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Completed

NCT Number: NCT02656732

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

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).

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Key information

Conditions

Gingival Recession Gingival Diseases Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

20 year–54 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

amnion chorion allograft membrane

Biological

Biologic Amnion chorion allograft membrane derived from placenta of a donor pregnant subject.

Other names: BioXclude™,Snoasis Medical products, USA.

coronally advanced flap with the subepithelial connective tissue graft

Procedure

coronally advanced flap with the placement of subepithelial connective tissue graft harvested from the palate

Other names: autogenous connective tissue graft

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 15, 2016
Registry last updated
Apr 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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