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

NCT06398288 | Recruiting DMC

• 1 other identifier: 18002604
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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)

Conditions

Peri-Implantitis

Outcome Measures

Primary Outcomes (1)

• Rate of disease resolution of peri-implantitis (%)

  No bleeding, no pocket depth ≥6mm, no progressive bone loss. Appraised in %

  12 months

Secondary Outcomes (2)

• Reduction in mm of mucosal recession

  12 months

• Evolution of microbial profile (characteristics of the microbiota)

  12 months

Study Arms (2)

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)

Other: Dermal matrix (Oracell, LifeNet, USA)

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)

Other: No dermal matrix

Interventions

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)

Test group (Oracell group)

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)

Control group (no Oracell group)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with peri-implantitis-related intrabony defects
• All subjects had dental implants with screw-retained or cement-retained fixed or removable implant-supported prosthesis for a minimum of 36 months.
• All patients in age of 18 to 80, non-smokers
• With no presence of systemic disease or medication known to alter bone metabolism, and partial or complete edentulous patients that have no active periodontal disease.

You may not qualify if:

• Peri-implantitis-related supra-crystal or combined defects
• Pregnancy or lactation
• History of or current smokers
• Uncontrolled medical conditions,
• Cement-retained restorations,
• Lacking keratinized mucosa (≤2mm) on the lingual or buccal implant sites.

Sponsors & Collaborators

• Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain: lead

Study Sites (1)

Centro de Implantologia Cirugia Oral y Maxiofacial

Badajoz, 06001, Spain

RECRUITING

Related Publications (2)

• 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.

  PMID: 36802084 BACKGROUND

• 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.

  PMID: 36399349 RESULT

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Alberto Monje, DDS

  Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mamen Tomé, DH

CONTACT

924203045; mtome@periocicom.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2024
• First Posted: May 3, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2026
• Last Updated: May 3, 2024

Record last verified: 2024-04

Locations

ES (1)