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

Gingival Recession Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02656732
• Other study ID #: AC_SCTG
• Status: Completed
• Phase: N/A
• First received: January 13, 2016
• Last updated: April 21, 2017
• Start date: June 2014
• Est. completion date: October 2015

Study information

• Verified date: April 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 54 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Biological:
• amnion chorion allograft membrane
Biologic Amnion chorion allograft membrane derived from placenta of a donor pregnant subject.

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (6)

Cairo F, Cortellini P, Tonetti M, Nieri M, Mervelt J, Cincinelli S, Pini-Prato G. Coronally advanced flap with and without connective tissue graft for the treatment of single maxillary gingival recession with loss of inter-dental attachment. A randomized — View Citation

Cairo F, Nieri M, Pagliaro U. Efficacy of periodontal plastic surgery procedures in the treatment of localized facial gingival recessions. A systematic review. J Clin Periodontol. 2014 Apr;41 Suppl 15:S44-62. doi: 10.1111/jcpe.12182. Review. — View Citation

Chakraborthy S, Sambashivaiah S, Kulal R, Bilchodmath S. Amnion and Chorion Allografts in Combination with Coronally Advanced Flap in the Treatment of Gingival Recession: A Clinical Study. J Clin Diagn Res. 2015 Sep;9(9):ZC98-ZC101. doi: 10.7860/JCDR/2015 — View Citation

Chambrone L, Tatakis DN. Periodontal soft tissue root coverage procedures: a systematic review from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S8-51. doi: 10.1902/jop.2015.130674. Review. — View Citation

de Sanctis M, Zucchelli G. Coronally advanced flap: a modified surgical approach for isolated recession-type defects: three-year results. J Clin Periodontol. 2007 Mar;34(3):262-8. — View Citation

Ghahroudi AA, Khorsand A, Rokn AR, Sabounchi SS, Shayesteh YS, Soolari A. Comparison of amnion allograft with connective tissue graft for root coverage procedures: a double-blind, randomized, controlled clinical trial. J Int Acad Periodontol. 2013 Oct;15( — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recession depth	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	Recession Width	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.
Secondary	Width of keratinized gingiva	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.
Secondary	Probing pocket depth	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.
Secondary	Clinical attachment level	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.
Secondary	Tissue Biotype	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.
Secondary	root coverage esthetic score	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
Secondary	Patient reported outcomes	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