Clinical Evaluation of Interdental Papilla Reconstruction Using Injectable Autogenous Fat Versus … (NCT05579522) | Clinical Trial Compass
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Clinical Evaluation of Interdental Papilla Reconstruction Using Injectable Autogenous Fat Versus Hyaluronic Acid Filler.
20 participantsStarted 2022-10-10
Plain-language summary
The goal of this randomized controlled trial is to evaluate the amount of interdental papilla fill following the injection of the fat graft compared to hyaluronic acid filler in patients with interdental papilla deficiency. Highly motivated patients having at least one deficient papilla with the presence of a contact point between adjacent teeth in the inter-bicuspid region. Papillary deficiency types I or II, according to Nordland and Tarnow (1998)classification will be selected. The main question it aims to answer is: In patient with interdental papillary deficiency, will injecting autogenous fat increase papilla height compared to hyaluronic acid injection? Participants in the test group will receive fat graft injection in the inter dental papilla. In the injection phase, 3 injections will be given at each papilla site: at baseline, 3 and 6 weeks intervals. While in the control group, hyaluronic acid injection in the interdental papilla and also 3 injections will be given at each papilla site at the same intervals.
Who can participate
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:
* Highly motivated patients having at least one deficient papilla in the inter-bicuspid region.
* Papillary deficiency types I or II, according to Nordland and Tarnow classification \[13\]
* No radiographic evidence of bone loss interproximally. (Cardaropoli et al,2004)
* Full mouth plaque index (PI) and gingival index (GI) scores should be less than 20%.
* No open contacts between affected teeth should be present.
* Teeth free from caries, proximal restorations, fixed prosthesis or orthodontic appliances
Exclusion Criteria:
* Subjects with medical conditions that may affect periodontal healing or regeneration.
* Subjects with a history of allergic reactions, smokers, and alcoholics
* Pregnant or breastfeeding females
* Patients with current or previous drugs intake that may predispose to gingival enlargement.
* Patients under orthodontic treatment or had orthodontic treatment in the past six months
* Patients with a history of periodontal surgeries over the last six months at the area of interest
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
1
change in Black Triangle Height (BTH)
Timeframe: Specific measurement time point: at baseline and after 6 months postoperatively.