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 ]
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 ]
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