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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1mm thick graft | Active Comparator | connective tissue graft of 1mm thickness |
|
| 2mm thick graft | Active Comparator | connective tissue graft of 2mm thickness |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| connective tissue graft | Procedure | palatal connective tissue graft to attain root coverage |
|
| Measure | Description | Time Frame |
|---|---|---|
| Root coverage | Amount of root coverage attained in millimeters | Upto 3 months |
| Root coverage | Amount of root coverage attained in percentage | Upto 3 months |
| width of keratinized tissue | Amount of zone of keratinized tissue attained in millimeters | Upto 3 months |
| width of keratinized tissue | Amount of zone of keratinized tissue attained in percentage | Upto 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| thickness of keratinized tissue | Upto 3 months | |
| amount of erythema and edema | patient reported outcome of amount of erythema and edema in number of days postoperatively | Upto 3 months |
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Inclusion Criteria:
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 -
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| Name | Affiliation | Role |
|---|---|---|
| Evanthia Lalla, DDS | Columbia University | Principal Investigator |
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| ID | Term |
|---|---|
| D005889 | Gingival Recession |
| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| duration of erythema and edema | patient reported outcome of duration of erythema and edema in number of days postoperatively | Upto 3 months |
| D055093 |
| Periodontal Atrophy |