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NCT07912294
NA

Comparing Calcium Hydroxylapatite and Hyaluronic Acid for Interdental Papilla Reconstruction

Sponsor: King Abdulaziz University

View on ClinicalTrials.gov

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 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.

Official title: Clinical Evaluation of Hyper-Diluted Calcium Hydroxylapatite Versus Hyaluronic Acid in the Reconstruction of Interdental Papilla Deficiencies: A Split-Mouth Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-11

Completion Date

2028-09

Last Updated

2026-11-03

Healthy Volunteers

No

Interventions

DEVICE

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

Hyaluronic Acid (HA) Injectable Filler

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.