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

Gingival Recession Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03032094
• Other study ID #: AAAN2667
• Status: Completed
• Phase: N/A
• First received: January 11, 2017
• Last updated: January 24, 2017
• Start date: October 2014
• Est. completion date: May 2016

Study information

• Verified date: January 2017
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Procedure:
• connective tissue graft
palatal connective tissue graft to attain root coverage

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Root coverage	Amount of root coverage attained in millimeters	Upto 3 months
Primary	Root coverage	Amount of root coverage attained in percentage	Upto 3 months
Primary	width of keratinized tissue	Amount of zone of keratinized tissue attained in millimeters	Upto 3 months
Primary	width of keratinized tissue	Amount of zone of keratinized tissue attained in percentage	Upto 3 months
Secondary	thickness of keratinized tissue		Upto 3 months
Secondary	amount of erythema and edema	patient reported outcome of amount of erythema and edema in number of days postoperatively	Upto 3 months
Secondary	duration of erythema and edema	patient reported outcome of duration of erythema and edema in number of days postoperatively	Upto 3 months