Loss of Interdental PapillaeNCT07912294
Comparing Calcium Hydroxylapatite and Hyaluronic Acid for Interdental Papilla Reconstruction
A study testing Calcium Hydroxylapatite (CaHA) Injectable Filler. and Hyaluronic Acid (HA) Injectable Filler in people with Loss of Interdental Papillae and Black Triangles Syndrome (BTS), run by King Abdulaziz University.
Trial summary
This study aims to compare two injectable materials, calcium hydroxylapatite (Radiesse®) and hyaluronic acid, for treating gaps between the teeth caused by loss of gum tissue. These gaps, commonly known as "black triangles," can affect the appearance of a person's smile and may cause food to become trapped between the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Loss of Interdental Papillae, Black Triangles Syndrome (BTS)
- What is being tested?
- Calcium Hydroxylapatite (CaHA) Injectable Filler. and Hyaluronic Acid (HA) Injectable Filler
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Sep 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Systemically healthy individuals with no history of chronic systemic diseases.
- Patients with a healthy periodontium.
- Patients presenting with two comparable interdental papilla deficiencies in the esthetic zone.
- Patients with Class I interdental papilla loss according to the Nordland and Tarnow classification.
Who cannot join
- Patients with chronic systemic diseases.
- Pregnant or lactating women.
- Current smokers.
- Children and adolescents under 18 years of age.
About this study
Official title: Clinical Evaluation of Hyper-Diluted Calcium Hydroxylapatite Versus Hyaluronic Acid in the Reconstruction of Interdental Papilla Deficiencies: A Split-Mouth Study
This study aims to compare two injectable materials, calcium hydroxylapatite (Radiesse®) and hyaluronic acid, for treating gaps between the teeth caused by loss of gum tissue. These gaps, commonly known as "black triangles," can affect the appearance of a person's smile and may cause food to become trapped between the teeth.
Hyaluronic acid has been used to improve the appearance of these gaps, but its effects may not last for a long time. Calcium hydroxylapatite is another injectable material that may help the body produce collagen, a natural protein that supports gum tissue. This study will investigate whether calcium hydroxylapatite can provide better or longer-lasting results compared with hyaluronic acid.
Read more
The study will take place at the Faculty of Dentistry, King Abdulaziz University, Jeddah, Saudi Arabia. Approximately 20 healthy adults who have two similar gaps between their front teeth will be invited to participate.
Each participant will receive both treatments. One gap will be treated with diluted calcium hydroxylapatite, while the other will be treated with hyaluronic acid. The treatment for each site will be selected randomly to ensure a fair comparison. Each site will receive one injection.
Participants will be examined before treatment and again after 3 weeks, 3 months, and 6 months to assess the results.
During these visits, photographs and clinical measurements will be taken to evaluate changes in the size of the gaps and the amount of gum tissue between the teeth. Participants will also be asked about their satisfaction with the appearance of their gums, any discomfort experienced during treatment, and whether they have noticed an improvement in their smile. Any side effects or complications will also be recorded.
The researchers will compare how well the two materials improve the appearance of the gaps and how long the improvements last.
Participation will be voluntary, and all participants will receive information about the study before signing a consent form. Their personal information will be kept confidential, and they may withdraw from the study at any time without affecting their dental care.
The main goal of this study is to identify whether diluted calcium hydroxylapatite or hyaluronic acid provides better and longer-lasting improvement in the appearance of gaps between the teeth. The findings may help dentists choose more effective, minimally invasive treatments for patients with missing gum tissue between their teeth.
- Being tested
- Calcium Hydroxylapatite (CaHA) Injectable Filler., Hyaluronic Acid (HA) Injectable Filler
- Keywords
- Interdental papilla, Black triangle, open gingival embrasure, hyaluronic acid, Radiesse, Calcium hydroxylapatite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium Hydroxylapatite (CaHA) Injectable Filler.Device
Hyper-diluted calcium hydroxylapatite (Radiesse®) will be used for the treatment of Class I interdental papilla deficiencies. The material will be prepared at a 1:2 dilution ratio using saline and lidocaine, mixed through a Luer-lock syringe connection. Each randomly assigned interdental site will receive a single injection. The treatment aims to stimulate collagen production, improve interdental papillary fill, and enhance soft tissue volume and stability. Clinical outcomes will be evaluated at baseline, 3 weeks, 3 months, and 6 months after treatment.
