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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)

Primary Purpose

Gingival Recession

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Treatment of gingival recessions

About this trial

This is an interventional treatment trial for Gingival Recession

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CHU de NiceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

A - Mucogain matrix on right

B - Mucogain matrix on left

Arm Description

The patient will receive mucogain matrix on right side and connective tissue graft on left side.

The patient will receive mucogain matrix on left side and connective tissue graft on right side.

Outcomes

Primary Outcome Measures

Mean root coverage obtained with both techniques

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).

Secondary Outcome Measures

Postoperative pain with both techniques

To compare postoperative pain with both techniques

Postoperative complications with both techniques

To compare the occurrence of postoperative complications (haemorrhage, edema) within the first 10 days.

Full Information

NCT ID

NCT04800250

First Posted

March 12, 2021

Last Updated

July 26, 2023

Sponsor

Centre Hospitalier Universitaire de Nice

1. Study Identification

Unique Protocol Identification Number

NCT04800250

Brief Title

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

Acronym

Mucogreffe

Official Title

Mucogain Matrix Versus Connective Tissue Graft: "MUCOGREFFE Project"

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 24, 2023 (Actual)

Primary Completion Date

January 2025 (Anticipated)

Study Completion Date

January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gingival Recession

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Case-control

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

A - Mucogain matrix on right

Arm Type

Experimental

Arm Description

The patient will receive mucogain matrix on right side and connective tissue graft on left side.

Arm Title

B - Mucogain matrix on left

Arm Type

Experimental

Arm Description

The patient will receive mucogain matrix on left side and connective tissue graft on right side.

Intervention Type

Procedure

Intervention Name(s)

Treatment of gingival recessions

Intervention Description

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

Primary Outcome Measure Information:

Title

Mean root coverage obtained with both techniques

Description

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).

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Postoperative pain with both techniques

Description

To compare postoperative pain with both techniques

Time Frame

6 months

Title

Postoperative complications with both techniques

Description

To compare the occurrence of postoperative complications (haemorrhage, edema) within the first 10 days.

Time Frame

10 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Séverine I Vincent Bugnas

Phone

0492033270

vincent-bugnas.s@chu-nice.fr

Facility Information:

Facility Name

CHU de Nice

City

Nice

State/Province

Provence Alpes Cote d'Azur

ZIP/Postal Code

06000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Séverine Vincent Bugnas

Phone

0492033270

vincent-bugnas.s@chu-nice.fr

First Name & Middle Initial & Last Name & Degree

Séverine VINCENT-BUGNAS, PH

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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