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

April 30, 2024 updated by: Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain

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

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Badajoz, Spain, 06001
        • Recruiting
        • Centro de Implantologia Cirugia Oral y Maxiofacial
        • Contact:
        • Principal Investigator:
          • Erik Regidor, DDS
        • Sub-Investigator:
          • Alberto Ortiz-Vigon, DDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria:

  • 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.

Exclusion criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test group (Oracell 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) + dermal matrix on the buccal aspect (Oracell, Lifenet Health)
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)
Experimental: Control group (no Oracell group)
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
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of disease resolution of peri-implantitis (%)
Time Frame: 12 months
No bleeding, no pocket depth ≥6mm, no progressive bone loss. Appraised in %
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in mm of mucosal recession
Time Frame: 12 months
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)
Time Frame: 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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Alberto Monje, DDS, Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

April 27, 2024

First Submitted That Met QC Criteria

April 30, 2024

First Posted (Actual)

May 3, 2024

Study Record Updates

Last Update Posted (Actual)

May 3, 2024

Last Update Submitted That Met QC Criteria

April 30, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18002604

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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