A Phase 4 interventional study of Acellular Dermal Matrix in Gingival Recession, sponsored by Tufts University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-20.
Sponsored by Tufts University · Phase 4, Interventional, and Treatment
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.
The study aim is to evaluate and compare the use of acellular dermal matrix, a material used for treating gum recession, in two study populations, namely thin or thick gingival biotype. Short term outcomes and the long term stability of ADM in recession repair between thick and thin biotypes will be evaluated.
There will be two study groups, namely thin and thick groups. The included subjects will be divided in two groups according to gingival thickness: Thin gingival biotype group (TnB): \< 0.8 mm, thick gingival biotype group (TkB) ≥ 0.8 mm. Each subject will be in one of the two groups only.
Randomization will not be used to assign the subjects to the study groups, because the intervention will be the same for both groups, namely ADM applied beneath a coronally advanced flap.
The short term (3 months, 6 months post-surgery) outcomes and the longer term (12 months, 24 months and 48 months post-surgery) outcomes will further be compared within the groups and between the groups.
402 studies on the registry are indexed under Gingival Recession; 98 are open to participants now.
This study's enrollment of 34 is above the median of 30 across 368 interventional studies indexed under Gingival Recession.
Browse Gingival Recession studies →Tufts University is the lead sponsor of 225 studies on the registry; 24 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Gingival thickness \< 0.8 mm Acellular Dermal Matrix (ADM) will be used according to manufacturer's instructions during mucogingival surgery. Subjects will be anesthetized using local anesthesia. An envelope flap design will be involved with no releasing incisions. The ADM will be placed beneath the flap. The flap will then be advanced to the level of cemento-enamel junction (CEJ). The area will be sutured. Mean root coverage, CPD, CAL, RH, RW, KTW, GT, and CRC will be measured and compared at 3 months, 6 months, 12 months, 24 months and 48 months post-surgery.
Biological: Acellular Dermal Matrix
Gingival thickness ≥ 0.8 mm Acellular Dermal Matrix (ADM) will be used according to manufacturer's instructions during mucogingival surgery. Subjects will be anesthetized using local anesthesia. An envelope flap design will be involved with no releasing incisions. The ADM will be placed beneath the flap. The flap will then be advanced to the level of cemento-enamel junction (CEJ). The area will be sutured. Mean root coverage, CPD, CAL, RH, RW, KTW, GT, and CRC will be measured and compared at 3 months, 6 months, 12 months, 24 months and 48 months post-surgery.
Biological: Acellular Dermal Matrix
ADM is a human-derived allograft material, treated to remove all cellular components so that only the connective tissue matrix remains.
Also known as: Alloderm®
Change in Mean Root Coverage
Root coverage will be measured in mm using a probe and digital caliper. Mean root coverage will be measured per patient by averaging the two study teeth. Change in mean root coverage for the primary outcome will be assessed by the difference between the baseline mean root coverage and the final mean root coverage at 48 months post surgery.
Time frame: Up to 48 months post surgery
Change in Clinical Probing Depth (CPD)
Time frame: Up to 48 months post surgery
Change in Clinical Attachment Level (CAL)
CAL will be measured from the base of the pocket to the cementoenamel junction (CEJ) in mm using a probe and digital caliper. Change in CAL will be assessed from baseline to 48 months post surgery.
Time frame: Up to 48 months post surgery
Change in Recession Height (RH)
Time frame: Up to 48 months post surgery
Change in Recession Width (RW)
Time frame: Up to 48 months post surgery
Change in Keratinized Tissue Width
Time frame: Up to 48 months post surgery
Change in Gingival Thickness (GT)
Time frame: Up to 48 months post surgery
Complete Root Coverage (CRC)
CRC will be assessed using descriptive statistics (# subjects with CRC out of the total sample)
Time frame: Up to 48 months post surgery
Plan to share: No
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This study is active, not recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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