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

NCT ID: NCT02656732

Last Updated: 2017-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-10-31

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 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.

Conditions

Gingival Recession

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

amnion chorion allograft membrane

Intervention Type: BIOLOGICAL

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

subepithelial connective tissue graft

coronally advanced flap was reflected and subepithelial connective tissue graft was harvested from the palate and placed under the flap.

Group Type: ACTIVE_COMPARATOR

coronally advanced flap with the subepithelial connective tissue graft

Intervention Type: PROCEDURE

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

Interventions

amnion chorion allograft membrane

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

Intervention Type: BIOLOGICAL

coronally advanced flap with the subepithelial connective tissue graft

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

Intervention Type: PROCEDURE

Other Intervention Names

BioXclude™,Snoasis Medical products, USA.; autogenous connective tissue graft

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 54 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Noha Ayman Ghallab

Associate Professor of Oral Medicine and Periodontology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mona Shoeib, MD

Role: STUDY_CHAIR

Professor of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University.

Hani El-Nahas, MD

Role: STUDY_DIRECTOR

Associate Professor of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University.

Manar El-Zanaty, Msc.

Role: PRINCIPAL_INVESTIGATOR

manarzanaty@hotmail.com

References

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 controlled clinical trial. J Clin Periodontol. 2012 Aug;39(8):760-8. doi: 10.1111/j.1600-051X.2012.01903.x. Epub 2012 May 28.

Reference Type: RESULT

PMID: 22639845 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24641000 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25644302 (View on PubMed)

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/2015/12971.6572. Epub 2015 Sep 1.

Reference Type: RESULT

PMID: 26501023 (View on PubMed)

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. doi: 10.1111/j.1600-051X.2006.01039.x.

Reference Type: RESULT

PMID: 17309597 (View on PubMed)

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(4):101-12.

Reference Type: RESULT

PMID: 24364174 (View on PubMed)

Other Identifiers

AC_SCTG

Identifier Type: -

Identifier Source: org_study_id