NCT06398288

Adjunctive Use of Dermal Matrix to Compensate Dimensional Changes in the Reconstructive Therapy of Peri-implantitis

Adjunctive Use of Dermal Matrix to Compensate Dimensional Changes in the Reconstructive Therapy of Peri-implantitis: Multi-Center Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

One critical element regarded to successfully resolve peri-implantitis is to efficiently decontaminate 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. Recently, the electrolytic approach has been indicated for the surgical detoxification in the management of peri-implantitis. For the electrolytic approach (EA) the implant has to be loaded negatively with a voltage and a maximum current of 600 mA. This is achieved by a device (GS1000, GalvoSurge Dental AG, Widnau, Switzerland) providing the voltage and pumping a sodium formiate solution through a spray-head, which has to be pressed into the implant by finger pressure to achieve an electrical contact. Another critical aspect in the management of peri-implantitis is related to the esthetic sequelae associated with disease resolution. Sanz-Martin et al. in a systematic review demonstrated that reconstructive therapy is less prone to exhibit mucosal recession when compared to resective therapy. Nonetheless, it seems to be unavoidable no matter the surgical intervention. Aiming at attenuating these changes, Schwarz et al. noted that the adjunctive use of connective tissue grafts may enhance the height of the mucosal level, which in turn may impact upon the esthetic outcome. Therefore, the research question is the following: What is the clinical, radiographic and 3D volumetric effectiveness of dermal matrix to improve the outcome of reconstructive therapy of peri-implantitis-related bone defects? The study is to be performed in two centers: Center of Implantology, Oral and Maxillofacial in Badajoz (Spain) and Clinical PerioCentrum Ortiz-Vigon in Bilbao (Spain)

Conditions

• Peri-Implantitis

Interventions

Type	Name	Description
OTHER	Dermal matrix (Oracell, LifeNet, USA)	Mechanical detoxification using curettes + NiTi brushes + EA (GalvoSurge) for 2 minutes + a mixture of anorganic bovine bone (Straumann Xenograft, Straumann) and cortical mineralized/demineralized allograft (Oragraft, Lifenet Health) + dermal matrix on the buccal aspect (Oracell, Lifenet Health)
OTHER	No dermal matrix	Mechanical detoxification using curettes + NiTi brushes + EA (GalvoSurge) for 2 minutes + a mixture of anorganic bovine bone (Straumann Xenograft, Straumann) and cortical mineralized/demineralized allograft (Oragraft, Lifenet Health)

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-03-01
• Completion: 2026-03-01
• First posted: 2024-05-03
• Last updated: 2024-05-03

Locations

1 site across 1 country: Spain