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

Not Applicable

Completed

• Conditions: Gingival Recession
• Interventions: Procedure: connective tissue graft

• Registration Number: NCT03032094
• Lead Sponsor: Columbia University

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 Timeline

• Study Start: 2014-10
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2017-01
• Study First Submitted: 2017-01-11
• Study First Submitted QC: 2017-01-24
• Last Update Submitted: 2017-01-24
• Study First Posted: 2017-01-26
• Last Update Posted: 2017-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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) -

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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 -

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1mm thick graft	connective tissue graft	connective tissue graft of 1mm thickness
2mm thick graft	connective tissue graft	connective tissue graft of 2mm thickness

Primary Outcome Measures

Name	Time	Method
width of keratinized tissue	Upto 3 months	Amount of zone of keratinized tissue attained in percentage
Root coverage	Upto 3 months	Amount of root coverage attained in percentage

Secondary Outcome Measures

Name	Time	Method
duration of erythema and edema	Upto 3 months	patient reported outcome of duration of erythema and edema in number of days postoperatively
amount of erythema and edema	Upto 3 months	patient reported outcome of amount of erythema and edema in number of days postoperatively
thickness of keratinized tissue	Upto 3 months