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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Thin Biotype | Experimental | 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. |
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| Group 2: Thick Biotype | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acellular Dermal Matrix | Biological | ADM is a human-derived allograft material, treated to remove all cellular components so that only the connective tissue matrix remains. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 48 months post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinical Probing Depth (CPD) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wai Cheung, DMD, MS | Tufts University School of Dental Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts University School of Dental Medicine | Boston | Massachusetts | 02111 | United States |
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| ID | Term |
|---|---|
| D005889 | Gingival Recession |
| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C440568 | Alloderm |
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|
| Up to 48 months post surgery |
| Change in Recession Height (RH) | Up to 48 months post surgery |
| Change in Recession Width (RW) | Up to 48 months post surgery |
| Change in Keratinized Tissue Width | Up to 48 months post surgery |
| Change in Gingival Thickness (GT) | 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) | Up to 48 months post surgery |
| D055093 |
| Periodontal Atrophy |