Comparison of Freeze-Dried Amniotic and Collagen Membranes for Soft Tissue Healing After Grafted … (NCT07647120) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Freeze-Dried Amniotic and Collagen Membranes for Soft Tissue Healing After Grafted Implant Surgery
India10 participantsStarted 2025-06-19
Plain-language summary
The goal of this clinical trial is to learn whether Freeze-Dried Amniotic Membrane (FD-AM) or Collagen Membrane (CM) provides better soft tissue healing after Stage I dental implant surgery with particulate bone grafting in adults requiring implant treatment in bilateral posterior maxillary edentulous sites. It will also evaluate postoperative pain associated with the two membrane types.
The main questions it aims to answer are:
Does FD-AM result in improved early soft tissue healing compared with CM as assessed by the Early Healing Score (EHS)? Does FD-AM reduce postoperative pain compared with CM as assessed by the Visual Analogue Scale (VAS)?
Researchers will compare FD-AM and CM placed over grafted implant sites to determine whether one membrane provides superior healing outcomes and patient comfort.
Participants will:
Undergo Stage I implant surgery with particulate bone grafting. Receive FD-AM at one implant site and CM at the contralateral implant site according to the study randomization protocol.
Attend follow-up visits for assessment of soft tissue healing and postoperative pain.
Complete questionnaires related to pain and healing outcomes during the postoperative period.
Who can participate
Age range
25 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:
* Adults aged 25-55 years.
* Male and female participants.
* Bilateral posterior maxillary edentulous area in the premolar region (Bedrossian Zone 2 classification).
* Patients with teeth requiring extraction and eligible for immediate implant placement in the bilateral posterior maxillary region.
* Patients with ridge defects classified as Siebert Class II or Class III and eligible for delayed implant placement in the bilateral posterior maxillary region.
Exclusion Criteria:
* Current smokers.
* History of systemic diseases affecting bone turnover, including hyperthyroidism (T4 outside 5.0-12.0 μg/dL or T3 outside 80-220 ng/dL), Type I diabetes mellitus (HbA1c \> 6%), Cushing's disease, or hyperlipidemia.
* Pregnant women.
* Lactating mothers.
* Presence of periodontal disease.
* Known allergy to study materials or medications.
* Blood-borne infectious diseases, including HIV or HBsAg positivity.
* Vitamin D level \< 30 ng/mL.
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.