Back to resultsA Clinical Trial Testing Root Coverage With Acellular Dermal Matrix in Thin and Thick Gingival Biotypes
Primary Purpose
Gingival Recession
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Acellular Dermal Matrix
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession focused on measuring acellular dermal matrix
Eligibility Criteria
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
Sites / Locations
- Tufts University School of Dental Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group 1: Thin Biotype
Group 2: Thick Biotype
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in Clinical Probing Depth (CPD)
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.
Change in Recession Height (RH)
Change in Recession Width (RW)
Change in Keratinized Tissue Width
Change in Gingival Thickness (GT)
Complete Root Coverage (CRC)
CRC will be assessed using descriptive statistics (# subjects with CRC out of the total sample)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03057730
Brief Title
A Clinical Trial Testing Root Coverage With Acellular Dermal Matrix in Thin and Thick Gingival Biotypes
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tufts University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
acellular dermal matrix
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1: Thin Biotype
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2: Thick Biotype
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Acellular Dermal Matrix
Other Intervention Name(s)
Alloderm®
Intervention Description
ADM is a human-derived allograft material, treated to remove all cellular components so that only the connective tissue matrix remains.
Primary Outcome Measure Information:
Title
Change in Mean Root Coverage
Description
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
Secondary Outcome Measure Information:
Title
Change in Clinical Probing Depth (CPD)
Time Frame
Up to 48 months post surgery
Title
Change in Clinical Attachment Level (CAL)
Description
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
Title
Change in Recession Height (RH)
Time Frame
Up to 48 months post surgery
Title
Change in Recession Width (RW)
Time Frame
Up to 48 months post surgery
Title
Change in Keratinized Tissue Width
Time Frame
Up to 48 months post surgery
Title
Change in Gingival Thickness (GT)
Time Frame
Up to 48 months post surgery
Title
Complete Root Coverage (CRC)
Description
CRC will be assessed using descriptive statistics (# subjects with CRC out of the total sample)
Time Frame
Up to 48 months post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wai Cheung, DMD, MS
Organizational Affiliation
Tufts University School of Dental Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts University School of Dental Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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A Clinical Trial Testing Root Coverage With Acellular Dermal Matrix in Thin and Thick Gingival Biotypes
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