Connective Tissue Grafting for Single Tooth Recession & the Impact of the Thickness of the Palatal Harvest Tissue

N/ACompletedNCT03032094

Columbia University42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Gingival Recession

Interventions

connective tissue graftPROCEDURE

palatal connective tissue graft to attain root coverage

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 -

Outcomes

Primary Outcomes

Root coverage

Amount of root coverage attained in millimeters

Time frame: Upto 3 months

Root coverage

Amount of root coverage attained in percentage

Time frame: Upto 3 months

width of keratinized tissue

Amount of zone of keratinized tissue attained in millimeters

Time frame: Upto 3 months

width of keratinized tissue

Amount of zone of keratinized tissue attained in percentage

Time frame: Upto 3 months

Secondary Outcomes

thickness of keratinized tissue

Time frame: Upto 3 months

amount of erythema and edema

patient reported outcome of amount of erythema and edema in number of days postoperatively

Time frame: Upto 3 months

duration of erythema and edema

patient reported outcome of duration of erythema and edema in number of days postoperatively

Time frame: Upto 3 months

Data from ClinicalTrials.gov

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