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

Connective Tissue Grafting for Single Tooth Recession Defects & the Impact of the Thickness of the Palatal Harvest Tissue: A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Gingival Recession
• Intervention / Treatment: Procedure: connective tissue graft

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1mm thick graft; connective tissue graft of 1mm thickness	Procedure: connective tissue graft; palatal connective tissue graft to attain root coverage
Active Comparator: 2mm thick graft; connective tissue graft of 2mm thickness	Procedure: connective tissue graft; palatal connective tissue graft to attain root coverage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
duration of erythema and edema	patient reported outcome of duration of erythema and edema in number of days postoperatively	Upto 3 months

Collaborators and Investigators

• Sponsor: Columbia University
• Investigators: Principal Investigator: Evanthia Lalla, DDS, Columbia University

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: January 11, 2017
• First Submitted That Met QC Criteria: January 24, 2017
• First Posted (Estimate): January 26, 2017

Study Record Updates

• Last Update Posted (Estimate): January 26, 2017
• Last Update Submitted That Met QC Criteria: January 24, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Gingival Recession
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: AAAN2667

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No