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Root Coverage Comparing Suturing Techniques

University of Louisville (UOFL) logo

University of Louisville (UOFL)

Status

Completed

Conditions

Root Coverage

Treatments

Procedure: Sutured separately
Procedure: Sutured together

Study type

Interventional

Funder types

Other

Identifiers

NCT01901822
13.0332

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

16 participants in 2 patient groups

Sutured separately
Active Comparator group
Description:
The soft tissue and the allograft will each be sutured separately using a continuous sling suture.
Treatment:
Procedure: Sutured separately
Sutured together
Experimental group
Description:
The soft tissue and the allograft will be sutured together using a continuous sling suture.
Treatment:
Procedure: Sutured together

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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