Black Triangles Syndrome (BTS)BT-RCTNCT07548203
Clinical Evaluation of Different Treatments for Interdental Black Triangles
A study testing Tube Grafting Technique for Papilla Reconstruction, Hyaluronic Acid (HA) and Injection Molding Composite Technique in people with Black Triangles Syndrome (BTS) and Papilla Reconstruction, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Black Triangles Syndrome (BTS), Papilla Reconstruction
- What is being tested?
- Tube Grafting Technique for Papilla Reconstruction, Hyaluronic Acid (HA) and Injection Molding Composite Technique
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Apr 2026to 15 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, King Salman International University
Cairo
Fatma E.A. Hassanein, PHD, 01000093885, fatma.hassanein@ksiu.edu.eg
About this study
Official title: Efficacy of Nonsurgical Versus Surgical Management of Black Triangles: A Randomized Clinical 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.
Read more
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.
Read the detailed description
Interdental papilla deficiency resulting in the formation of "black triangles" is a frequent esthetic and functional problem in dentistry. These open gingival embrasures occur due to several factors including periodontal attachment loss, traumatic oral hygiene practices, tooth morphology, orthodontic treatment, and aging. In addition to compromising dental esthetics, black triangles may lead to food impaction, phonetic problems, and patient dissatisfaction with their smile.
Several therapeutic approaches have been proposed for the management of interdental papillary loss. These approaches can generally be classified into surgical and nonsurgical techniques. Surgical methods aim to reconstruct the lost papillary tissue through soft tissue grafting procedures such as the tube grafting technique. These procedures attempt to biologically restore the interdental papilla but may involve surgical morbidity and require advanced clinical skills.
Nonsurgical approaches have recently gained interest as minimally invasive alternatives. One such approach involves the use of injectable fillers such as hyaluronic acid to augment the volume of the interdental papilla. Hyaluronic acid is widely used in aesthetic medicine due to its biocompatibility and ability to promote tissue hydration and volumization. Another nonsurgical strategy is the restorative modification of tooth contours using the injection molding composite technique, which alters the shape of the proximal tooth surfaces to reduce the appearance of the gingival embrasure.
Despite the availability of these different treatment options, there is limited evidence directly comparing surgical and nonsurgical approaches for the management of interdental black triangles. Therefore, the present study aims to evaluate the efficacy of these treatment modalities in a randomized clinical trial design.
Thirty patients presenting with interdental papilla deficiency will be recruited from the outpatient clinic of the Faculty of Dentistry at King Salman International University. Eligible participants will be adults aged 18 to 50 years with Nordland and Tarnow Class I or II papillary loss and adequate interdental bone support (≤5 mm distance from the contact point to the alveolar crest). Participants with systemic diseases affecting wound healing, active periodontal disease, periapical pathology, pregnancy or lactation, parafunctional habits, or smoking history will be excluded.
After baseline assessment, participants will be randomly allocated into three equal groups:
Group I: Surgical reconstruction of the interdental papilla using the tube grafting technique.
Group II: Papillary augmentation using hyaluronic acid injection.
Group III: Restorative treatment using the injection molding composite technique.
Baseline clinical examination will include plaque index, bleeding index, probing pocket depth, and clinical attachment level. Standardized intraoral photographs will be obtained using a digital camera under controlled conditions. Image analysis software will be used to measure the surface area and height of the black triangle.
Follow-up assessments will be conducted at 3 months and 6 months after treatment. At each follow-up visit, clinical periodontal parameters and photographic measurements will be repeated. Patient satisfaction with the esthetic outcome will be evaluated using a Visual Analog Scale.
The primary outcomes of this study are the changes in black triangle surface area and height over time. Secondary outcomes include periodontal clinical parameters and patient-reported esthetic satisfaction. The results of this randomized clinical trial are expected to provide clinically relevant evidence regarding the effectiveness and stability of surgical and nonsurgical techniques for the management of interdental black triangles, contributing to evidence-based decision-making in esthetic dental practice.
- Being tested
- Tube Grafting Technique for Papilla Reconstruction, Hyaluronic Acid (HA), Injection Molding Composite Technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tube Grafting Technique for Papilla ReconstructionProcedure or surgery
Also called Papilla Tube Technique, Interdental Papilla Reconstruction 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
Also called Cross-linked Hyaluronic Acid, HA Dermal Filler
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 TechniqueProcedure or surgery
Also called Bioclear Injection Molding Technique, Composite Injection 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Injection Molding Composite Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months, and 6 months after treatment.
Secondary outcomes (2)
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.
Measured: Baseline, 3 months, and 6 months after treatment.
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.
Measured: Baseline, 3 months, and 6 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start22 Apr 2026 (estimated)
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Black Triangles Syndrome (BTS)Studies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma ElSayed, Ain Shams University
- Investigators
- Fatma E.A. Fatma E.A., PHD, Principal investigator, Assistant Professor Of Oral Medicine, Periodontology, Oral Diagnosis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07548203
- Sponsor's protocol ID
- IRB09
- Acronym
- BT-RCT
- Status last verified
- Apr 2026
- First submitted
- 11 Mar 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Nonsurgical Versus Surgical Management of Black Triangles: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07548203
- Acronym / sponsor ID
- BT-RCT / IRB09
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 22 Apr 2026 (estimated)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 23 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Interdental papilla deficiency resulting in the formation of "black triangles" is a frequent esthetic and functional problem in dentistry. These open gingival embrasures occur due to several factors including periodontal attachment loss, traumatic oral hygiene practices, tooth morphology, orthodontic treatment, and aging. In addition to compromising dental esthetics, black triangles may lead to food impaction, phonetic problems, and patient dissatisfaction with their smile.
