Frame: 2nd,4th, 8th, 12th and 24th weeks ]
    cytokine

  17. RANTES alpha content of peri implant sulcus fluid at 4th, 8th, 12th and 24th weeks (Change from 2nd week) [ Time Frame: 2nd,4th, 8th, 12th and 24th weeks ]
    chemokine

  18. MIP-1alpha alpha content of peri implant sulcus fluid at 4th, 8th, 12th and 24th weeks (Change from 2nd week) [ Time Frame: 2nd,4th, 8th, 12th and 24th weeks ]
    chemokine

  19. MIP-1beta alpha content of peri implant sulcus fluid at 4th, 8th, 12th and 24th weeks (Change from 2nd week) [ Time Frame: 2nd,4th, 8th, 12th and 24th weeks ]
    chemokine

  20. MCP-1 alpha content of peri implant sulcus fluid at 4th, 8th, 12th and 24th weeks (Change from 2nd week) [ Time Frame: 2nd,4th, 8th, 12th and 24th weeks ]
    chemokine

  21. MIG content of peri implant sulcus fluid at 4th, 8th, 12th and 24th weeks (Change from 2nd week) [ Time Frame: 2nd,4th, 8th, 12th and 24th weeks ]
    chemokine

  22. IP-10 content of peri implant sulcus fluid at 4th, 8th, 12th and 24th weeks (Change from 2nd week) [ Time Frame: 2nd,4th, 8th, 12th and 24th weeks ]
    chemokine

  23. FGF-b content of peri implant sulcus fluid at 4th, 8th, 12th and 24th weeks (Change from 2nd week) [ Time Frame: 2nd,4th, 8th, 12th and 24th weeks ]
    growth factor

  24. EGF content of peri implant sulcus fluid at 4th, 8th, 12th and 24th weeks (Change from 2nd week) [ Time Frame: 2nd,4th, 8th, 12th and 24th weeks ]
    growth factor

  25. HGF content of peri implant sulcus fluid at 4th, 8th, 12th and 24th weeks (Change from 2nd week) [ Time Frame: 2nd,4th, 8th, 12th and 24th weeks ]
    growth factor

  26. VEGF content of peri implant sulcus fluid at 4th, 8th, 12th and 24th weeks (Change from 2nd week) [ Time Frame: 2nd,4th, 8th, 12th and 24th weeks ]
    growth factor



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Ages Eligible for Study:   31 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Bilateral partial edentulism in posterior maxilla
  • >8 mm available bone height (distance between bone crest and maxillary sinus) and ≥7 mm bone width
  • At least 2 mm buccal keratinized mucosa width and 3 mm mucosa thickness.

Exclusion Criteria:

  • Diseases and conditions or medications which may negatively influence biological dynamics of bone and wound healing
  • Ridge deficiencies requiring additional augmentation
  • Indication of sinus lifting with crestal or lateral approach
  • Endodontic or periodontal lesions neighbouring the edentulous sites were anatomic exclusion criteria
Publications of Results:

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Responsible Party: Gözde Peker Tekdal, Principal Investigator, Ege University
ClinicalTrials.gov Identifier: NCT03538184    
Other Study ID Numbers: BAP 2013 Dent 009
First Posted: May 29, 2018    Key Record Dates
Last Update Posted: May 29, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Jaw, Edentulous
Tooth Loss
Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases
Periodontal Diseases
Jaw Diseases
Musculoskeletal Diseases