Treatment of Multiple Gingival Recession Defects Using a New Xenogenic Collagen Membrane Compared to Connective Tissue Graft: a Randomized Controlled Split-mouth Clinical Study (Mucogreffe)

February 8, 2024 updated by: Centre Hospitalier Universitaire de Nice

Mucogain Matrix Versus Connective Tissue Graft: "MUCOGREFFE Project"

Limitation of donor site and significant postoperative morbidity are often described in connective tissue graft. We want to show if mucogain matrix used in tunnel technique to recover RTI Cairo recessions defects could be an alternative to connective tissue graft

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

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

  • France
    • Provence Alpes Cote d'Azur
      • Nice, Provence Alpes Cote d'Azur, France, 06000
        • Recruiting
        • CHU de Nice
        • Contact:
        • Principal Investigator:
          • Séverine VINCENT-BUGNAS, PH

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Patient with 3 contiguous, symmetrical and bilateral RTI Cairo gingival recessions (Miller Class 1) (i.e. 6 recessions)
  • Patient non-smoker
  • Patient affiliated to social security
  • Patient signed informed consent.

Exclusion criteria:

  • Patient with or having presented an acute or chronic severe cardiovascular, kidney, liver, gastrointestinal, allergic, endocrine, neuropsychiatric pathology, developed cancer of the upper aero digestive tract treated with radiotherapy
  • Patient with severe hemorrhinopathy
  • Patient treated with oral retinoids, bisphosphonates, oral or anticonvulsants
  • Patient who has taken steroidal or non-steroidal anti-inflammatory therapy, anti-cancer or immunosuppressive chemotherapy within the last 6 months.
  • Patient with contraindication to necessary and pre-, per- or post-operative treatments
  • Follow-up of the patient seemed difficult by the investigator
  • Patient with insufficient oral hygiene incompatible with oral surgery

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: A - Mucogain matrix on right
The patient will receive mucogain matrix on right side and connective tissue graft on left side.
Procedure: Treatment of gingival recessions
Patients will have a surgery for their gingival recessions. They will be enrolled in the split mouth-study. They will have on one side mucogain matrix transplant, an on another side they will have the gold standard procedure
Experimental: B - Mucogain matrix on left
The patient will receive mucogain matrix on left side and connective tissue graft on right side.
Procedure: Treatment of gingival recessions
Patients will have a surgery for their gingival recessions. They will be enrolled in the split mouth-study. They will have on one side mucogain matrix transplant, an on another side they will have the gold standard procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean root coverage obtained with both techniques
Time Frame: 6 months
To compare the mean root coverage obtained with the Creos® Mucogain matrix and connective tissue graft in the treatment of Cairo RT1 class maxillary recessions (Miller Class 1).
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain with both techniques
Time Frame: 6 months
To compare postoperative pain with both techniques
6 months
Postoperative complications with both techniques
Time Frame: 10 days
To compare the occurrence of postoperative complications (haemorrhage, edema) within the first 10 days.
10 days

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Nice

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)

July 24, 2023

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

March 12, 2021

First Submitted That Met QC Criteria

March 12, 2021

First Posted (Actual)

March 16, 2021

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-PP-26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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