Back to resultsOrACELL™ vs. Connective Tissue in Miller Class 3 Defects
Primary Purpose
Gingival Recession
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
OrACELL
Connective Tissue Graft
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession focused on measuring Gingival Recession, Connective Tissue Graft, OrACELL, Decellularized Dermis, Periodontics
Eligibility Criteria
Inclusion Criteria:
- Patients must be between 18 and 80 years old, with recession present in one quadrant as either single or multiple buccal vertical recession sites
- The defect must be at least 2mm in length, (measured from the CEJ to the midfacial gingival margin) and classified as either Miller Class I, II or III
- Study is limited to vital and nonvital incisors, canines, and premolars
- If teeth adjacent to the site to be treated had recession as well, they were included in the grafting procedure but not included in measurement
- Plaque control defined as modified O'Leary Index of 85% was established before surgical intervention
- Only sites with probing depths of 3mm or less and no bleeding on probing were accepted for surgery
Exclusion Criteria:
- Subjects who smoke more than ten cigarettes per day or use nicotine replacement therapy
- History of previous history of surgery performed at surgical sites included in study
- Subjects who have uncontrolled or poorly controlled systemic conditions that could compromise or contraindicate periodontal surgery
- Non-English speakers
- Pregnant or lactating females
- Immunosuppressant medications
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Connective Tissue Graft
OrACELL
Arm Description
Connective Tissue is harvested from the palate of the subject then placed over the recession defect on the facial of the designated tooth. A coronally advanced flap is raised to cover the connective tissue graft and the recession.
Allograft Tissue (human dermis) is removed from packing and placed over the recession defect on the facial of the designated tooth. A coronally advanced flap is raised to cover the OrACELL graft and the recession.
Outcomes
Primary Outcome Measures
Gingival Recession (Root Coverage)
The measurement in millimeters of the relationship of the cementoenamel junction (CEJ) to the gingival margin
Secondary Outcome Measures
Full Information
NCT ID
NCT03226600
First Posted
May 31, 2017
Last Updated
July 20, 2017
Sponsor
Texas A&M University
Collaborators
LifeNet Health
1. Study Identification
Unique Protocol Identification Number
NCT03226600
Brief Title
OrACELL™ vs. Connective Tissue in Miller Class 3 Defects
Official Title
A COMPARATIVE STUDY OF ROOT COVERAGE USING OrACELL™ VERSUS SUBEPITHELIAL CONNECTIVE TISSUE GRAFT: A RANDOMIZED CONTROLLED TRIAL
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 26, 2015 (Actual)
Primary Completion Date
June 13, 2016 (Actual)
Study Completion Date
December 16, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas A&M University
Collaborators
LifeNet Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose was to compare root coverage outcomes between autogenous connective tissue graft (CTG) and decellularized human dermis (OrACELL™) in areas of facial gingival recession.
Detailed Description
Twenty-four non-smoking, healthy patients, with 2mm or greater facial gingival recession at a minimum of one site that classified as a Miller Class I, II, or III recession defect were included. Patients were randomly assigned to either control (CTG) or OrACELL™ (test) groups, which were treated with identical surgical techniques. All root coverage clinical parameters were evaluated at baseline, 3-, and 6-months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
Gingival Recession, Connective Tissue Graft, OrACELL, Decellularized Dermis, Periodontics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial between two treatment modalities for gingival recession with 6 month follow-up
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Connective Tissue Graft
Arm Type
Active Comparator
Arm Description
Connective Tissue is harvested from the palate of the subject then placed over the recession defect on the facial of the designated tooth. A coronally advanced flap is raised to cover the connective tissue graft and the recession.
Arm Title
OrACELL
Arm Type
Experimental
Arm Description
Allograft Tissue (human dermis) is removed from packing and placed over the recession defect on the facial of the designated tooth. A coronally advanced flap is raised to cover the OrACELL graft and the recession.
Intervention Type
Device
Intervention Name(s)
OrACELL
Intervention Description
OrACELL is human dermis that undergoes the MATRACELL process. MATRACELL is a patented and validated process that renders allograft tissue acellular, without compromising the biomechanical or desired biochemical properties of an allograft bio-implant for its intended surgical application.
Intervention Type
Device
Intervention Name(s)
Connective Tissue Graft
Other Intervention Name(s)
Subepithelial Connective Tissue Graft
Intervention Description
A measured layer of dermis is surgically removed from the palate for use as a graft to cover gingival recession
Primary Outcome Measure Information:
Title
Gingival Recession (Root Coverage)
Description
The measurement in millimeters of the relationship of the cementoenamel junction (CEJ) to the gingival margin
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients must be between 18 and 80 years old, with recession present in one quadrant as either single or multiple buccal vertical recession sites
The defect must be at least 2mm in length, (measured from the CEJ to the midfacial gingival margin) and classified as either Miller Class I, II or III
Study is limited to vital and nonvital incisors, canines, and premolars
If teeth adjacent to the site to be treated had recession as well, they were included in the grafting procedure but not included in measurement
Plaque control defined as modified O'Leary Index of 85% was established before surgical intervention
Only sites with probing depths of 3mm or less and no bleeding on probing were accepted for surgery
Exclusion Criteria:
Subjects who smoke more than ten cigarettes per day or use nicotine replacement therapy
History of previous history of surgery performed at surgical sites included in study
Subjects who have uncontrolled or poorly controlled systemic conditions that could compromise or contraindicate periodontal surgery
Non-English speakers
Pregnant or lactating females
Immunosuppressant medications
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
OrACELL™ vs. Connective Tissue in Miller Class 3 Defects
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