NCT02656732

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2016

Completed
Last Updated

April 24, 2017

Status Verified

April 1, 2017

Enrollment Period

10 months

First QC Date

January 13, 2016

Last Update Submit

April 21, 2017

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Recession Width

    Change in mm from baseline before surgical procedure to follow up at 6 months.

  • Width of keratinized gingiva

    Change in mm from baseline before surgical procedure to follow up at 6 months.

  • Probing pocket depth

    Change in mm from baseline before surgical procedure to follow up at 6 months.

  • Clinical attachment level

    Change in mm from baseline before surgical procedure to follow up at 6 months.

  • Tissue Biotype

    Change in mm from baseline before surgical procedure to follow up at 6 months.

  • +2 more secondary outcomes

Study Arms (2)

coronally advanced flap with amnion chorion membrane

EXPERIMENTAL

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

subepithelial connective tissue graft

ACTIVE COMPARATOR

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

Interventions

amnion chorion allograft membraneBIOLOGICAL

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

Also known as: BioXcludeâ„¢,Snoasis Medical products, USA.
coronally advanced flap with amnion chorion membrane
coronally advanced flap with the subepithelial connective tissue graftPROCEDURE

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

Also known as: autogenous connective tissue graft
subepithelial connective tissue graft

Eligibility Criteria

Age20 Years - 54 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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 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.

    PMID: 22639845RESULT

  • 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.

    PMID: 24641000RESULT

  • 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.

    PMID: 25644302RESULT

  • 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.

    PMID: 26501023RESULT

  • 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.

    PMID: 17309597RESULT

  • 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.

    PMID: 24364174RESULT

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Mona Shoeib, MD

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

    STUDY CHAIR

  • Hani El-Nahas, MD

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

    STUDY DIRECTOR

  • Manar El-Zanaty, Msc.

    manarzanaty@hotmail.com

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Oral Medicine and Periodontology

Study Record Dates

First Submitted

January 13, 2016

First Posted

January 15, 2016

Study Start

June 1, 2014

Primary Completion

April 1, 2015

Study Completion

October 1, 2015

Last Updated

April 24, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share