Clinical Trial: Efficacy of Methods to Treat Multiple Gingival Recession Defects

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: An Open Prospective Randomized Controlled Clinical Trial to Examine the Efficacy of Methods to Treat Multiple Gingival Recession Defects

Brief Summary:

Rationale: Treatment of gingival recession defects requires coronal advancement of the gingival margin due to patient esthetic demand, tooth sensitivity and improvement of tooth prognosis, which can be accomplished either through a flap procedure or through a tunnel. It will be desirable to determine the efficacy of Vestibular Incision Subperiosteal Tunnel Access (VISTA) to Coronally Advanced Flap (CAF) procedure and intrasulcular tunneling.

Another aspect of the study is to determine whether autologous concentrate of platelets and leukocytes (leukocyte-platelet-rich fibrin; L-PRF) has equivalent efficacy to connective tissue autologous graft harvested from the palate.

The overall objective of this study is to evaluate the effectiveness of therapeutic modalities for the treatment of multiple gingival recession defects.

The study is designed as a prospective, randomized controlled clinical trial. Four groups will be compared:

Group 1: Coronally Advanced Flap (CAF) Group 2: VISTA Group 3: Intrasulcular tunneling (IST) Group 4: VISTA + L-PRF

Each of the groups will be treated without any graft material in order to examine the efficacy of coronal advancement and periodontal root coverage without the confounding variable of graft material. These techniques don't require any additional graft if there is adequate amount of keratinized gingiva

The study population will be patients who present to Advanced Graduate Program in Periodontology at the University of Southern California, USA, and are deemed to require treatment of multiple gingival recession defects. A total sample of 100 participants (23 participants per group) will provide

Detailed Summary:
Sponsor: University of Southern California

Current Primary Outcome: Complete root coverage [ Time Frame: 12 months ]

Complete coverage of the recession defect following surgery. It will be a binary outcome (Yes or No)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Clinical Attachment Level gain [ Time Frame: 12 months ]
    Gain of clinical attachment defined by the distance between the cement-enamel junction to the depth of the periodontal pocket around the teeth measured in mm by a periodontal probe
  • % root coverage [ Time Frame: 12 months ]
    Percentage of the denuded root surface which is covered following the procedure
  • Gingival Thickness Gain [ Time Frame: 12 months ]
    Thickness of the gingival following the procedure
  • Gingival Volume Gain [ Time Frame: 12 months ]
    The gingival volume gain following the procedure


Original Secondary Outcome: Same as current

Information By: University of Southern California

Dates:
Date Received: April 18, 2017
Date Started: May 1, 2017
Date Completion: June 1, 2020
Last Updated: May 9, 2017
Last Verified: May 2017