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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AC_SCTG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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