Hyaluronic acid (HA) injectable filler will be used for the treatment of Class I interdental papilla deficiencies. Each randomly assigned interdental site will receive a single injection of HA to increase soft tissue volume, improve interdental papillary fill, and reduce the appearance of black triangles. Clinical outcomes will be evaluated at baseline, 3 weeks, 3 months, and 6 months after treatment.
Hyaluronic Acid (HA) Injectable FillerDevice
Hyaluronic acid (HA) injectable filler will be used for the treatment of Class I interdental papilla deficiencies. Each randomly assigned interdental site will receive a single injection of HA to increase soft tissue volume, improve interdental papillary fill, and reduce the appearance of black triangles. Clinical outcomes will be evaluated at baseline, 3 weeks, 3 months, and 6 months after treatment.
| Study group | Role | What they receive |
|---|---|---|
| Hyper-Diluted Calcium Hydroxylapatite (Radiesse®) | Experimental | Interdental papilla deficiencies assigned to this treatment will receive a single injection of hyper-diluted calcium hydroxylapatite (Radiesse®), prepared at a 1:2 dilution ratio using saline and lidocaine. The intervention aims to improve interdental papillary fill and stimulate collagen production, potentially providing longer-lasting tissue improvement. Clinical outcomes will be evaluated at baseline, 3 weeks, 3 months, and 6 months following treatment. Receives: Device: Calcium Hydroxylapatite (CaHA) Injectable Filler. |
| Hyaluronic Acid (HA) | Active comparator | Interdental papilla deficiencies assigned to this treatment will receive a single injection of hyaluronic acid (HA). The intervention aims to improve interdental papillary fill by increasing soft tissue volume and reducing the appearance of black triangles. Clinical outcomes will be evaluated at baseline, 3 weeks, 3 months, and 6 months following treatment. Receives: Device: Hyaluronic Acid (HA) Injectable Filler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Black Triangle Area
Change in the area of the open gingival embrasure (black triangle) following treatment, measured in square millimeters (mm²) using standardized calibrated digital clinical photographs. The reduction in black triangle area will be compared between the calcium hydroxylapatite and hyaluronic acid treatment sites to evaluate the effectiveness of papillary reconstruction.
Measured: Baseline, 3 weeks, 3 months, and 6 months after treatment.
Change in Interdental Papilla Height
Change in interdental papilla height (mm) from baseline following treatment with hyper-diluted calcium hydroxylapatite or hyaluronic acid. Papillary height will be measured using standardized digital clinical photographs calibrated with a UNC-15 periodontal probe and analyzed using image-analysis software (ImageJ). The distance from the papilla tip to a reference line connecting the adjacent gingival margins will be measured. Changes in papillary height will be compared between the two treatment sites.
Measured: Baseline, 3 weeks, 3 months, and 6 months after treatment.
Secondary outcomes (4)
Change in Interdental Papilla Thickness
Change in interdental papilla thickness (mm) following treatment with calcium hydroxylapatite or hyaluronic acid. Tissue thickness will be assessed using a calibrated endodontic file fitted with a silicone stopper at a standardized reference point. Changes in tissue thickness will be compared between treatment sites to estimate improvements in papillary tissue bulk.
Measured: Baseline, 3 weeks, 3 months, and 6 months after treatment.
Patient Satisfaction With Esthetic Outcomes
Patient satisfaction with the appearance of the treated interdental papilla will be assessed using a Visual Analog Scale (VAS). Participants will evaluate their satisfaction with the esthetic improvement achieved following each treatment. Satisfaction scores will be compared between the two treatment sites.
Measured: 3 weeks, 3 months, and 6 months after treatment.
Global Aesthetic Improvement Scale (GAIS)
Esthetic improvement will be assessed using the Global Aesthetic Improvement Scale (GAIS), a five-point scale ranging from "worse" to "very much improved." Both participants and investigators will evaluate the improvement in interdental papilla appearance compared with baseline. Scores will be compared between the two treatment sites.
Measured: 3 weeks, 3 months, and 6 months after treatment.
Stability of Interdental Papillary Fill
The stability of interdental papillary reconstruction will be evaluated by comparing changes in papilla height and black triangle dimensions across follow-up visits. The maintenance of treatment-related improvements at 6 months will be assessed to compare the durability of calcium hydroxylapatite and hyaluronic acid injections.
