NCT04181892

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2019

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 2, 2019

Completed
Last Updated

December 2, 2019

Status Verified

November 1, 2019

Enrollment Period

11 months

First QC Date

November 13, 2019

Last Update Submit

November 26, 2019

Conditions

Keywords

connective tissue graft

Outcome Measures

Primary Outcomes (3)

  • Gingival Recession depth in millimeters

    measured from the cemento-enamel junction to the gingival margin

    6 months

  • keratinized tissue height in millimeters

    measured from the mucogingival junction to the gingival margin

    6 months

  • aesthetic evaluation assesed by visual analog scale

    6 months

Study Arms (2)

CAF+ CTG positioned apical to the CEJ

EXPERIMENTAL

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

Procedure: Coronally advanced flap + connective tissue graft

CAF+CTG positioned on the CEJ

OTHER

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

Procedure: Coronally advanced flap + connective tissue graft

Interventions

connective tissue graft covered by a coronally advanced flap with connective tissue graft apical of the cementoenamel junction level

CAF+ CTG positioned apical to the CEJCAF+CTG positioned on the CEJ

Eligibility Criteria

Age19 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University Faculty of Dentistry

Adana, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Onur Ucak Turer, PhD

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 13, 2019

First Posted

December 2, 2019

Study Start

March 1, 2018

Primary Completion

February 1, 2019

Study Completion

September 1, 2019

Last Updated

December 2, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations