CompletedPhase 4

Clinical Evaluation of Hyaluronic Acid and Platelet Rich Fibrin Injection Efficacy in Interdental Papilla Reconstruction

Turkey (Türkiye)13 participantsStarted 2024-04-10

Plain-language summary

The goal of this clinical trial is to evaluate and compare the efficacy of injectable platelet rich fibrin (i-PRF) and hyaluronic acid (HA) in reconstruction of interdental papilla loss. The main questions it aims to answer are: * How compareable are above mentioned two interventions (i-PRF\&HA) in reconstruction of interdental papilla loss? * Which treatment option is better accepted by patients? Which treatment option would patients be more satisfied with? Participants with multiple interdental papilla loss will be treated with both i-PRF and HA in split-mouth design. Researchers will compare two treatment options to see if black triangles caused by interdental papilla loss closes and if yes, for how long do they last.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Black Triangle Area

Timeframe: After the last injection: 1 month - 3 months

Intedental Papilla Reconstruction Rate

Timeframe: After the last injection: 1 month - 3 months

Trial details

NCT IDNCT06314256

SponsorAltinbas University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-01

View on ClinicalTrials.gov More Interdental Papilla Loss trials