Alveolar Ridge Preservation Following Tooth Extraction.
United States47 participantsStarted 2022-08-15
Plain-language summary
Bone resorption after a tooth extraction is a generally accepted knowledge and has been demonstrated by many animal and human studies. Especially during the first three months followed by the tooth extraction, the volume of bone may change significantly without any interference. Thus, doing a ridge preservation procedure following the extraction is a common standard of care method to maintain the socket volume if implant placement is considered as a treatment option in the future. A variety of materials and methods have been used for ridge preservation. However, it's still inconclusive to determine the best material to maintain the ridge dimension, especially for membrane placement that allows for space maintenance to protect the grafting material. Furthermore, there is no evidence to show any treatment rationale is superior to any other ridge preservation method.
In general, the membrane serves the function of the barrier and space protector. The periodontal surgeon use membranes to exclude the epithelium growth and to limit the collapse of the soft tissue into the healing alveolar socket. Regarding resorbable and non-resorbable membrane materials, both serve the function of protecting the graft material from the oral cavity. However, there are also many demonstrating that without membranes the extraction socket healed nicely without any interferences. The question to us is: Do we need the membrane to exclude the epithelium or any kind of surgical dressing material is sufficient enough to preserve the volume of the extracted ridge?
The object of this study is to compare five popular membranes on the market that present different characteristics of the membranes.
Who can participate
Age range
18 Years – 80 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:
* Subjects must between the ages of 18 and 80.
* Subjects must require removal of at least one maxillary premolar
* Subjects should benefit from an implant-supported crown.
* Subjects must have voluntarily signed the informed consent form.
* Subjects must be assessed as ASA I, ASA II by a member of the research team.
Exclusion Criteria:
* Medical conditions requiring the use of steroids.
* History of leukocyte dysfunction or deficiencies, bleeding deficiencies, renal failure, uncontrolled endocrine disorders, acquired immunodeficiency syndrome or hepatitis.
* History of neoplastic disease requiring the use of chemotherapy or irradiation to head and neck.
* Subjects who have diabetes mellitus.
* Subjects who have undergone administration of any investigational drug or device within 30 days of enrollment in the study.
* Alcohol or drug abuse.
* Subjects who are heavy smokers (greater than 10 cigarettes per day or cigar equivalents) or chew tobacco.
* Conditions or circumstances, in the opinion of the research team, which would prevent completion of study participation or interfere with analysis of study results, such as a history of non-compliance or unreliability.
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
Ridge dimension changes before and after the augmentation.
Timeframe: from the date of the extraction 4 months