Adjunctive Use of Dermal Matrix to Compensate Dimensional Changes in the Reconstructive Therapy of Peri-implantitis
- Conditions
- Peri-Implantitis
- Interventions
- Other: No dermal matrixOther: Dermal matrix (Oracell, LifeNet, USA)
- Registration Number
- NCT06398288
- Lead Sponsor
- Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
- Brief 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 48
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group (no Oracell group) No dermal matrix Control group: 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) Test group (Oracell group) 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)
- Primary Outcome Measures
Name Time Method Rate of disease resolution of peri-implantitis (%) 12 months No bleeding, no pocket depth ≥6mm, no progressive bone loss. Appraised in %
- Secondary Outcome Measures
Name Time Method Reduction in mm of mucosal recession 12 months Migration of the mucosal margin from baseline position in relation to the implant-abutment/prosthesis connection. Appraised in mm
Evolution of microbial profile (characteristics of the microbiota) 12 months Microbiological samples will be taken with sterile endodontic paper points (Absorbent paper point size 30, Denstsply, Maillefer, Ballaigues, Switzerland) from the peri-implant sulcus of patients with implants diagnosed with peri-implantitis. In the event that the same patient has several implants with a diagnosis of peri-implantitis, separate samples will be taken from each peri-implant environment.
* T=0. Submucosal microbiological sampling prior to the non-surgical phase. Before instrumentation. Intact environment.
* T=1. Submucosal microbiological sampling prior to the surgical phase. Before the start of surgery. Environment evolved after instrumentation.
* T=2. Submucosal microbiological sampling after 2 weeks of reconstructive surgery. After removing sutures, perform sampling.
* T=3. Submucosal microbiological sampling 6 months of follow-up.
* T=4. Submucosal microbiological sampling 12 months of follow-up.
Trial Locations
- Locations (1)
Centro de Implantologia Cirugia Oral y Maxiofacial
🇪🇸Badajoz, Spain