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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group (Oracell group) | Experimental | 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) |
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| Control group (no Oracell group) | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dermal matrix (Oracell, LifeNet, USA) | Other | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of disease resolution of peri-implantitis (%) | No bleeding, no pocket depth ≥6mm, no progressive bone loss. Appraised in % | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in mm of mucosal recession | Migration of the mucosal margin from baseline position in relation to the implant-abutment/prosthesis connection. Appraised in mm | 12 months |
| Evolution of microbial profile (characteristics of the microbiota) |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alberto Monje, DDS | Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Implantologia Cirugia Oral y Maxiofacial | Badajoz | Badajoz | 06001 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36802084 | Background | Regidor E, Ortiz-Vigon A, Romandini M, Dionigi C, Derks J, Sanz M. The adjunctive effect of a resorbable membrane to a xenogeneic bone replacement graft in the reconstructive surgical therapy of peri-implantitis: A randomized clinical trial. J Clin Periodontol. 2023 Jun;50(6):765-783. doi: 10.1111/jcpe.13796. Epub 2023 Mar 6. | |
| 36399349 |
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| No dermal matrix | Other | 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) |
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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.
| 12 months |
| Monje A, Pons R, Vilarrasa J, Nart J, Wang HL. Significance of barrier membrane on the reconstructive therapy of peri-implantitis: A randomized controlled trial. J Periodontol. 2023 Mar;94(3):323-335. doi: 10.1002/JPER.22-0511. Epub 2022 Dec 12. |
| ID | Term |
|---|---|
| D057873 | Peri-Implantitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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