← Back to all trials
Not Yet Recruiting
NCT07912294
Comparing Calcium Hydroxylapatite and Hyaluronic Acid for Interdental Papilla Reconstruction
Conditions: Loss of Interdental Papillae, Black Triangles Syndrome (BTS)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 20
Sponsor: King Abdulaziz University
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.
Eligibility Criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Patients with chronic systemic diseases.
* Pregnant or lactating women.
* Current smokers.
* Children and adolescents under 18 years of age.
Source: ClinicalTrials.gov (NCT07912294). StuddyBuddy aggregates publicly available trial information.