Several therapeutic approaches have been proposed for the management of interdental papillary loss. These approaches can generally be classified into surgical and nonsurgical techniques. Surgical methods aim to reconstruct the lost papillary tissue through soft tissue grafting procedures such as the tube grafting technique. These procedures attempt to biologically restore the interdental papilla but may involve surgical morbidity and require advanced clinical skills.
Nonsurgical approaches have recently gained interest as minimally invasive alternatives. One such approach involves the use of injectable fillers such as hyaluronic acid to augment the volume of the interdental papilla. Hyaluronic acid is widely used in aesthetic medicine due to its biocompatibility and ability to promote tissue hydration and volumization. Another nonsurgical strategy is the restorative modification of tooth contours using the injection molding composite technique, which alters the shape of the proximal tooth surfaces to reduce the appearance of the gingival embrasure.
Despite the availability of these different treatment options, there is limited evidence directly comparing surgical and nonsurgical approaches for the management of interdental black triangles. Therefore, the present study aims to evaluate the efficacy of these treatment modalities in a randomized clinical trial design.
Thirty patients presenting with interdental papilla deficiency will be recruited from the outpatient clinic of the Faculty of Dentistry at King Salman International University. Eligible participants will be adults aged 18 to 50 years with Nordland and Tarnow Class I or II papillary loss and adequate interdental bone support (≤5 mm distance from the contact point to the alveolar crest). Participants with systemic diseases affecting wound healing, active periodontal disease, periapical pathology, pregnancy or lactation, parafunctional habits, or smoking history will be excluded.
After baseline assessment, participants will be randomly allocated into three equal groups:
Group I: Surgical reconstruction of the interdental papilla using the tube grafting technique.
Group II: Papillary augmentation using hyaluronic acid injection.
Group III: Restorative treatment using the injection molding composite technique.
Baseline clinical examination will include plaque index, bleeding index, probing pocket depth, and clinical attachment level. Standardized intraoral photographs will be obtained using a digital camera under controlled conditions. Image analysis software will be used to measure the surface area and height of the black triangle.
Follow-up assessments will be conducted at 3 months and 6 months after treatment. At each follow-up visit, clinical periodontal parameters and photographic measurements will be repeated. Patient satisfaction with the esthetic outcome will be evaluated using a Visual Analog Scale.
The primary outcomes of this study are the changes in black triangle surface area and height over time. Secondary outcomes include periodontal clinical parameters and patient-reported esthetic satisfaction. The results of this randomized clinical trial are expected to provide clinically relevant evidence regarding the effectiveness and stability of surgical and nonsurgical techniques for the management of interdental black triangles, contributing to evidence-based decision-making in esthetic dental practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Surgical Tube Technique | Experimental | Procedure: Tube Grafting Technique for Papilla ReconstructionParticipants 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. |
| Hyaluronic Acid Injection | Experimental | Drug: Hyaluronic Acid (HA)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. |
| Injection Molding Restorative Technique | Experimental | Procedure: Injection Molding Composite TechniqueParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tube Grafting Technique for Papilla ReconstructionAlso: Papilla Tube Technique, Interdental Papilla Reconstruction SurgeryA 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. | Procedure or surgery | Surgical Tube Technique |
| Hyaluronic Acid (HA)Also: Cross-linked Hyaluronic Acid, HA Dermal FillerA 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. | Drug | Hyaluronic Acid Injection |
| Injection Molding Composite TechniqueAlso: Bioclear Injection Molding Technique, Composite Injection TechniqueA 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 or surgery | Injection Molding Restorative Technique |
Primary outcome
Reduction in Black Triangle Surface Area
Time frame: Baseline, 3 months, and 6 months after treatment.
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.
2 secondary outcomes
Plaque Index
Time frame: Baseline, 3 months, and 6 months after treatment.
Bleeding on Probing
Time frame: Baseline, 3 months, and 6 months after treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Black Triangles Syndrome (BTS)
Not yet recruiting
Comparing Calcium Hydroxylapatite and Hyaluronic Acid for Interdental Papilla Reconstruction
Loss of Interdental Papillae, Black Triangles Syndrome (BTS)
Recruiting
Evaluation of the Safety and Performance of the Medical Device RDM36 in the Treatment of Periodontal Gingival Contraction and in Black Triangles Syndrome (BTS)
Black Triangles Syndrome (BTS), Periodontal Gingival Contraction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fatma E.A. Fatma E.A., PHD principal investigator
Assistant Professor Of Oral Medicine, Periodontology, Oral Diagnosis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tube Grafting Technique for Papilla Reconstruction, Hyaluronic Acid (HA) and Injection Molding Composite Technique in people with Black Triangles Syndrome (BTS) and Papilla Reconstruction, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatma E.A. Hassanein, PHD (+201000093885, fatma.hassanein@ksiu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Black Triangle Surface Area (time frame: Baseline, 3 months, and 6 months after treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.