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Effect of Connective Tissue Graft Position

Primary Purpose

Gingival Recession

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Coronally advanced flap + connective tissue graft
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring connective tissue graft

Eligibility Criteria

19 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 19 years of age,

    • Periodontally and systemically healthy,
    • FMPS and FMBS <15%,
    • Presence of Miller Class I/II GR defect (≥3 mm in depth) at the buccal aspect of incisors and canines,
    • Presence of identifiable CEJ (step ≤1 mm at CEJ level and/or presence of a root irregularity/abrasion with identifiable CEJ, was accepted),
    • No previous periodontal surgery.

Exclusion Criteria:

  • Smoking,
  • Contraindications for surgery,
  • Presence of recession defects associated with caries, deep abrasion, restoration or pulpal pathology.

Sites / Locations

  • Cukurova University Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

CAF+ CTG positioned apical to the CEJ

CAF+CTG positioned on the CEJ

Arm Description

Connective tissue graft covered by a coronally advanced flap which CTG apical of the CEJ level

Connective tissue graft covered by a coronally advanced flap which CTG on the CEJ level

Outcomes

Primary Outcome Measures

Gingival Recession depth in millimeters
measured from the cemento-enamel junction to the gingival margin
keratinized tissue height in millimeters
measured from the mucogingival junction to the gingival margin
aesthetic evaluation assesed by visual analog scale

Secondary Outcome Measures

Full Information

First Posted
November 13, 2019
Last Updated
November 26, 2019
Sponsor
Cukurova University
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1. Study Identification

Unique Protocol Identification Number
NCT04181892
Brief Title
Effect of Connective Tissue Graft Position
Official Title
The Effects of Connective Tissue Graft Position on Clinical and Aesthetical Outcomes of Gingival Recession Treatment. A Controlled Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Aim: The aim of this study was to compare the root coverage and aesthetic results of CAF+ CTG positioned apical to the CEJ (CAF+CTG-ACEJ) with CAF+CTG positioned on the CEJ (CAF+CTG-CEJ) for treating isolated gingival recession defects. Methods: Thirthy-eight patients with Miller class I and II gingival recessions were enrolled. 19 patients were randomly assigned to the CAF+CTG-ACEJ group or CAF+CTG-CEJ group. Clinical and aesthetical evaluations were made at 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
connective tissue graft

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CAF+ CTG positioned apical to the CEJ
Arm Type
Experimental
Arm Description
Connective tissue graft covered by a coronally advanced flap which CTG apical of the CEJ level
Arm Title
CAF+CTG positioned on the CEJ
Arm Type
Other
Arm Description
Connective tissue graft covered by a coronally advanced flap which CTG on the CEJ level
Intervention Type
Procedure
Intervention Name(s)
Coronally advanced flap + connective tissue graft
Intervention Description
connective tissue graft covered by a coronally advanced flap with connective tissue graft apical of the cementoenamel junction level
Primary Outcome Measure Information:
Title
Gingival Recession depth in millimeters
Description
measured from the cemento-enamel junction to the gingival margin
Time Frame
6 months
Title
keratinized tissue height in millimeters
Description
measured from the mucogingival junction to the gingival margin
Time Frame
6 months
Title
aesthetic evaluation assesed by visual analog scale
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 19 years of age, Periodontally and systemically healthy, FMPS and FMBS <15%, Presence of Miller Class I/II GR defect (≥3 mm in depth) at the buccal aspect of incisors and canines, Presence of identifiable CEJ (step ≤1 mm at CEJ level and/or presence of a root irregularity/abrasion with identifiable CEJ, was accepted), No previous periodontal surgery. Exclusion Criteria: Smoking, Contraindications for surgery, Presence of recession defects associated with caries, deep abrasion, restoration or pulpal pathology.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Onur Ucak Turer, PhD
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cukurova University Faculty of Dentistry
City
Adana
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Connective Tissue Graft Position

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