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

Sponsor

Centre Hospitalier Universitaire de Nice (Other)

Overall Status

Recruiting

CT.gov ID

NCT04800250

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Gingival Recession	Procedure: Treatment of gingival recessions	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Case-controlCase-control

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Mucogain Matrix Versus Connective Tissue Graft: "MUCOGREFFE Project"

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Mean root coverage obtained with both techniques [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).

Secondary Outcome Measures

Postoperative pain with both techniques [6 months]
To compare postoperative pain with both techniques
Postoperative complications with both techniques [10 days]
To compare the occurrence of postoperative complications (haemorrhage, edema) within the first 10 days.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Nice	Nice	Provence Alpes Cote d'Azur	France	06000

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nice

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Nice

ClinicalTrials.gov Identifier:

NCT04800250

Other Study ID Numbers:

20-PP-26

First Posted:

Mar 16, 2021

Last Update Posted:

Jul 7, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Gingival Recession

Study Results

No Results Posted as of Jul 7, 2022