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Clinical Trials/NCT04637451
NCT04637451
Completed
Not Applicable

The Comparison of the Efficacy of Gingival Unit Graft With Connective Tissue Graft in Root Coverage: A Randomized Split-Mouth Clinical Trial

Okan University1 site in 1 country16 target enrollmentJuly 1, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gingival Recession
Sponsor
Okan University
Enrollment
16
Locations
1
Primary Endpoint
Change from Baseline Keratinized Gingiva Height at 6 month
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The purpose of the study is to compare the clinical effectiveness of gingival unit graft (GUG) and connective tissues graft (CTG) in Miller's class I and II gingival recession.

Detailed Description

Patients who accept the study have provided information about the study and required a written informed consent form. The clinical effectiveness of two different periodontal surgical techniques (gingival unit graft and connective tissue graft) in gingival recessions will be evaluated. Periodontal measurements (gingival recession, keratinized gingiva height) and patient-reported outcomes (intra and post-operative pain, patient satisfaction and hypersensitivity) are defined.

Registry
clinicaltrials.gov
Start Date
July 1, 2015
End Date
July 30, 2016
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Okan University
Responsible Party
Principal Investigator
Principal Investigator

Sibel Kayaalti-Yuksek

Assistant Professor

Okan University

Eligibility Criteria

Inclusion Criteria

  • Systemic healthy individuals
  • Presence Miller's class I and II gingival recession in the anterior and premolar teeth

Exclusion Criteria

  • Age \<18 years
  • Pregnancy
  • Lactation
  • Any cardiovascular, renal or hepatic conditions
  • History of periodontal surgery
  • Tooth mobility
  • Presence of probing depth \>3 mm and caries or restorations in the teeth undergoing treatment

Outcomes

Primary Outcomes

Change from Baseline Keratinized Gingiva Height at 6 month

Time Frame: Baseline and month 6.

Keratinized gingiva height, measured as the distance from the gingival margin to the mucogingival line. The measurement is recorded in millimeters. Change= (6 month score-baseline score)

Change from Baseline Gingival Recession Depth at 6 month

Time Frame: Baseline and month 6.

The gingival recession depth consists of the distance from the cement-enamel junction to the most apical extension of the gingival margin. The measurement is recorded in millimeters. Change= (6 month score-baseline score)

Secondary Outcomes

  • Change from Baseline Pain at 2 week(Baseline and week 2.)
  • Change from Baseline Patient Satisfaction at 6 month(Baseline and month 6.)
  • Change from Baseline Root Hypersensitivity at 6 month(Baseline and month 6.)
  • Change from Baseline Pain at 1 week(Baseline and week 1.)

Study Sites (1)

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