A Clinical Trial Testing Root Coverage With Acellular Dermal Matrix in Thin and Thick Gingival Biotypes
| Status: | Recruiting |
|---|---|
| Conditions: | Dental |
| Therapuetic Areas: | Dental / Maxillofacial Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/14/2019 |
| Start Date: | August 2015 |
| End Date: | August 2021 |
| Contact: | Wai Cheung |
| Email: | Wai.Cheung@tufts.edu |
| Phone: | (617) 636-6659 |
Acellular Dermal Matrix Combined With Coronally Advanced Flap in the Treatment of Multiple Recession Defects in Thin Versus Thick Periodontal Biotype Population: A Controlled Clinical Investigation
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.
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.
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.
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
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