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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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).

Detailed Summary: 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.
Sponsor: Cairo University

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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
  • 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.


Original Secondary Outcome: Same as current

Information By: Cairo University

Dates:
Date Received: January 13, 2016
Date Started: June 2014
Date Completion:
Last Updated: April 21, 2017
Last Verified: April 2017