Comparing Amnion Membrane and Free Gingival Graft for Treating Gum Recession
Amnion Membrane as a Soft Tissue Substitute Versus De- Epithelialized Free Gingival Graft Using the Tunneling Technique in Management of Gingival Recession Defects: A Randomized Controlled Clinical Trial.
This study is testing whether using Amnion Membrane or Free Gingival Graft works better for treating gum recession in healthy people.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06146855 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of two surgical techniques for managing gingival recession defects: the tunneling procedure using Amnion Membrane and the tunneling procedure using De-epithelialized Free Gingival Graft. The goal is to determine which method provides better outcomes in terms of root coverage and patient morbidity. Participants will be assessed based on specific inclusion and exclusion criteria, ensuring a focus on healthy individuals with particular types of gingival recession. The study aims to contribute to the ongoing debate regarding the best surgical approach for this common dental issue.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 to 60 with specific types of gingival recession defects.
Not a fit: Patients with more severe recession defects, smokers, or those with certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into more effective and less invasive treatment options for patients with gingival recession.
How similar studies have performed: Previous studies have shown varying success with similar surgical techniques, but this specific comparison is less explored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 and 60 years. * Periodontally and systemically healthy. * Presence of RT1 or RT2 buccal gingival recession defects ≥2 mm in depth. * Full-mouth plaque and bleeding score of \<15% and no probing depths \>3 mm. * Absence of non-carious cervical lesions (NCCLs) and non-detectable cemento-enamel junction (CEJ) at the defect sites. Exclusion Criteria: * RT3 recession defects. * Smokers as smoking is a contraindication for any plastic periodontal surgery (Khuller, 2009). * Presence of caries lesions or restorations in the cervical area. * Intake of medications which impede periodontal tissue health and healing. * Medical contraindications for periodontal surgical procedures. * Uncooperative patients not willing to complete the follow up period. * Pregnancy and lactation.
Where this trial is running
Cairo
- Faculty of Oral and Dental Medicine — Cairo, Egypt (Recruiting)
Study contacts
- Principal investigator: Mohamed Mashaly, MSc — Assistant lecturer of Periodontology, Cairo University
- Study coordinator: Mohamed Mashaly, MSc
- Email: mohamed.mashaly@dentistry.cu.edu.eg
- Phone: 00201226442241
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.