Implantoplasty as Adjunct to Combined Surgical Therapy of Peri-Implantitis

NCT06131567 | Unknown DMC

• 1 other identifier: 18102021
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Peri-Implantitis

Outcome Measures

Primary Outcomes (1)

• Rate of disease resolution

  pocket depth \<6mm, no bleeding on probing, no suppuration, no progressive bone loss

  12 months after surgery

Study Arms (2)

Implantoplasty

EXPERIMENTAL

Implantoplasty to all the implant surface

Procedure: Implantoplasty

Implantoplasty on the supracrestal component

ACTIVE COMPARATOR

Implantoplasty only in the supra-crestal component and the infra bony hydrogen peroxide

Procedure: Implantoplasty

Interventions

Implantoplasty PROCEDURE

Implantoplasty as surface decontamination method

Implantoplasty; Implantoplasty on the supracrestal component

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain: lead

Study Sites (1)

Centro de Implantologia Cirugia Oral y Maxilofacial

Badajoz, 06011, Spain

RECRUITING

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Mamen Tome Rincon, DH

CONTACT

+34924203045; mtome@periocicom.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head

Model Details: Randomized clinical trials with paired number of subjects

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 14, 2023
• Study Start: November 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2024
• Last Updated: March 21, 2024

Record last verified: 2024-01

Locations

ES (1)