Amnion Chorion Membrane in Comparison to Subepithelial Connective Tissue Graft in Gingival Recession Coverage

April 21, 2017 updated by: Noha Ayman Ghallab, Cairo University

Clinical Evaluation of Amnion Chorion Membrane in Comparison to Subepithelial Connective Tissue Graft in Gingival Recession Coverage: A Randomized Controlled Clinical Trial.

The present randomized, controlled, parallel-grouped trial included twenty patients (aged 20 to 54 years) suffering from Miller's class I or II gingival recession. Patients were randomly assigned into two equal groups; control group; the coronally advanced flap with the subepithelial connective tissue graft (CAF+SCTG) or the test group; coronally advanced flap with amnion chorion allograft membrane (CAF+AC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The participants were randomly assigned to receive coronally advanced flap (CAF) with amnion chorion membrane or CAF with subepithelial connective tissue graft using a simple randomization procedure with a 1:1 allocation ratio. A computer generated randomization list was drawn up by a faculty member who was not involved in the recruitment. Allocation concealment was achieved by sealed coded opaque envelopes that contained the treatment to be performed to the enrolled subjects based on the randomized numbers. Consequently, patients were allocated to either AC membrane (intervention) or SCTG (control) groups. The sealed envelope containing treatment assignment was opened at time of the surgery and the number was picked by another person other than the operator.

Study Type

Interventional

Enrollment (Actual)

20

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

20 years to 54 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects aged between 18 - 60 years old.
  • Subjects with facial gingival recession defects in anterior and premolar teeth classified as either class I or II defects according to Miller's classification.
  • Subjects able to tolerate surgical periodontal procedures.
  • Accepts the 6 months follow-up period.

Exclusion Criteria:

  • Current and former smokers.
  • Pregnant females.
  • Subjects received any periodontal therapy for a minimum of 6 months prior to the study.
  • Subjects taking drugs known to interfere with wound healing.
  • Subjects with unacceptable oral hygiene with plaque index >2.
  • Teeth with non-carious cervical lesions, cervical caries and malalignment.

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
Experimental: coronally advanced flap with amnion chorion membrane
coronally advanced flap was reflected and amnion chorion allograft membrane was placed under the flap as a guided tissue regeneration barrier.
Biological: amnion chorion allograft membrane
Biologic Amnion chorion allograft membrane derived from placenta of a donor pregnant subject.
Other Names:
  • BioXclude™,Snoasis Medical products, USA.
Active Comparator: subepithelial connective tissue graft
coronally advanced flap was reflected and subepithelial connective tissue graft was harvested from the palate and placed under the flap.
Procedure: coronally advanced flap with the subepithelial connective tissue graft
coronally advanced flap with the placement of subepithelial connective tissue graft harvested from the palate
Other Names:
  • autogenous connective tissue graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recession depth
Time Frame: Change in mm from baseline before surgical procedure to follow up at 6 months.
It is measured as the distance from the cemento-enamel junction to the gingival margin representing the amount of root coverage.
Change in mm from baseline before surgical procedure to follow up at 6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recession Width
Time Frame: Change in mm from baseline before surgical procedure to follow up at 6 months.
It is measured as the distance from mesial and distal papillae along cemento-enamel junction.
Change in mm from baseline before surgical procedure to follow up at 6 months.
Width of keratinized gingiva
Time Frame: Change in mm from baseline before surgical procedure to follow up at 6 months.
It is measured from the mucogingival junction to the free gingival margin.
Change in mm from baseline before surgical procedure to follow up at 6 months.
Probing pocket depth
Time Frame: Change in mm from baseline before surgical procedure to follow up at 6 months.
It is measuring the distance from the base of pocket to the gingival margin.
Change in mm from baseline before surgical procedure to follow up at 6 months.
Clinical attachment level
Time Frame: Change in mm from baseline before surgical procedure to follow up at 6 months.
It is measuring the distance from the apical end of periodontal probe to cemento-enamel junction.
Change in mm from baseline before surgical procedure to follow up at 6 months.
Tissue Biotype
Time Frame: Change in mm from baseline before surgical procedure to follow up at 6 months.
It is measured by penetrating the gingiva with the periodontal probe down to bone after giving local anesthesia to measure the thickness of gingival tissues
Change in mm from baseline before surgical procedure to follow up at 6 months.
root coverage esthetic score
Time Frame: score taken after completion of the study at 6 months
The clinical esthetic evaluation was performed without magnification to evaluate gingival margin, marginal tissue contour, soft tissue texture, mucogingival junction alignment and gingival color
score taken after completion of the study at 6 months
Patient reported outcomes
Time Frame: taken after completion of the study at 6 months
Patients were given certain questions regarding not regretting to perform the surgery, root hypersensitivity and aesthetic satisfaction to be answered at the 6 month follow-up for assessing their satisfaction with the whole procedure.
taken after completion of the study at 6 months

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Chair: Mona Shoeib, MD, Professor of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University.
  • Study Director: Hani El-Nahas, MD, Associate Professor of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University.
  • Principal Investigator: Manar El-Zanaty, Msc., manarzanaty@hotmail.com

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.

General Publications

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

June 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

January 13, 2016

First Submitted That Met QC Criteria

January 13, 2016

First Posted (Estimate)

January 15, 2016

Study Record Updates

Last Update Posted (Actual)

April 24, 2017

Last Update Submitted That Met QC Criteria

April 21, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC_SCTG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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