Measured: 3 weeks, 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 posted3 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Loss of Interdental PapillaeStudies of the same condition, open and under way.
- 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
- Model description
- Parallel Assignment (Split-Mouth Design) Each participant will receive both interventions at two comparable interdental papilla sites: * Group A: Hyper-diluted calcium hydroxylapatite (Radiesse®). * Group B: Hyaluronic acid (HA). The two sites will be randomly assigned to the treatments, allowing each participant to serve as their own control.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rusha Alyafi, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07912294
- Sponsor's protocol ID
- 132-09-26
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Hyper-Diluted Calcium Hydroxylapatite Versus Hyaluronic Acid in the Reconstruction of Interdental Papilla Deficiencies: A Split-Mouth Study
- ClinicalTrials.gov ID
- NCT07912294
- Acronym / sponsor ID
- 132-09-26
- Keywords
- Interdental papilla, Black triangle, open gingival embrasure, hyaluronic acid, Radiesse, Calcium hydroxylapatite
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 3 Nov 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 study aims to compare two injectable materials, calcium hydroxylapatite (Radiesse®) and hyaluronic acid, for treating gaps between the teeth caused by loss of gum tissue. These gaps, commonly known as "black triangles," can affect the appearance of a person's smile and may cause food to become trapped between the teeth.
Hyaluronic acid has been used to improve the appearance of these gaps, but its effects may not last for a long time. Calcium hydroxylapatite is another injectable material that may help the body produce collagen, a natural protein that supports gum tissue. This study will investigate whether calcium hydroxylapatite can provide better or longer-lasting results compared with hyaluronic acid.
The study will take place at the Faculty of Dentistry, King Abdulaziz University, Jeddah, Saudi Arabia. Approximately 20 healthy adults who have two similar gaps between their front teeth will be invited to participate.
Each participant will receive both treatments. One gap will be treated with diluted calcium hydroxylapatite, while the other will be treated with hyaluronic acid. The treatment for each site will be selected randomly to ensure a fair comparison. Each site will receive one injection.
Participants will be examined before treatment and again after 3 weeks, 3 months, and 6 months to assess the results.
During these visits, photographs and clinical measurements will be taken to evaluate changes in the size of the gaps and the amount of gum tissue between the teeth. Participants will also be asked about their satisfaction with the appearance of their gums, any discomfort experienced during treatment, and whether they have noticed an improvement in their smile. Any side effects or complications will also be recorded.
The researchers will compare how well the two materials improve the appearance of the gaps and how long the improvements last.
Participation will be voluntary, and all participants will receive information about the study before signing a consent form. Their personal information will be kept confidential, and they may withdraw from the study at any time without affecting their dental care.
The main goal of this study is to identify whether diluted calcium hydroxylapatite or hyaluronic acid provides better and longer-lasting improvement in the appearance of gaps between the teeth. The findings may help dentists choose more effective, minimally invasive treatments for patients with missing gum tissue between their teeth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment (Split-Mouth Design) Each participant will receive both interventions at two comparable interdental papilla sites: * Group A: Hyper-diluted calcium hydroxylapatite (Radiesse®). * Group B: Hyaluronic acid (HA). The two sites will be randomly assigned to the treatments, allowing each participant to serve as their own control.
| Arm | Type | Receives |
|---|---|---|
| Hyper-Diluted Calcium Hydroxylapatite (Radiesse®) | Experimental | Device: Calcium Hydroxylapatite (CaHA) Injectable Filler.Interdental papilla deficiencies assigned to this treatment will receive a single injection of hyper-diluted calcium hydroxylapatite (Radiesse®), prepared at a 1:2 dilution ratio using saline and lidocaine. The intervention aims to improve interdental papillary fill and stimulate collagen production, potentially providing longer-lasting tissue improvement. Clinical outcomes will be evaluated at baseline, 3 weeks, 3 months, and 6 months following treatment. |
| Hyaluronic Acid (HA) | Active comparator | Device: Hyaluronic Acid (HA) Injectable FillerInterdental papilla deficiencies assigned to this treatment will receive a single injection of hyaluronic acid (HA). The intervention aims to improve interdental papillary fill by increasing soft tissue volume and reducing the appearance of black triangles. Clinical outcomes will be evaluated at baseline, 3 weeks, 3 months, and 6 months following treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 years or older.
