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Trial record 35 of 3261 for:    Louisville

Root Coverage Comparing Suturing Techniques

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01901822
Recruitment Status : Completed
First Posted : July 17, 2013
Last Update Posted : December 8, 2016
Sponsor:
Information provided by (Responsible Party):

July 12, 2013
July 17, 2013
December 8, 2016
September 2013
July 2014   (Final data collection date for primary outcome measure)
Percent root coverage [ Time Frame: 6 months ]
The amount of root coverage will be measured and converted to a percent.
Same as current
Complete list of historical versions of study NCT01901822 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Root Coverage
  • Procedure: Sutured together
    The soft tissue and the allograft will be sutured together using a continuous sling suture.
  • Procedure: Sutured separately
    The soft tissue and the allograft will be sutured separately using a continuous sling suture.
  • Active Comparator: Sutured separately
    The soft tissue and the allograft will each be sutured separately using a continuous sling suture.
    Intervention: Procedure: Sutured separately
  • Experimental: Sutured together
    The soft tissue and the allograft will be sutured together using a continuous sling suture.
    Intervention: Procedure: Sutured together
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
July 2014
July 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01901822
13.0332
No
Not Provided
Not Provided
Henry Greenwell, University of Louisville
University of Louisville
Not Provided
Principal Investigator: Henry Greenwell, DMD University of Louisville
University of Louisville
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP