Placental Membrane for Root Coverage

NCT ID: NCT03053921

Last Updated: 2017-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-19

Study Completion Date

2016-06-15

Brief Summary

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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.

Detailed Description

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STUDY DESIGN A total number of 60 teeth in 15 subjects were selected. Patients with bilateral Miller's class I and II gingival recession defects in the maxillary or mandibular anterior and premolar region were selected and divided into two groups using a split mouth design.

GroupI (Control) -30 recession defects treated with coronally advanced flap alone, using Zucchelli's technique.

Group II (Test) - 30 recession defects treated with coronally advanced flap, using Zucchelli's technique along with placental membrane.

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CLINICAL PARAMETERS:

1. Probing Pocket Depth(PPD)
2. Clinical Attachment Level(CAL)
3. Height of Gingival Recession(HGR)
4. Width of Gingival Recession(WGR)
5. Width of Keratinized Gingiva(WKG) The clinical parameters were assessed \& recorded on 0 day, 90th day and 180th day

Conditions

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Gingival Recession

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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recession coverage

30 recession defects treated with Zucchelli's technique.

Group Type PLACEBO_COMPARATOR

recession coverage

Intervention Type PROCEDURE

recession coverage done using Zuchellis technique

recession coverage and membrane

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

Group Type ACTIVE_COMPARATOR

recession coverage and membrane

Intervention Type PROCEDURE

recession coverage done using Zuchellis technique with placental membrane

Interventions

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recession coverage

recession coverage done using Zuchellis technique

Intervention Type PROCEDURE

recession coverage and membrane

recession coverage done using Zuchellis technique with placental membrane

Intervention Type PROCEDURE

Other Intervention Names

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root coverage technique root coverage technique with membrane

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Systemic complications
2. Occlusal interferences
3. Any contraindication for periodontal surgery and taking medication which are known to interfere with periodontal tissue health or healing
4. Previous periodontal surgery on the involved site
5. Smokers
6. Pregnant and lactating mothers
Minimum Eligible Age

23 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Meenakshi Ammal Dental College and Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr.Jaideep Mahendra

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sarah George, BDS

Role: PRINCIPAL_INVESTIGATOR

Meenakshi Ammal Dental College and Hospitals

References

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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.

Reference Type BACKGROUND
PMID: 19563288 (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 BACKGROUND
PMID: 26501023 (View on PubMed)

Other Identifiers

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MADC/IRB/2015/94

Identifier Type: -

Identifier Source: org_study_id

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