Root Coverage Comparing Suturing Techniques

Root Coverage Clinical Trial

Official title:

Root Coverage With Acellular Dermal Matrix Using the Coronally Positioned Tunnel Technique Comparing Two Different Suturing Techniques.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01901822
• Other study ID #: 13.0332
• Status: Completed
• Phase: N/A
• First received: July 12, 2013
• Last updated: December 6, 2016
• Start date: September 2013
• Est. completion date: July 2014

Study information

• Verified date: December 2016
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The hypothesis of this study is that coronally positioned tunnel with acellular dermal matrix using a continuous sling suture to secure both the graft and the flap will result in better percent root coverage compared to the continuous sling suturing technique to secure the graft and the flap separately.

Description:

Thirty patients will be selected by meeting the following criteria:

Inclusion Criteria:

A. At least one Miller Class I or II mucogingival defect ≥ 3 mm (Miller 1985). B. The mucogingival defect must be on a non-molar tooth. C. Patients must be between ≥ 18 years of age.

Exclusion Criteria:

A. Patients with debilitating systemic or diseases that significantly affect the periodontium.

B. Patients with a known allergy to any of the materials that will be used in the study, including systemic antibiotics (tetracycline and doxycycline).

C. Patients requiring antibiotic prophylaxis. D. Root surface restorations at the site of recession. E. No detectable cemento-enamel junction. F. Patients who fail to maintain oral hygiene levels of at least 80% plaque free surfaces.

G. Patients who are pregnant or lactating. H. Patients who use tobacco products (smoking or smokeless tobacco). I. Patients with alcohol abuse problems. J. Patients undergoing long-term steroid therapy. K. History of previous root coverage procedures, graft or guided tissue regeneration, on the test teeth.

L. Patients who fail to complete the informed consent form.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least one Miller Class I or II mucogingival defect = 3 mm (Miller 1985).

• The mucogingival defect must be on a non-molar tooth.

• Patients must be between = 18 years of age.

Exclusion Criteria:

• Patients with a known allergy to any of the materials that will be used in the study, including systemic antibiotics (tetracycline and doxycycline).

• Patients requiring antibiotic prophylaxis.

• Root surface restorations at the site of recession.

• No detectable cemento-enamel junction.

• Patients who fail to maintain oral hygiene levels of at least 80% plaque free surfaces.

• Patients who are pregnant or lactating.

• Patients who use tobacco products (smoking or smokeless tobacco).

• Patients with alcohol abuse problems.

• Patients undergoing long-term steroid therapy.

• History of previous root coverage procedures, graft or guided tissue regeneration, on the test teeth.

• Patients who fail to complete the informed consent form.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Root Coverage

Intervention

Procedure:
• Sutured together
The soft tissue and the allograft will be sutured together using a continuous sling suture.
• Sutured separately
The soft tissue and the allograft will be sutured separately using a continuous sling suture.

Locations

Country	Name	City	State
United States	Graduate Periodontics Clinic University of Louisville	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent root coverage	The amount of root coverage will be measured and converted to a percent.	6 months	No