The Clinical Effects of Using Collagen Matrix in Papilla Augmentation: a Prospective Clinical Tri… (NCT06853704) | Clinical Trial Compass
CompletedPhase 2/3
The Clinical Effects of Using Collagen Matrix in Papilla Augmentation: a Prospective Clinical Trial. Augmenting Fibro-Gide in Interdental Area Using Tunneling Technique to Treat Black Triangles (Papilla Loss)
Jordan8 participantsStarted 2023-06-15
Plain-language summary
Black triangles, also known as open gingival embrasures, are usually the result of the lack of papilla fill interdentally. With the improvement of dental procedures and materials, more attention has been directed to improving this unesthetic occurrence. Improvement of papilla loss (black triangle) can be mainly categorized into non-surgical and surgical techniques with most surgical modalities focused on a minimally invasive approach due to the restricted working area and blood supply to the papilla. Collagen matrix offers strong mechanical properties while promoting tissue healing and hence is used in many periodontal plastic surgeries (gum surgeries). However, the outcome of collagen matrix in treating papilla loss has not been studied yet. This study aimed to see at the clinical effects of collagen matrix in papilla augmentation using a minimally invasive surgical approach.
Patients with papillae loss were selected and Collagen matrix (Geistlich Fibro-Gide) used to stabilize the affected area with a minimally invasive surgical procedure. Papilla height gain, texture and color will be assessed pre-operatively, three and six months postoperatively. in addition, probing depth, clinical attachment level and keratinized tissue width will also be assessed.
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
* Male and female patients above the age of 18 years old with papilla loss.
* papilla loss between 2 natural teeth.
* Absence of active periodontal disease.
* Patients willing to follow oral hygiene measures.
* At least one papillary recession in the maxilla from UR5 to UL5.
* Papillay recession classified as 1 or 2 according to Nordland and Tarnow classification 1998.
* Sites with less than 7 mm measurement from the contact point to the bone crest.
* Sites having adequate width of attached gingiva(\>2mm).
Exclusion Criteria
* Patients with incorrect crown or restoration margins, and/or caries.
* Patients undergoing orthodontic treatment.
* Patients who consume alchohol/smoking .
* Papilla loss around dental implant.
* Patients with any systemic disease that may compromise or affect the results of the surgical procedure.
* Breast feeding or pregnant woman.
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.