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OpenTrials
Completed

NCT Number: NCT01901822

Root Coverage Comparing 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.

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Key information

Conditions

Root Coverage

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Graduate Periodontics Clinic University of Louisville

Louisville, Kentucky, 40202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sutured together

Procedure

The soft tissue and the allograft will be sutured together using a continuous sling suture.

Sutured separately

Procedure

The soft tissue and the allograft will be sutured separately using a continuous sling suture.

Primary outcomes

  1. Percent root coverage

    Time frame: 6 months

    The amount of root coverage will be measured and converted to a percent.

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 17, 2013
Registry last updated
Dec 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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