NCT05282667

Reconstructive Management of Peri-implantitis

Significance of Barrier Membrane in the Reconstructive Management of Peri-implantitis: A RCT

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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

Conditions

• Resolution of Pathologic Process

Interventions

Type	Name	Description
PROCEDURE	Reconstructive therapy of peri-implantitis by means of bone graft (and barrier membrane in the test group)	A full-thickness flap was raised to ensure sufficient access. Debridement of granulation tissue was subsequently conducted using a "mini-five" curette (Hu-Friedy) and site-specific Gracey curettes (Hu-Friedy). The surgical approach was tailored to the clinical scenario. Specifically, resective therapy by means of implantoplasty was performed for supracrestal defects (Meisinger LLC, Nauss, Germany). Surface detoxification was performed with 3% hydrogen peroxide during 2 minutes and irrigation with 0.12% chlorhexidine. The intraosseous compartment was grafted using mineralized and demineralized bone graft (LifeNet Health, Virginia, USA). The graft was compartmentalized in the test group with a collagen porcine resorbable membrane (RTM, Cytoplast, California, USA) adapted to the defect morphology. Nylon 5.0 (Resorba Sutures, Osteogenics Biomedical, Lubbock, Texas) was used for suturing, ensuring primary wound closure

Timeline

• Start date: 2019-03-27
• Primary completion: 2022-11-15
• Completion: 2022-11-16
• First posted: 2022-03-16
• Last updated: 2024-12-05

Locations

1 site across 1 country: Spain