CompletedPhase 2

Comparison of Amnion Chorion Membrane vs. Dense Polytetrafluoroethylene Membrane in Ridge Preservation Procedures

9 participantsStarted 2012-09

Plain-language summary

The purpose of this study is to examine if a biologically active commercially available amnion chorion membrane (ACM) is as effective as the commercially available inert dense polytetrafluoroethylene membrane (D-PTFE) in preserving jaw bone dimensions and whether it provides the added benefit of reducing post-operative discomfort after dental surgery

Who can participate

Age range

18 Years – 75 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 needing bilateral non-molar dental extractions in the same arch and consenting to a 2nd surgery for core-biopsy participated in the study. Subjects were required to be within the American Academy of Anesthesiologists (ASA) classifications ASA I or ASA II. Males between 18-75 years and females between 18-50 years of age were screened. Exclusion Criteria: * inability or anticipated failure to maintain adequate oral hygiene; evidence of active periodontitis; pregnant or breastfeeding mothers, unstable systemic diseases or with compromised immune system (e.g., uncontrolled diabetes, etc.) or unstable bleeding disorders; active infectious diseases (e.g., hepatitis, tuberculosis, HIV, etc.); mental disabilities that may hinder participation; active immunosuppressive therapy, cancer therapy and/or radiation to the oral cavity within last 6-months; conditions/medications contraindicated for bone regeneration (e.g., methotrexate, steroids, bisphosphonates, cyclosporin-A), and and self-reported tobacco usage (equivalent to \>20 cigarettes per day).

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

Amount of Preservation of Alveolar Ridge Dimensions i.e..,Clinical Horizontal Ridge Width Change in Millimeter as Result of Ridge Preservation Procedures

Timeframe: 3-4 months

Evaluation of Preservation of Ridge Quality Through Microtomographic Analysis for Microarchitectural Parameters Expressed as Percentages.

Timeframe: 3-4 month

Evaluation of Preservation of Ridge Quality Through Histological Analysis for Microarchitectural Parameters Expressed as Percentages.

Timeframe: 3-4 months

Post Operative Pain

Timeframe: 0-2 weeks

Amount of Preservation of Alveolar Ridge Dimensions Following Ridge Preservation Procedures i.e., Horizontal Ridge Width Height Change in Millimeters as Assessed Through Analysis of CBCT Scans.

Timeframe: 3-4 months

Amount of Preservation of Alveolar Ridge Dimensions Following Ridge Preservation Procedures i.e., Vertical Ridge Height Change in Millimeters as Assessed Through Analysis of CBCT Scans.

Timeframe: 3-4 months

Trial details

NCT IDNCT02602223

SponsorIndiana University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-07

Results submitted2016-04-15

View on ClinicalTrials.gov More Alveolar Bone Loss trials

Plain-language summary

Who can participate

Age range

18 Years – 75 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.

What they're measuring

Amount of Preservation of Alveolar Ridge Dimensions i.e..,Clinical Horizontal Ridge Width Change in Millimeter as Result of Ridge Preservation Procedures

Timeframe: 3-4 months

Evaluation of Preservation of Ridge Quality Through Microtomographic Analysis for Microarchitectural Parameters Expressed as Percentages.

Timeframe: 3-4 month

Evaluation of Preservation of Ridge Quality Through Histological Analysis for Microarchitectural Parameters Expressed as Percentages.

Timeframe: 3-4 months

Post Operative Pain

Timeframe: 0-2 weeks

Amount of Preservation of Alveolar Ridge Dimensions Following Ridge Preservation Procedures i.e., Horizontal Ridge Width Height Change in Millimeters as Assessed Through Analysis of CBCT Scans.

Timeframe: 3-4 months

Amount of Preservation of Alveolar Ridge Dimensions Following Ridge Preservation Procedures i.e., Vertical Ridge Height Change in Millimeters as Assessed Through Analysis of CBCT Scans.

Timeframe: 3-4 months