Implantoplasty as Adjunct to Combined Surgical Therapy of Peri-Implantitis: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Rate of disease resolution
Study Overview
Brief Summary
Implantoplasty entails polishing of the implant surface during the surgical therapy of peri-implantitis. Given the controversy behind implantoplasty as surface decontamination method in the treatment of peri-implantitis, the goal of this clinical trial is to assess the clinical resolution and radiographic bone gain in peri-implantitis sites treated by means of reconstructive therapy (Inteross® + autogenous bone, Sigmagraft, CA, USA) + implantoplasty in combined defects when compared to the extent of implantoplasty along the exposed implant surface upon the clinical resolution and radiographic bone gain in peri-implantitis sites treated by means of reconstructive therapy (Inteross® + autogenous bone, Sigmagraft, CA, USA).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •All patients in age of 18 to 80, non-smokers
- •With no presence of systemic disease or medication known to alter bone metabolism, and partial or complete edentulous patients that have no active periodontal disease.
- •Peri-implantitis defined according to the EFP/AAP consensus meeting
- •Combined defect configuration
Exclusion Criteria
- •Pregnancy or lactation
- •History of or current smokers
- •Uncontrolled medical conditions,
- •Cement-retained restoration
- •Lacking keratinized mucosa (≤2mm) on the lingual or buccal implant sites.
Arms & Interventions
Implantoplasty
Implantoplasty to all the implant surface
Intervention: Implantoplasty (Procedure)
Implantoplasty on the supracrestal component
Implantoplasty only in the supra-crestal component and the infra bony hydrogen peroxide
Intervention: Implantoplasty (Procedure)
Outcomes
Primary Outcomes
Rate of disease resolution
Time Frame: 12 months after surgery
pocket depth \<6mm, no bleeding on probing, no suppuration, no progressive bone loss
Secondary Outcomes
No secondary outcomes reported
Investigators
Alberto Monje
Head
Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain