Root Coverage Comparing Suturing Techniques
Root Coverage With Acellular Dermal Matrix Using the Coronally Positioned Tunnel Technique Comparing Two Different Suturing Techniques.
1 other identifier
interventional
16
1 country
1
Brief Summary
The hypothesis of this study is that coronally positioned tunnel with acellular dermal matrix using a continuous sling suture to secure both the graft and the flap will result in better percent root coverage compared to the continuous sling suturing technique to secure the graft and the flap separately.
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 Sep 2013
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
First Submitted
Initial submission to the registry
July 12, 2013
CompletedFirst Posted
Study publicly available on registry
July 17, 2013
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedDecember 8, 2016
December 1, 2016
10 months
July 12, 2013
December 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent root coverage
The amount of root coverage will be measured and converted to a percent.
6 months
Study Arms (2)
Sutured separately
ACTIVE COMPARATORThe soft tissue and the allograft will each be sutured separately using a continuous sling suture.
Sutured together
EXPERIMENTALThe soft tissue and the allograft will be sutured together using a continuous sling suture.
Interventions
The soft tissue and the allograft will be sutured together using a continuous sling suture.
The soft tissue and the allograft will be sutured separately using a continuous sling suture.
Eligibility Criteria
You may qualify if:
- At least one Miller Class I or II mucogingival defect ≥ 3 mm (Miller 1985).
- The mucogingival defect must be on a non-molar tooth.
- Patients must be between ≥ 18 years of age.
You may not qualify if:
- Patients with a known allergy to any of the materials that will be used in the study, including systemic antibiotics (tetracycline and doxycycline).
- Patients requiring antibiotic prophylaxis.
- Root surface restorations at the site of recession.
- No detectable cemento-enamel junction.
- Patients who fail to maintain oral hygiene levels of at least 80% plaque free surfaces.
- Patients who are pregnant or lactating.
- Patients who use tobacco products (smoking or smokeless tobacco).
- Patients with alcohol abuse problems.
- Patients undergoing long-term steroid therapy.
- History of previous root coverage procedures, graft or guided tissue regeneration, on the test teeth.
- Patients who fail to complete the informed consent form.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Graduate Periodontics Clinic University of Louisville
Louisville, Kentucky, 40202, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Henry Greenwell, DMD
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
- Professor
Study Record Dates
First Submitted
July 12, 2013
First Posted
July 17, 2013
Study Start
September 1, 2013
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
December 8, 2016
Record last verified: 2016-12