Root Coverage Comparing Suturing Techniques

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

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.

Study Overview

• Status: Completed
• Conditions: Root Coverage
• Intervention / Treatment: Procedure: Sutured separately; Procedure: Sutured together

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Graduate Periodontics Clinic University of Louisville

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:

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent root coverage	The amount of root coverage will be measured and converted to a percent.	6 months

Collaborators and Investigators

• Sponsor: University of Louisville

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: July 12, 2013
• First Submitted That Met QC Criteria: July 16, 2013
• First Posted (Estimate): July 17, 2013

Study Record Updates

• Last Update Posted (Estimate): December 8, 2016
• Last Update Submitted That Met QC Criteria: December 6, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: acellular dermal matrix
• Other Study ID Numbers: 13.0332