New treatment for multiple gum recession defects using a collagen membrane
Mucogain Matrix Versus Connective Tissue Graft: "MUCOGREFFE Project"
This study is testing a new collagen membrane treatment for people with multiple gum recession defects to see if it works better than the usual tissue grafts.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nice Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Nice, Provence Alpes Cote d'Azur) |
| Trial ID | NCT04800250 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a new xenogenic collagen membrane in treating multiple gingival recession defects compared to traditional connective tissue grafts. The study will involve patients with specific types of gingival recessions, utilizing a tunnel technique to apply the mucogain matrix. Participants will be monitored for outcomes related to gum recovery and overall oral health. The goal is to determine if this new approach can reduce donor site limitations and postoperative complications associated with connective tissue grafts.
Who should consider this trial
Good fit: Ideal candidates are non-smoking patients with three contiguous, symmetrical, and bilateral RTI Cairo gingival recessions classified as Miller Class 1.
Not a fit: Patients with severe systemic health issues, recent cancer treatments, or poor oral hygiene may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a less invasive and more effective option for patients suffering from gingival recession.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using alternative materials for gum treatment, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nice, Provence Alpes Cote d'Azur
- CHU de Nice — Nice, Provence Alpes Cote d'Azur, France (Recruiting)
Study contacts
- Study coordinator: Séverine I Vincent Bugnas
- Email: vincent-bugnas.s@chu-nice.fr
- Phone: 0492033270
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.