Rebuilding the gum papilla with three methods
Restoring Lost Pink Triangle by Comparing Three Different Papillary Reconstruction Modalities: A Randomized Clinical Trial
This study will try three ways—hyaluronic acid injections (with possible booster doses), slow-resorbing ALB-PRF injections, and a minimally invasive modified Beagle surgery—to restore lost interdental papilla in adults with class 1–2 papilla defects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 20 Years to 50 Years |
| Sex | All |
| Sponsor | Mansoura University Academic / other |
| Locations | 1 site (Al Mansurah, Dakahlia Governorate) |
| Trial ID | NCT07159802 on ClinicalTrials.gov |
What this trial studies
Participants with class 1–2 interdental papilla loss will receive one of three reconstruction techniques at a single center: hyaluronic acid injections with booster doses as needed, autologous lyophilized platelet-rich fibrin (ALB-PRF) injections intended for a slower resorption and longer effect, or a minimally invasive surgical repair modified from Beagle's technique. Treatments will be performed according to a standardized protocol and patients will be followed to document papilla fill, aesthetic outcomes, and any complications. Eligible participants are adults 20–50 years old with at least 3 mm of attached gingiva and stage 1–2 periodontitis, while smokers and those with systemic disease or other exclusions are not eligible. The trial compares clinical durability and patient-reported aesthetic results across the three modalities at Mansoura University.
Who should consider this trial
Good fit: Adults aged 20–50 with class 1 or 2 interdental papilla loss, a minimum of 3 mm attached gingiva, and stage 1–2 periodontitis who are non-smokers and can maintain oral hygiene are ideal candidates.
Not a fit: Patients with stage 3–4 periodontitis, smokers, those with chronic systemic diseases, high frenum attachment, diastema, pregnancy or lactation, or inadequate attached gingiva are unlikely to receive benefit from these procedures.
Why it matters
Potential benefit: If successful, one of these methods could offer a more reliable, longer-lasting, and less invasive way to rebuild the interdental papilla and improve smile appearance.
How similar studies have performed: Small clinical reports and case series have reported promising results for hyaluronic acid and PRF in soft-tissue papillary augmentation and mixed outcomes for surgical methods, but direct head-to-head comparisons of all three approaches are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. Age: 20 to 50 years. 2. Class 1 and 2 inter dental papilla loss according to Nordland \& Tarnow classification (17). 3\. Adequate attached gingiva (minimum 3 mm). 4. Stage 1or 2 periodontitis (18). Exclusion Criteria: * 1\. Smokers. 2. Chronic systemic diseases. 3. Drug usage. 4. High frenum attachment. 5. Diastema. 6. Pregnancy and lactation. 7. Stage 3 \& 4 periodontitis (18). 8. Noncompliance with oral hygiene measures.
Where this trial is running
Al Mansurah, Dakahlia Governorate
- Mansoura University — Al Mansurah, Dakahlia Governorate, Egypt (Recruiting)
Study contacts
- Principal investigator: Tasneem E Abdallah, BDS — Mansoura University
- Study coordinator: Tasneem E Abdallah, BDS
- Email: tasneemehabgamal@mans.edu.eg
- Phone: 01097217205
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.