Comparison of Two Techniques in Gingival Recession Treatment. One-year Clinical Follow-up Study

September 27, 2019 updated by: H. Gencay Keceli, Kırıkkale University
42 patients were treated either with E-CTG (N=20) or SCAF (N=22). The recordings included clinician-based (recession depth, recession width, probing depth, clinical attachment level, keratinized tissue width, tissue thickness, clinical attachment gain (CAG), root coverage (RC), keratinized tissue change (KTC)) and patient-based (wound healing index (WHI), dentine hypersensitivity (DH), tissue appearance, patient expectations and aesthetics) parameters that were taken at baseline, T1 (sixth week), T2 (sixth month) and T3 (first year).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • single Miller I GR defects ≤3mm at upper anterior or premolar teeth
  • systemically healthy
  • identifiable cemento-enamel junction (CEJ)
  • PD ≤3 mm

Exclusion Criteria:

  • periodontal surgery experience in the past two years
  • excessive contacts
  • mobility
  • caries
  • loss of vitality
  • smoking
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: E-CTG
Envelope connective tissue graft
Envelope connective tissue graft
Active Comparator: SCAF
Semilunar connective tissue graft
Envelope connective tissue graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recession depth
Time Frame: baseline
Distance between CEJ and GM
baseline
recession depth
Time Frame: 6 weeks
Distance between CEJ and GM
6 weeks
recession depth
Time Frame: 6 months
Distance between CEJ and GM
6 months
recession depth
Time Frame: 12 months
Distance between CEJ and GM
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recession width
Time Frame: baseline
horizontal distance between two borders of recession at CEJ level
baseline
recession width
Time Frame: 6 weeks
horizontal distance between two borders of recession at CEJ level
6 weeks
recession width
Time Frame: 6 months
horizontal distance between two borders of recession at CEJ level
6 months
recession width
Time Frame: 12 months
horizontal distance between two borders of recession at CEJ level
12 months
probing depth
Time Frame: baseline
distance between GM and base of gingival sulcus
baseline
probing depth
Time Frame: 6 weeks
distance between GM and base of gingival sulcus
6 weeks
probing depth
Time Frame: 6 months
distance between GM and base of gingival sulcus
6 months
probing depth
Time Frame: 12 months
distance between GM and base of gingival sulcus
12 months
clinical attachment level
Time Frame: baseline
distance between CEJ and base of gingival sulcus
baseline
clinical attachment level
Time Frame: 6 weeks
distance between CEJ and base of gingival sulcus
6 weeks
clinical attachment level
Time Frame: 6 months
distance between CEJ and base of gingival sulcus
6 months
clinical attachment level
Time Frame: 12 months
distance between CEJ and base of gingival sulcus
12 months
keratinized tissue width
Time Frame: baseline
distance between GM and MGJ
baseline
keratinized tissue width
Time Frame: 6 weeks
distance between GM and MGJ
6 weeks
keratinized tissue width
Time Frame: 6 months
distance between GM and MGJ
6 months
keratinized tissue width
Time Frame: 12 months
distance between GM and MGJ
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

September 26, 2019

First Submitted That Met QC Criteria

September 27, 2019

First Posted (Actual)

September 30, 2019

Study Record Updates

Last Update Posted (Actual)

September 30, 2019

Last Update Submitted That Met QC Criteria

September 27, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • SerdarEvginer

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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