A Comparative Clinical Study Between a Collagen Matrix and Collagen Membrane as Wound Protection … (NCT06029322) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Comparative Clinical Study Between a Collagen Matrix and Collagen Membrane as Wound Protection During Ridge Preservation ARP
Belgium18 participantsStarted 2024-01-02
Plain-language summary
Patients in need of extraction of two teeth in combination with alveolar ridge preservation will be invited to participate in intra-subject RCT on ARP. Prior to surgery, a small-field low-dose CBCT is taken.
18 patients will be included, each contributing 1 surgical site to each treatment arm.
Since this study is a intra-subject RCT randomization of the surgical site will be performed just after ARP by a coin flip. Randomization is concealed for the evaluating examiner and statistician.
After ARP the collagen matrix or collagen membrane is used to seal the coronal aspect of the extraction socket.
Soft tissue thickness in centre of the site will be determined using CBCT. Secondary outcomes include: Wound dimensions, socket wound healing score, changes in bone and soft tissue dimensions and changes in buccal soft tissue profile
Who can participate
Age range
21 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:
* At least 21 years old
* Good oral hygiene defined as a full-mouth plaque score ≤ 25% (O'Leary, Drake, \& Naylor, 1972)
* Need for ARP after tooth extraction at two sites in the maxilla or mandible with \> 50% buccal bone present following tooth extraction
* Signed informed consent
Exclusion Criteria:
* Any systemic disease
* Pregnancy
* Smoking (will be specifically asked)
* Untreated periodontitis
* Untreated caries lesions
* Suppuration and/or active infection around the failing tooth
* Midfacial recession at the failing tooth
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.