Clinical Evaluation of Different Treatments for Interdental Black Triangles

Summary

This randomized clinical trial aims to evaluate and compare the effectiveness of surgical and nonsurgical treatment approaches for the management of interdental black triangles. Black triangles are open gingival embrasures caused by the loss or deficiency of the interdental papilla between adjacent teeth. These spaces are a common esthetic concern and may also contribute to food impaction and periodontal problems.

Thirty adult patients presenting with interdental papillary loss classified as Nordland and Tarnow Class I or II will be recruited from the outpatient clinics of the Faculty of Dentistry at King Salman International University. Eligible participants will be randomly assigned to one of three treatment groups: surgical reconstruction using the tube grafting technique, papillary augmentation using hyaluronic acid injection, or a restorative approach using the injection molding composite technique.

Clinical and photographic assessments will be performed at baseline and during follow-up visits at 3 and 6 months after treatment. The primary outcomes will be the reduction in black triangle surface area and height. Secondary outcomes will include clinical periodontal parameters such as plaque index, bleeding score, probing pocket depth, and clinical attachment level. Patient satisfaction with the esthetic outcome will also be evaluated using a Visual Analog Scale (VAS).

The findings of this study are expected to provide evidence regarding the comparative effectiveness of surgical and nonsurgical approaches for the management of interdental black triangles and help clinicians select the most predictable treatment modality for improving esthetic outcomes.

Conditions

• Black Triangles Syndrome (BTS)
• Papilla Reconstruction

Interventions

DRUG

Hyaluronic Acid (HA)

A minimally invasive papillary augmentation procedure using injectable cross-linked hyaluronic acid gel. A controlled volume of hyaluronic acid (\<0.2 ml) is injected directly into the interdental papilla using a fine needle to increase tissue volume and improve papillary contour. The treatment aims to reduce the appearance of black triangles by enhancing soft-tissue fullness in the interdental region.

PROCEDURE

Injection Molding Composite Technique

A restorative approach used to reduce the appearance of black triangles by modifying proximal tooth contours. A matrix system is used to guide the restoration, and a bonding agent is applied followed by injection of heated flowable composite resin. The composite is shaped to alter the emergence profile and reduce the gingival embrasure space, thereby improving interdental papilla support and esthetics.

PROCEDURE

Tube Grafting Technique for Papilla Reconstruction

A surgical procedure used to reconstruct the interdental papilla for management of black triangles. Under local anesthesia, the recipient papillary area is prepared and a connective tissue graft is harvested and shaped using the tube grafting technique. The graft is inserted into the interdental area and stabilized to increase papillary volume and promote soft-tissue regeneration. The aim is to biologically reconstruct the lost papilla and reduce the gingival embrasure space.

Sponsors & Collaborators

• Ain Shams University

  lead OTHER

Principal Investigators

• Fatma E.A. Fatma E.A., PHD · Assistant Professor Of Oral Medicine, Periodontology, Oral Diagnosis

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-22

Primary Completion

2026-09-15

Completion

2026-10-15

Countries

• Egypt

Study Locations