Health TrialsbyHealthPanel

Clinical Evaluation of Different Treatments for Interdental Black Triangles

ConditionsBlack Triangles Syndrome (BTS)Papilla Reconstruction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorAin Shams University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 to 50 years.

Disqualifiers

Patients with systemic diseases that may impair wound healing.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tube Grafting Technique for Papilla Reconstruction

    Procedure/Surgery

    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.

  • Hyaluronic Acid (HA)

    Drug

    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.

  • Injection Molding Composite Technique

    Procedure/Surgery

    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.

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Surgical Tube TechniqueExperimental treatment 1 intervention
Group B: Hyaluronic Acid InjectionExperimental treatment 1 intervention
Group C: Injection Molding Restorative TechniqueExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Reduction in Black Triangle Surface Area

The primary outcome will be the quantitative change in the surface area of the interdental black triangle. Measurements will be obtained from standardized intraoral photographs and analyzed using digital image analysis software. Surface area will be calculated in square millimeters (mm²). The outcomes will be compared between treatment groups to evaluate the effectiveness of the interventions in reducing interdental papillary deficiency.

Time frame
Baseline, 3 months, and 6 months after treatment.

Secondary outcomes

1

Plaque Index

Plaque accumulation around the treated teeth will be assessed using a periodontal probe and recorded according to a standardized plaque index scoring system. This measure will be used to evaluate oral hygiene status and its potential influence on treatment outcomes.

Time frame
Baseline, 3 months, and 6 months after treatment.
2

Bleeding on Probing

Bleeding on probing will be recorded during periodontal examination to evaluate gingival inflammation around the treated sites. The presence or absence of bleeding after gentle probing will be documented as an indicator of periodontal health.

Time frame
Baseline, 3 months, and 6 months after treatment.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov
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