Clinical trial NCT03032094: Connective Tissue Grafting for Single Tooth Recession & the Impact of the Thickness of the Palatal Harvest Tissue
Official title: Connective Tissue Grafting for Single Tooth Recession Defects & the Impact of the Thickness of the Palatal Harvest Tissue: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Keywords: Gingival Recession
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2017-01-26
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 -

Primary outcomes:
measure: Root coverage
timeFrame: Upto 3 months
measure: Root coverage
timeFrame: Upto 3 months
measure: width of keratinized tissue
timeFrame: Upto 3 months
measure: width of keratinized tissue
timeFrame: Upto 3 months
Secondary outcomes:
measure: thickness of keratinized tissue
timeFrame: Upto 3 months
measure: amount of erythema and edema
timeFrame: Upto 3 months
measure: duration of erythema and edema
timeFrame: Upto 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Columbia University
name: Evanthia Lalla, DDS
role: PRINCIPAL_INVESTIGATOR
References: