Root Coverage Comparing Suturing Techniques

Sponsor

University of Louisville (Other)

Overall Status

Completed

CT.gov ID

NCT01901822

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Root Coverage	Procedure: Sutured together Procedure: Sutured separately	N/A

Detailed Description

Thirty patients will be selected by meeting the following criteria:

Inclusion Criteria:

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:

Patients with debilitating systemic or diseases that significantly affect the periodontium.
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. 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.
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.
Patients who fail to complete the informed consent form.

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2013

Actual Primary Completion Date :

Jul 1, 2014

Actual Study Completion Date :

Jul 1, 2014

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Percent root coverage [6 months]
The amount of root coverage will be measured and converted to a percent.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Graduate Periodontics Clinic University of Louisville	Louisville	Kentucky	United States	40202

Sponsors and Collaborators

University of Louisville

Investigators

Principal Investigator: Henry Greenwell, DMD, University of Louisville

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Henry Greenwell, Professor, University of Louisville

ClinicalTrials.gov Identifier:

NCT01901822

Other Study ID Numbers:

13.0332

First Posted:

Jul 17, 2013

Last Update Posted:

Dec 8, 2016

Last Verified:

Dec 1, 2016

Keywords provided by Henry Greenwell, Professor, University of Louisville

acellular dermal matrix

Study Results

No Results Posted as of Dec 8, 2016