Placental Membrane for Root Coverage

Not Applicable

Completed

• Conditions: Gingival Recession
• Interventions: Procedure: recession coverage and membrane; Procedure: recession coverage

• Registration Number: NCT03053921
• Lead Sponsor: Meenakshi Ammal Dental College and Hospital

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.

Detailed Description

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

Study Timeline

• Study Start: 2015-08-19
• Primary Completion: 2016-03-23
• Study Completion: 2016-06-15
• Status Verified: 2017-01
• Study First Submitted: 2017-02-06
• Study First Submitted QC: 2017-02-12
• Last Update Submitted: 2017-02-12
• Study First Posted: 2017-02-15
• Last Update Posted: 2017-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
recession coverage and membrane	recession coverage and membrane	30 recession defects treated with Zucchelli's technique along with placental membrane.
recession coverage	recession coverage	30 recession defects treated with Zucchelli's technique.

Primary Outcome Measures

Name	Time	Method
Height of Gingival recession	6 months	The height of gingival recession was measured from the cemento-enamel junction to the gingival margin using Williams periodontal probe

Secondary Outcome Measures

Name	Time	Method
Width of Keratinized Gingiva	Baseline and 6 months	It is measured as the distance from the gingival margin to the mucogingival junction using williams periodontal probe
Clinical attachment level	Baseline and 6 months	Clinical attachment level is measured as the distance between a fixed point on the crown such as cementoenamel junction to the base of the pocket using williams periodontal probe