Implantoplasty as Adjunct to Combined Surgical Therapy of Peri-Implantitis

March 20, 2024 updated by: Alberto Monje, Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Badajoz, Spain, 06011
        • Recruiting
        • Centro de Implantologia Cirugia Oral y Maxilofacial
        • Contact:
        • Principal Investigator:
          • Alberto Monje, DDS, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Implantoplasty
Implantoplasty to all the implant surface
Procedure: Implantoplasty
Implantoplasty as surface decontamination method
Active Comparator: Implantoplasty on the supracrestal component
Implantoplasty only in the supra-crestal component and the infra bony hydrogen peroxide
Procedure: Implantoplasty
Implantoplasty as surface decontamination method

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of disease resolution
Time Frame: 12 months after surgery
pocket depth <6mm, no bleeding on probing, no suppuration, no progressive bone loss
12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Actual)

November 1, 2021

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

November 9, 2023

First Submitted That Met QC Criteria

November 9, 2023

First Posted (Actual)

November 14, 2023

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18102021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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