Clinical Trial: Peri-Implantitis Surgical Treatment an RCT Study

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Regenerative Treatment of Peri-Implantitis: Double Blind Randomized Controlled Clinical Trial

Brief Summary: The purpose of this experimental study in humans is to evaluate and compare, the regenerative therapy for the treatment of peri-implantitis using different bone substitutes and absorbable membranes with surgical therapy without the use of materials for regeneration.

Detailed Summary:

Specifics aims

  • Compare radiographic and clinical results of guided bone regeneration (GBR) technique in the treatment of peri-implantitis using membrane and bone substitute (JHS HAP91 ® + JHS COL-HAP-91®) to surgical approach without bone substitutes.
  • Compare the radiographic and clinical results of GBR with surgical therapy without biomaterials
  • Evaluate radiographic changes in bone levels after GBR therapy.
  • Evaluate changes in probing depth (PD) after GBR therapy.
  • Evaluate the long term predictability of GBR and surgical therapy in the treatment of peri-implantitis.

Study Design This prospective clinical trial will recruit to clinical periodontal and peri-implant examination, individuals diagnosed with peri-implantitis who fit the eligibility criteria described below. After the clinical examination the individuals will receive oral hygiene instructions and those diagnosed with peri-implantitis will take implants standardized radiographic exams prior to surgery. Only circular and/or bowl-shaped bone defects will be selected for the study.

Sampling In this design the inclusion of at least 15 individuals is estimated for each experimental group when it performs a sample calculation with power of 90% and a significance level of 95% considering an outcome data from previous studies.

Individuals diagnosed with peri-implantitis will be recruited in two specialized private treatment centers and post graduation schools from June 2013 to June 2016. The total sample of 15 eligible implants with peri-implantitis per group will be treated (n total = 3
Sponsor: Mr. Sergio Diniz Ferreira

Current Primary Outcome: Changes in peri-implant probing depth [ Time Frame: one year and half. Pre-operative, after surgery: 6, 12 and 18 months ]

Peri-implant probing depth measured in millimeters with peri-implant probe


Original Primary Outcome: Same as current

Current Secondary Outcome: Changes in radiographic marginal bone level on standardized intraoral radiographs [ Time Frame: One year and half. Pre operative and after surgery: immediatelly, 6, 12 and 18 months ]

Evaluation of peri-implant bone level will be held through periapical x-rays taken at the time of the examination of individuals by parallelism or standardized cone along with use of radiographic film positioners and acrylic bite records for standardization of position of the radiographic taking.


Original Secondary Outcome: Same as current

Information By: Federal University of Minas Gerais

Dates:
Date Received: January 29, 2015
Date Started: September 2013
Date Completion: July 2016
Last Updated: October 11, 2015
Last Verified: October 2015