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

NCT ID: NCT04800250

Last Updated: 2024-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-24

Study Completion Date

2025-01-31

Brief Summary

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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

Detailed Description

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Conditions

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Gingival Recession

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Case-control
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A - Mucogain matrix on right

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

Group Type EXPERIMENTAL

Treatment of gingival recessions

Intervention Type 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

B - Mucogain matrix on left

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

Group Type EXPERIMENTAL

Treatment of gingival recessions

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Nice

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

Site Status RECRUITING

Countries

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France

Central Contacts

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Séverine I Vincent Bugnas

Role: CONTACT

0492033270

Facility Contacts

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Séverine Vincent Bugnas

Role: primary

0492033270

Other Identifiers

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20-PP-26

Identifier Type: -

Identifier Source: org_study_id

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