NCT03053921

Brief Summary

Aim of the study was to evaluate the clinical efficacy of placental membrane with coronally advanced flap in covering single and multiple Miller's class I and II gingival recession defects.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

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

August 19, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 15, 2017

Completed
Last Updated

February 15, 2017

Status Verified

January 1, 2017

Enrollment Period

7 months

First QC Date

February 6, 2017

Last Update Submit

February 12, 2017

Conditions

Gingival Recession

Keywords

gingival recessionZuchellis technique,placental membrane

Outcome Measures

Primary Outcomes (1)

  • Height of Gingival recession

    The height of gingival recession was measured from the cemento-enamel junction to the gingival margin using Williams periodontal probe

    6 months

Secondary Outcomes (2)

  • Clinical attachment level

    Baseline and 6 months

  • Width of Keratinized Gingiva

    Baseline and 6 months

Study Arms (2)

recession coverage

PLACEBO COMPARATOR

30 recession defects treated with Zucchelli's technique.

Procedure: recession coverage

recession coverage and membrane

ACTIVE COMPARATOR

30 recession defects treated with Zucchelli's technique along with placental membrane.

Procedure: recession coverage and membrane

Interventions

recession coveragePROCEDURE

recession coverage done using Zuchellis technique

Also known as: root coverage technique
recession coverage
recession coverage and membranePROCEDURE

recession coverage done using Zuchellis technique with placental membrane

Also known as: root coverage technique with membrane
recession coverage and membrane

Eligibility Criteria

Age23 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients within the age group 23 to 55 years
  • Bilateral, upper or lower, Miller's class I and Class II gingival recession defects confined to the anterior and premolar region.
  • Presence of identifiable cemento-enamel junction
  • Presence of keratinized tissue apical to the exposed root

You may not qualify if:

  • Systemic complications
  • Occlusal interferences
  • Any contraindication for periodontal surgery and taking medication which are known to interfere with periodontal tissue health or healing
  • Previous periodontal surgery on the involved site
  • Smokers
  • Pregnant and lactating mothers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Zucchelli G, Mele M, Mazzotti C, Marzadori M, Montebugnoli L, De Sanctis M. Coronally advanced flap with and without vertical releasing incisions for the treatment of multiple gingival recessions: a comparative controlled randomized clinical trial. J Periodontol. 2009 Jul;80(7):1083-94. doi: 10.1902/jop.2009.090041.

    PMID: 19563288BACKGROUND

  • 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: 26501023BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Sarah George, BDS

    Meenakshi Ammal Dental College and Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 6, 2017

First Posted

February 15, 2017

Study Start

August 19, 2015

Primary Completion

March 23, 2016

Study Completion

June 15, 2016

Last Updated

February 15, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share