Thick vs. Thin Acellular Dermal Matrix (ADM)
ADM
Root Coverage Using the Coronally Positioned Tunnel Technique Comparing Thick Versus Thin Acellular Dermal Matrix
1 other identifier
interventional
22
1 country
1
Brief Summary
To study and compare a thick vs thin acellular dermal matrix for root coverage using the coronally positioned tunnel technique.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 30, 2017
CompletedFirst Submitted
Initial submission to the registry
December 31, 2017
CompletedFirst Posted
Study publicly available on registry
January 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 21, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 21, 2018
CompletedSeptember 10, 2020
September 1, 2020
9 months
December 31, 2017
September 8, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Percent root coverage
Between 0 and 100%
Six months
Secondary Outcomes (1)
Creeping Attachment
Six months
Study Arms (2)
Thin ADM
EXPERIMENTALPeriodontal root coverage surgery using a coronally positioned tunnel and thin acellular dermal matrix (ADM GBR)
Thick ADM
ACTIVE COMPARATORPeriodontal root coverage surgery using coronally positioned tunnel surgery and thick acellular dermal matrix graft (ADM)
Interventions
Eligibility Criteria
You may qualify if:
- A. At least one Miller Class I or II mucogingival defect ≥ 3 mm (Miller 1985). B. The mucogingival defect must be on a non-molar tooth. C. Patients must be ≥ 18 years of age.
You may not qualify if:
- A. Patients with debilitating systemic or diseases that significantly affect the periodontium.
- B. Patients with a known allergy to any of the materials that will be used in the study, including systemic antibiotics (tetracycline and doxycycline).
- C. Patients requiring antibiotic prophylaxis. D. Root surface restorations at the site of recession. E. No detectable CEJ F. Patients who fail to maintain acceptable oral hygiene levels at the test and adjacent teeth.
- G. Patients who are pregnant or lactating. H. Patients who use tobacco products (smoking or smokeless tobacco). I. Patients with alcohol abuse problems. J. Patients undergoing long-term steroid therapy. K. History of previous root coverage procedures, graft or GTR, on the test teeth.
- L. Patients who fail to complete the informed consent form.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Graduate Periodontics, UofL School of Dentistry
Louisville, Kentucky, 40202, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Henry Greenwell
University of Louisville
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Graduate Periodontics
Study Record Dates
First Submitted
December 31, 2017
First Posted
January 5, 2018
Study Start
November 30, 2017
Primary Completion
August 21, 2018
Study Completion
August 21, 2018
Last Updated
September 10, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share