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The Comparison of the Efficacy of Gingival Unit Graft With Connective Tissue Graft in Root Coverage

Not Applicable
Completed
Conditions
Gingival Recession
Periodontal Diseases
Interventions
Procedure: Root coverage treatment
Registration Number
NCT04637451
Lead Sponsor
Okan University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
16
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Connective Tissue GraftRoot coverage treatmentFor Control group, gingival recessions were treated with connective tissue graft.
Gingival Unit GraftRoot coverage treatmentFor test group, gingival recessions were treated with gingival unit graft.
Primary Outcome Measures
NameTimeMethod
Change from Baseline Keratinized Gingiva Height at 6 monthBaseline 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 monthBaseline 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 Outcome Measures
NameTimeMethod
Change from Baseline Pain at 2 weekBaseline and week 2.

Pain perception of the surgery at intra and post-operative period (week 2) utilizing a VNS test are defined. Possible scores range from 0 (no pain) to 10 (worst possible pain). Change= (2 week score-baseline score)

Change from Baseline Patient Satisfaction at 6 monthBaseline and month 6.

The patient satisfaction with the gingiva position, structure and color of the gingival recessions sites utilizing a VNS test (0=not satisfied and 10=very satisfied) are defined. Possible scores range from 0 (not satisfied) to 10 (very satisfied). Change= (6 month score-baseline score)

Change from Baseline Root Hypersensitivity at 6 monthBaseline and month 6.

Root hypersensitivity at baseline and post-operative 6 month utilizing a visual numerical scale (VNS) test are defined. Possible scores range from (0=no sensitive and 10= worst possible sensitive). Change= (6 month score-baseline score)

Change from Baseline Pain at 1 weekBaseline and week 1.

Pain perception of the surgery at intra and post-operative period (week 1) utilizing a VNS test are defined. Possible scores range from 0 (no pain) to 10 (worst possible pain). Change= (1 week score-baseline score)

Trial Locations

Locations (1)

Sibel Kayaaltı Yüksek

🇹🇷

Istanbul, Tuzla, Turkey

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