Efficacy of Volume Stable Collagen Matrix in Interdental Papilla Reconstruction in Maxillary Esth… (NCT05576441) | Clinical Trial Compass
UnknownNot Applicable
Efficacy of Volume Stable Collagen Matrix in Interdental Papilla Reconstruction in Maxillary Esthetic Region
India36 participantsStarted 2022-11-05
Plain-language summary
: Interdental papilla deficiency leads to food impaction, problems with phonetics and an unaesthetic appearance. Reconstruction of the deficient papilla is therefore, important. The purpose of study is to compare the VCMX and SCTG in papillae reconstruction. The null hypothesis is that there is no significant difference in clinical outcome for interdental papilla regeneration by volume stable collagen matrix and subepithelial connective tissue graft.
Who can participate
Age range
18 Years – 55 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:
* Patients in the age range of 18-55 years who are systemically healthy.
* Patients with class II papillary recession according to Norland and Tarnow's classification and radiographically,the distance between contact point(CP) to alveolar crest ≤ 6mm.
* Patients who have completed etiological periodontal therapy(full mouth scaling and root planning)with Plaque index(Silness and Loe)\<1,gingival index(Loe and silness)\<1 and showing adequate compliance and willing to participate in the study.
* Patient complains of food lodgement or esthetic consideration for open gingival embrasure
Exclusion Criteria:
* Patients with the history of uncontrolled hypertension, diabetes,hyperthyroidism and on medications that influence the outcome of periodontal therapy.
* Presence of open contacts in the maxillary anterior region.
* Presence of crowding in the maxillary anterior region.
* Pregnant and lactating women.
* Patients with active periodontal disease
* Smokers,tobacco users
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
Gain in papillary height
Timeframe: 6 months
Trial details
NCT IDNCT05576441
SponsorPostgraduate Institute of Dental Sciences Rohtak