Evaluating injections for reconstructing lost interdental papillae
Clinical Evaluation of Hyaluronic Acid and Platelet Rich Fibrin Injection Efficacy in Interdental Papilla Reconstruction
This study tests whether two different injectable treatments can help fill in gaps between teeth for people who have lost their interdental papillae and see which one works better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Altinbas University Academic / other |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT06314256 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of injectable platelet rich fibrin (i-PRF) and hyaluronic acid (HA) in reconstructing interdental papilla loss, which is a significant aesthetic concern in dental health. Participants with multiple interdental papilla losses will receive both treatments in a split-mouth design, allowing for direct comparison of outcomes. The study will assess how well each treatment closes the gaps known as black triangles and evaluate patient satisfaction with each option. The trial seeks to provide insights into non-surgical methods for improving dental aesthetics and addressing related functional issues.
Who should consider this trial
Good fit: Ideal candidates for this study are systemically healthy individuals with specific types of interdental papilla loss and no recent periodontal treatments.
Not a fit: Patients with systemic health issues, periodontitis, or those who have had recent dental restorations will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with effective non-surgical options for improving dental aesthetics and function.
How similar studies have performed: While there have been various surgical approaches to treat interdental papilla loss, the non-surgical methods being evaluated in this trial are relatively novel and have not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Systemically healthy (without cardiovascular diseases, diabetes, thyroid diseases, auto-immune diseases) * Patients with PPI 2 and PPI 3 papillae according to the Papillary Presence Index classification * Probable pocket depth of 4 mm or less in the relevant area * Plaque index and gingival index in the range of 0-1 * Neighbouring teeth in contact with each other in the relevant area * Absence of any restoration in the relevant area * Non-smoker * No surgical periodontal treatment in the last 6 months * For female subjects not pregnant or lactating * No known allergy to hyaluronic acid Exclusion Criteria: * Not systemically healthy (with cardiovascular diseases, diabetes, thyroid diseases, auto-immune diseases) * Diagnosed with periodontitis * History of allergic reactions to hyaluronic acid * Less than 2 mm keratinized tissue height in the relevant area * Teeth crowding in relevant area * Any kind of restoration (fillings, crowns, etc.) in the relevant area * Smoker * Ongoing orthodontic treatment * Having parafunctional habits (bruxism, etc.)
Where this trial is running
Istanbul
- Altinbas University — Istanbul, Turkey (Recruiting)
Study contacts
- Study coordinator: Baris Impram
- Email: barisimpram@gmail.com
- Phone: +905343148500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.