Human Placenta Extract Use in Socket Preservation (NCT06915675) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Human Placenta Extract Use in Socket Preservation
Lebanon10 participantsStarted 2024-08-23
Plain-language summary
This split-mouth pilot study evaluates the effectiveness of flowable decellularized Human Placental Connective Tissue Matrix (HPCTM) in alveolar ridge preservation following tooth extraction. Patients will receive HPCTM mixed with allograft particles in one extraction socket and allograft particles solely in the contralateral socket. The primary outcome is to assess dimensional changes in the alveolar ridge in terms of soft tissue shrinkage using a super-imposed intra-oral scans taken at baseline , day 10, 21 and 30 post-op and bone resorption rate by comparing pre-op and 4 months post-op cone beam computed tomography scans. Secondary outcomes include clinical soft tissue healing evaluation and commentary. The HPCTM used in this study is regulated by the US FDA under Section 361 of the Public Health Service Act (21 CFR Part 1271.10(a)).
Who can participate
Age range
20 Years – 60 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:
* Age ranging between 20 and 60.
* Subjects having two hopeless teeth that needs extraction.
* Teeth fitting in the same morphological category (mono,bi or multirooted).
* Teeth belonging to different arch quadrants.
* Presence of more than half of the socket bone housing.
* Non-smoking patient.
Exclusion Criteria:
* Presence of active periodontal diseases i.e Miller class II and above categories.
* Presence of heavy metallic artefacts that can distort CBCT scans.
* Bad oral hygiene and non-compliance.
* Systemic diseases interfering with bone metabolism.
* Pregnant or lactating women.
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
Soft tisse shrinakge at different time points of the test and control groups