Reconstructive Management of Peri-implantitis

Not Applicable

Completed

• Conditions: Resolution of Pathologic Process
• Interventions: Procedure: Reconstructive therapy of peri-implantitis by means of bone graft (and barrier membrane in the test group)

• Registration Number: NCT05282667
• Lead Sponsor: Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain

Brief Summary

With the growing burden of peri-implantitis around the globe, interest has flourished on the management of this pathology. Nevertheless, lack of consensus exists in the pursuit of a predictable therapy. Different therapeutic modalities have been advocated. Non-surgical therapy as a sole modality is often insufficient to resolve inflammation. Surgical interventions have demonstrated more favorable outcomes. Amongst these, evidence supported the application of resective, reconstructive, or combined approaches to limit progressive bone loss and achieve soft tissue health. Nevertheless, up to date, the most suitable modality remains unknown and the decision-making process derives from the understanding acquired from the management of periodontitis.

One critical element regarded to successfully resolve peri-implantitis is to efficiently detoxify the contaminated implant surface. Mechanical, pharmacological and chemical strategies have been proposed to eliminate bacterial plaque and remnants from the implant surface. However, evidence has not demonstrated superiority of a given detoxification agent/strategy.

In this sense, the significance of barrier membranes is not yet well understood. Roos-Jansaker in 2014 showed that the additional use of barrier membranes did not improve the outcome. Nevertheless, since then this subject has not been a matter of research.

Detailed Description

The effect of barrier membrane in the reconstructive management of peri-implantitis will be tested at 12-month follow-up

Study Timeline

• Study Start: 2019-03-27
• Study First Submitted: 2021-09-12
• Study First Submitted QC: 2022-03-07
• Study First Posted: 2022-03-16
• Primary Completion: 2022-11-15
• Study Completion: 2022-11-16
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Non-smokers
• No use of antibiotics recently
• No metabolic disorder
• Infra-osseous or combined peri-implantitis defect

Exclusion Criteria

• Smokers
• Pregnant
• Metabolic disorders that affect bone healing
• Supra-crestal defects

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resorbable cross-linked barrier membrane	Reconstructive therapy of peri-implantitis by means of bone graft (and barrier membrane in the test group)	Bone graft will be covered with a resorbable barrier membrane to exclude undesired cells from the area aimed at being regenerated (peri-implantitis bone defect)
No barrier membrane	Reconstructive therapy of peri-implantitis by means of bone graft (and barrier membrane in the test group)	Bone graft will be solely packed in the peri-implantitis bone defect with no membrane to cover

Primary Outcome Measures

Name	Time	Method
Changes in clinical parameters	12 months	Number of patients where the disease was resolved. At implant level the changes in bleeding on probing and changes in probing pocket depths will be recorded as well

Secondary Outcome Measures

Name	Time	Method
Changes in Bone level	12-month follow-up	Change in Bone level measured in mm from x-rays obtained from the comparative between baseline bone level and bone level determined at 12-month follow-up

Trial Locations

Locations (1)

Clinica CICOM; 🇪🇸 Badajoz, Spain