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Completed

NCT Number: NCT04637451

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

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.

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Key information

Conditions

Gingival Recession Gingival Diseases Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sibel Kayaaltı Yüksek

Istanbul, Tuzla, 34852, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Root coverage treatment

Procedure

Gingival unit graft Connective tissue graft

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. Change from Baseline Root Hypersensitivity at 6 month

    Time frame: Baseline 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)

  2. Change from Baseline Patient Satisfaction at 6 month

    Time frame: Baseline 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)

  3. Change from Baseline Pain at 1 week

    Time frame: Baseline 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)

  4. Change from Baseline Pain at 2 week

    Time frame: Baseline 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)

Sponsors and collaborators

Lead sponsor

Okan University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 19, 2020
Registry last updated
Nov 19, 2020

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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