- Systemically healthy individuals with no history of chronic systemic diseases.
- Patients with a healthy periodontium.
- Patients presenting with two comparable interdental papilla deficiencies in the esthetic zone.
- Patients with Class I interdental papilla loss according to the Nordland and Tarnow classification.
Key exclusion criteria (4 listed)
- Patients with chronic systemic diseases.
- Pregnant or lactating women.
- Current smokers.
- Children and adolescents under 18 years of age.
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 |
|---|---|---|
| Calcium Hydroxylapatite (CaHA) Injectable Filler.Hyper-diluted calcium hydroxylapatite (Radiesse®) will be used for the treatment of Class I interdental papilla deficiencies. The material will be prepared at a 1:2 dilution ratio using saline and lidocaine, mixed through a Luer-lock syringe connection. Each randomly assigned interdental site will receive a single injection. The treatment aims to stimulate collagen production, improve interdental papillary fill, and enhance soft tissue volume and stability. Clinical outcomes will be evaluated at baseline, 3 weeks, 3 months, and 6 months after treatment. Hyaluronic acid (HA) injectable filler will be used for the treatment of Class I interdental papilla deficiencies. Each randomly assigned interdental site will receive a single injection of HA to increase soft tissue volume, improve interdental papillary fill, and reduce the appearance of black triangles. Clinical outcomes will be evaluated at baseline, 3 weeks, 3 months, and 6 months after treatment. | Device | Hyper-Diluted Calcium Hydroxylapatite (Radiesse®) |
| Hyaluronic Acid (HA) Injectable FillerHyaluronic acid (HA) injectable filler will be used for the treatment of Class I interdental papilla deficiencies. Each randomly assigned interdental site will receive a single injection of HA to increase soft tissue volume, improve interdental papillary fill, and reduce the appearance of black triangles. Clinical outcomes will be evaluated at baseline, 3 weeks, 3 months, and 6 months after treatment. | Device | Hyaluronic Acid (HA) |
Primary outcome
Reduction in Black Triangle Area
Time frame: Baseline, 3 weeks, 3 months, and 6 months after treatment.
Change in the area of the open gingival embrasure (black triangle) following treatment, measured in square millimeters (mm²) using standardized calibrated digital clinical photographs. The reduction in black triangle area will be compared between the calcium hydroxylapatite and hyaluronic acid treatment sites to evaluate the effectiveness of papillary reconstruction.
Change in Interdental Papilla Height
Time frame: Baseline, 3 weeks, 3 months, and 6 months after treatment.
Change in interdental papilla height (mm) from baseline following treatment with hyper-diluted calcium hydroxylapatite or hyaluronic acid. Papillary height will be measured using standardized digital clinical photographs calibrated with a UNC-15 periodontal probe and analyzed using image-analysis software (ImageJ). The distance from the papilla tip to a reference line connecting the adjacent gingival margins will be measured. Changes in papillary height will be compared between the two treatment sites.
4 secondary outcomes
Change in Interdental Papilla Thickness
Time frame: Baseline, 3 weeks, 3 months, and 6 months after treatment.
Patient Satisfaction With Esthetic Outcomes
Time frame: 3 weeks, 3 months, and 6 months after treatment.
Global Aesthetic Improvement Scale (GAIS)
Time frame: 3 weeks, 3 months, and 6 months after treatment.
Stability of Interdental Papillary Fill
Time frame: 3 weeks, 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 3 Nov 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Loss of Interdental Papillae
Not yet recruitingPhase 1/2
Clinical Evaluation of Photobiomodulated Hyaluronic Acid Therapy for Interdental Papillary Loss: Minimal Invasive Blind Split Mouth Technique
Interdental Papillae Reconstruction
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium Hydroxylapatite (CaHA) Injectable Filler. and Hyaluronic Acid (HA) Injectable Filler in people with Loss of Interdental Papillae and Black Triangles Syndrome (BTS), run by King Abdulaziz University.
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 4 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: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Black Triangle Area (time frame: Baseline, 3 weeks, 3 months, and 6 months after treatment.). The study lists 2 primary outcomes in all. 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 3 Nov 2026.