Gingival Recession
Conditions
Keywords
Gingival Recession
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.
Interventions
PROCEDUREconnective tissue graft
palatal connective tissue graft to attain root coverage
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age\>18 years old 2. Absence of active periodontal disease 3. Single tooth (premolars and anterior teeth) with Miller class I or II gingival recession \>= 2mm 4. Detectable Cemento-Enamel Junction (CEJ) -
Exclusion criteria
1. Smokers (\>10 cigarettes/ per day) 2. Uncontrolled systemic diseases with compromised healing potential (DM with HbA1c \>7%) 3. Active infectious diseases (hepatitis, tuberculosis, HIV, etc.) 4. Medication known to cause gingival enlargement 5. Patients taking anticoagulants with an international normalized ratio (INR) \>2.5 6. Long-term (\>2 weeks) use of antibiotics in the past 3 months 7. Pregnant or attempting to get pregnant 8. Sites with probing depth \> 4mm 9. Recession adjacent to an edentulous area 10. Frenal and muscle attachment that encroach on the marginal gingiva a. Can be included 2 months after surgical therapy to remove the frenum (frenectomy) 11. History of periodontal surgical treatment of the involved sites 12. Prosthetic crown, restorations or caries in the candidate tooth and adjacent teeth 13. Teeth with pulpal pathology 14. Severe teeth malposition and open contacts 15. Planned orthodontic treatment to commence within 1 year following procedure 16. Parafunctional habits -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Root coverage | Upto 3 months | Amount of root coverage attained in millimeters |
| width of keratinized tissue | Upto 3 months | Amount of zone of keratinized tissue attained in millimeters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| thickness of keratinized tissue | Upto 3 months | — |
| amount of erythema and edema | Upto 3 months | patient reported outcome of amount of erythema and edema in number of days postoperatively |
| duration of erythema and edema | Upto 3 months | patient reported outcome of duration of erythema and edema in number of days postoperatively |
Outcome results
None listed