Root Coverage Comparing Suturing Techniques

Not Applicable

Completed

• Conditions: Root Coverage
• Interventions: Procedure: Sutured together; Procedure: Sutured separately

• Registration Number: NCT01901822
• Lead Sponsor: University of Louisville

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2013-07-12
• Study First Submitted QC: 2013-07-16
• Study First Posted: 2013-07-17
• Study Start: 2013-09
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-06
• Last Update Posted: 2016-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sutured together	Sutured together	The soft tissue and the allograft will be sutured together using a continuous sling suture.
Sutured separately	Sutured separately	The soft tissue and the allograft will each be sutured separately using a continuous sling suture.

Primary Outcome Measures

Name	Time	Method
Percent root coverage	6 months	The amount of root coverage will be measured and converted to a percent.

Trial Locations

Locations (1)

Graduate Periodontics Clinic University of Louisville; 🇺🇸 Louisville, Kentucky, United States