A Clinical Trial Testing Root Coverage With Acellular Dermal Matrix in Thin and Thick Gingival Bi… (NCT03057730) | Clinical Trial Compass
Active — Not RecruitingPhase 4
A Clinical Trial Testing Root Coverage With Acellular Dermal Matrix in Thin and Thick Gingival Biotypes
United States34 participantsStarted 2015-08
Plain-language summary
Gingival recession is a common defect among the American population. It is also a major cause for root decay, hypersensitivity, contributes to tooth mobility and low self-esteem. Acellular dermal matrix, a human-derived grafting material has been put on the market for the treatment of gingival recession. Treating gingival recession with this material has been a validated treatment option for years.
However, treatment outcomes in two patient populations, namely those with thin biotypes and those with thick biotypes, has not been investigated. This study will observe the primary treatment outcomes in the two patient groups at 5 time points - 3 months, 6 months and 12 months post-surgery to observe short term outcomes; additional 24 months and 48 months post-surgery to observe long term outcomes.
Who can participate
Age range
18 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 be current patients of Tufts University School of Dental Medicine
* Subjects with two Miller class I or class II adjacent recessions with a recession height ≥ 2 mm and \< 4 mm
* Affected tooth/teeth are anterior- incisors, canines or premolars (except the mandibular central and lateral incisors)
* Healthy subjects with no contraindications to root coverage surgery
* Subjects with full-mouth plaque index\<1 and gingival index\<1, calculated as the average value of plaque index and gingival index
Exclusion Criteria:
* Presence of adjacent defects, whose gingival thickness values place them in a different category other than thick or thin biotype
* Areas that have previously been treated with root coverage surgeries
* Subjects with a known hypersensitivity to polysorbate 20 (contraindicated with the use of Alloderm®)
* Subject smokes more than 5 cigarettes per day
* Subjects with systemic conditions which influence wound healing
* Subjects that are pregnant or lactating
* Subjects with a condition causing immunosuppression, or currently taking immunosuppressant medications
* Teeth with severe occlusal interferences, deep cervical lesions, or large restorations whose margins impinge on the cement-enamel junction or make identification of this landmark impossible
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.