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

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ClinicalTrials.gov Identifier: NCT02656732
Recruitment Status : Completed
First Posted : January 15, 2016
Last Update Posted : April 24, 2017
Sponsor:
Information provided by (Responsible Party):
Noha Ayman Ghallab, Cairo University

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Gingival Recession Biological: amnion chorion allograft membrane Procedure: coronally advanced flap with the subepithelial connective tissue graft Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Amnion Chorion Membrane in Comparison to Subepithelial Connective Tissue Graft in Gingival Recession Coverage: A Randomized Controlled Clinical Trial.
Study Start Date : June 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : October 2015

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 Name: 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 Name: autogenous connective tissue graft




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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

  7. 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.



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Ages Eligible for Study:   20 Years to 54 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656732


Sponsors and Collaborators
Cairo University
Investigators
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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 of Results:

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Responsible Party: Noha Ayman Ghallab, Associate Professor of Oral Medicine and Periodontology, Cairo University
ClinicalTrials.gov Identifier: NCT02656732     History of Changes
Other Study ID Numbers: AC_SCTG
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: April 24, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Gingival Recession
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy