Connective Tissue Grafting for Single Tooth Recession Defects & the Impact of the Thickness of the Palatal Harvest Tissue: A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Columbia University
- Enrollment
- 42
- Primary Endpoint
- Root coverage
Study Overview
Brief Summary
The purpose of this study is to test if the thickness of the graft taken from the roof of the mouth, has a significant effect on the amount of attached tissue and the amount of root coverage that are attained when treating a single tooth with gingival recession.
Detailed Description
The goal of the study is to determine if the thickness of a tissue graft taken from the roof of the mouth, used to cover the exposed root of a tooth, affects the overall outcome of the root coverage, the health of the resulting tissue, as well as postoperative pain as reported by the patient. Connective tissue grafts will be harvested in different thicknesses, and results of the procedures will be compared. Qualified subjects will undergo a root coverage procedure, after random assignment to one of the groups. Regular recall visits to monitor healing at intervals of 1 week, 2 weeks, 1 month, and 3 months will be scheduled. Subjects will be asked to fill out patient response forms regarding pain and other symptoms at these visits. Photographs will be taken.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age>18 years old
- •Absence of active periodontal disease
- •Single tooth (premolars and anterior teeth) with Miller class I or II gingival recession >= 2mm
- •Detectable Cemento-Enamel Junction (CEJ) -
Exclusion Criteria
- •Smokers (>10 cigarettes/ per day)
- •Uncontrolled systemic diseases with compromised healing potential (DM with HbA1c >7%)
- •Active infectious diseases (hepatitis, tuberculosis, HIV, etc.)
- •Medication known to cause gingival enlargement
- •Patients taking anticoagulants with an international normalized ratio (INR) >2.5
- •Long-term (>2 weeks) use of antibiotics in the past 3 months
- •Pregnant or attempting to get pregnant
- •Sites with probing depth > 4mm
- •Recession adjacent to an edentulous area
- •Frenal and muscle attachment that encroach on the marginal gingiva
- •a. Can be included 2 months after surgical therapy to remove the frenum (frenectomy)
- •History of periodontal surgical treatment of the involved sites
- •Prosthetic crown, restorations or caries in the candidate tooth and adjacent teeth
- •Teeth with pulpal pathology
- •Severe teeth malposition and open contacts
- •Planned orthodontic treatment to commence within 1 year following procedure
- •Parafunctional habits -
Arms & Interventions
2mm thick graft
connective tissue graft of 2mm thickness
Intervention: connective tissue graft (Procedure)
1mm thick graft
connective tissue graft of 1mm thickness
Intervention: connective tissue graft (Procedure)
Outcomes
Primary Outcomes
Root coverage
Time Frame: Upto 3 months
Amount of root coverage attained in millimeters
width of keratinized tissue
Time Frame: Upto 3 months
Amount of zone of keratinized tissue attained in millimeters
Secondary Outcomes
- duration of erythema and edema(Upto 3 months)
- amount of erythema and edema(Upto 3 months)
- thickness of keratinized tissue(Upto 3 months)
Investigators
Evanthia Lalla
Professor of Dental Medicine (Periodontics)
Columbia University