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

NCT04800250 | Recruiting DMC

• 1 other identifier: 20-PP-26
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Postoperative pain with both techniques

  6 months

• Postoperative complications with both techniques

  10 days

Study Arms (2)

A - Mucogain matrix on right

EXPERIMENTAL

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

Procedure: Treatment of gingival recessions

B - Mucogain matrix on left

EXPERIMENTAL

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

Procedure: Treatment of gingival recessions

Interventions

Treatment of gingival recessions PROCEDURE

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

A - Mucogain matrix on right; B - Mucogain matrix on left

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, Provence-Alpes-Côte d'Azur Region, 06000, France

RECRUITING

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Central Study Contacts

Séverine I Vincent Bugnas

CONTACT

0492033270; vincent-bugnas.s@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Case-control

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 16, 2021
• Study Start: July 24, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)