Treatments to reduce interdental black triangles
Efficacy of Nonsurgical Versus Surgical Management of Black Triangles: A Randomized Clinical Trial
NA · Ain Shams University · NCT07548203
This trial will try three methods—surgical tube grafting, hyaluronic acid injections, and a composite injection-molding technique—to close or reduce interdental black triangles in adults with mild to moderate papilla loss.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Ain Shams University (other) |
| Locations | 1 site (Cairo) |
| Trial ID | NCT07548203 on ClinicalTrials.gov |
What this trial studies
Thirty adult patients with Nordland and Tarnow Class I or II interdental papillary loss will be randomly assigned to one of three treatment arms: surgical tube grafting, hyaluronic acid (HA) injection, or injection-molding composite restoration. Clinical measurements and standardized photographs will be taken at baseline and at follow-up visits, with primary comparisons made at 3 and 6 months. Outcomes will include papillary fill, esthetic appearance, and any functional improvements such as reduced food impaction. The trial is conducted at the Faculty of Dentistry, King Salman International University, with eligibility limited to systemically healthy, non-smoking adults with adequate interdental bone support.
Who should consider this trial
Good fit: Ideal participants are systemically healthy adults aged 18–50 with Nordland and Tarnow Class I or II papilla loss, radiographic contact-to-crest distance ≤5 mm, and willingness to attend in-person follow-ups.
Not a fit: Patients with advanced papillary loss (Class III), active periodontal disease, poor bone support, smoking or systemic conditions that impair healing are unlikely to benefit from these approaches.
Why it matters
Potential benefit: If successful, the tested methods could reduce visible black triangles and improve smile esthetics and oral function with options ranging from minimally invasive to surgical repair.
How similar studies have performed: Previous case series and small clinical reports support surgical papilla grafting and show promising but variable results for HA injections and restorative molding, so the evidence is encouraging but not definitive.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 to 50 years. Presence of interdental black triangle classified as Nordland and Tarnow Class I or Class II. Radiographic evidence of adequate interdental bone support, defined as ≤5 mm distance from the contact point to the alveolar crest. Systemically healthy individuals with no medical conditions affecting wound healing. Patients willing to participate in the study and attend follow-up visits at 3 and 6 months. Exclusion Criteria: * Patients with systemic diseases that may impair wound healing. Presence of teeth with acute periapical pathology. Presence of periodontal pockets or active periodontal disease. Pregnant or lactating women. Patients with parafunctional habits (e.g., bruxism). Smokers, alcoholics, or drug abusers.
Where this trial is running
Cairo
- Faculty of Dentistry, King Salman International University — Cairo, Egypt (RECRUITING)
Study contacts
- Principal investigator: Fatma E.A. Fatma E.A., PHD — Assistant Professor Of Oral Medicine, Periodontology, Oral Diagnosis
- Study coordinator: Fatma E.A. Hassanein, PHD
- Email: fatma.hassanein@ksiu.edu.eg
- Phone: +201000093885
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.
Conditions: Black Triangles Syndrome, Papilla Reconstruction