Clinical Evaluation of Different Treatments for Interdental Black Triangles

NCT07548203 | Recruiting

• 1 other identifier: IRB09
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

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.

  Baseline, 3 months, and 6 months after treatment.

Secondary Outcomes (2)

• Plaque Index

  Baseline, 3 months, and 6 months after treatment.

• Bleeding on Probing

  Baseline, 3 months, and 6 months after treatment.

Study Arms (3)

Surgical Tube Technique

EXPERIMENTAL

Participants in this arm will receive surgical reconstruction of the interdental papilla using the tube grafting technique. The procedure involves local anesthesia, preparation of the recipient site, and placement of a connective tissue graft to augment the interdental papilla. The graft will be stabilized to promote papillary regeneration and closure of the black triangle.

Procedure: Tube Grafting Technique for Papilla Reconstruction

Hyaluronic Acid Injection

EXPERIMENTAL

Participants in this arm will receive papillary augmentation using hyaluronic acid gel injection. A controlled volume of cross-linked hyaluronic acid (\<0.2 ml) will be injected into the interdental papilla to increase tissue volume and reduce the appearance of the black triangle.

Drug: Hyaluronic Acid (HA)

Injection Molding Restorative Technique

EXPERIMENTAL

Participants in this arm will receive restorative treatment using the injection molding composite technique. A matrix system will be used to guide composite placement, and heated flowable composite resin will be injected to modify proximal tooth contours and reduce the gingival embrasure space responsible for the black triangle.

Procedure: Injection Molding Composite Technique

Interventions

Tube Grafting Technique for Papilla Reconstruction PROCEDURE

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.

Also known as: Papilla Tube Technique, Interdental Papilla Reconstruction Surgery

Surgical Tube Technique

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.

Also known as: Cross-linked Hyaluronic Acid, HA Dermal Filler

Hyaluronic Acid Injection

Injection Molding Composite Technique PROCEDURE

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.

Also known as: Bioclear Injection Molding Technique, Composite Injection Technique

Injection Molding Restorative Technique

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry, King Salman International University

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Hyaluronic Acid

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Fatma E.A. Fatma E.A., PHD

  Assistant Professor Of Oral Medicine, Periodontology, Oral Diagnosis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatma E.A. Hassanein, PHD

CONTACT

+201000093885; fatma.hassanein@ksiu.edu.eg

Fatma E.A. Hassanein, PHD

CONTACT

01000093885; fatma.hassanein@ksiu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessment will be performed by an independent examiner who is blinded to the treatment allocation. The examiner responsible for measuring the black triangle dimensions and recording clinical parameters will not be involved in delivering the interventions and will remain unaware of which treatment each participant received. Standardized intraoral photographs will be coded and analyzed without identifiers indicating the assigned treatment group to maintain assessor blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of oral medicine and periodontology

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: April 23, 2026
• Study Start: April 22, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

EG (1)