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NCT06131567 Clinical Trial

Implantoplasty as Adjunct to Combined Surgical Therapy of Peri-Implantitis

Peri-Implantitis Clinical Trial

Official title:
Implantoplasty as Adjunct to Combined Surgical Therapy of Peri-Implantitis: A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06131567
Other study ID # 18102021
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2021
Est. completion date November 2024

Study information
Verified date January 2024
Source Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
Contact Mamen Tome Rincon, DH
Phone +34924203045
Email mtome@periocicom.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date November 2024
Est. primary completion date November 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 80 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Implantoplasty
Implantoplasty as surface decontamination method

Locations
Country Name City State
Spain Centro de Implantologia Cirugia Oral y Maxilofacial Badajoz

Sponsors (1)
Lead Sponsor Collaborator
Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of disease resolution pocket depth <6mm, no bleeding on probing, no suppuration, no progressive bone loss 12 months after surgery
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