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

Gingival Recession Clinical Trial

— Mucogreffe  

Official title:

Mucogain Matrix Versus Connective Tissue Graft: "MUCOGREFFE Project"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04800250
• Other study ID #: 20-PP-26
• Status: Recruiting
• Phase: N/A
• Start date: July 24, 2023
• Est. completion date: January 2025

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Séverine I Vincent Bugnas
• Phone: 0492033270
• Email: vincent-bugnas.s[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gingival Recession

Intervention

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

Locations

Country	Name	City	State
France	CHU de Nice	Nice	Provence Alpes Cote d'Azur

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	6 months
Secondary	Postoperative pain with both techniques	To compare postoperative pain with both techniques	6 months
Secondary	Postoperative complications with both techniques	To compare the occurrence of postoperative complications (haemorrhage, edema) within the first 10 days.	10 days