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Trial record 38 of 3323 for:    Louisville

Root Coverage Comparing Suturing Techniques

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ClinicalTrials.gov Identifier: NCT01901822
Recruitment Status : Completed
First Posted : July 17, 2013
Last Update Posted : December 8, 2016
Sponsor:
Information provided by (Responsible Party):
Henry Greenwell, 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.

Condition or disease Intervention/treatment Phase
Root Coverage Procedure: Sutured together Procedure: Sutured separately Not Applicable

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  (Clinical Trial)
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 : September 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

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.



Primary Outcome Measures :
  1. Percent root coverage [ Time Frame: 6 months ]
    The amount of root coverage will be measured and converted to a percent.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01901822


Locations
United States, Kentucky
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

Responsible Party: Henry Greenwell, Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT01901822     History of Changes
Other Study ID Numbers: 13.0332
First Posted: July 17, 2013    Key Record Dates
Last Update Posted: December 8, 2016
Last Verified: December 2016

Keywords provided by Henry Greenwell, University of Louisville:
acellular dermal matrix