Placental Membrane for Root Coverage

Gingival Recession Clinical Trial

Official title:

Treatment of Gingival Recession Using a Coronally Advanced Flap Procedure With or Without Placental Membrane

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03053921
• Other study ID #: MADC/IRB/2015/94
• Status: Completed
• Phase: N/A
• First received: February 6, 2017
• Last updated: February 12, 2017
• Start date: August 19, 2015
• Est. completion date: June 15, 2016

Study information

• Verified date: January 2017
• Source: Meenakshi Ammal Dental College and Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 15, 2016
• Est. primary completion date: March 23, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 23 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Procedure:
• recession coverage
recession coverage done using Zuchellis technique
• recession coverage and membrane
recession coverage done using Zuchellis technique with placental membrane

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Meenakshi Ammal Dental College and Hospital

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical attachment level	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	Baseline and 6 months
Secondary	Width of Keratinized Gingiva	It is measured as the distance from the gingival margin to the mucogingival junction using williams periodontal probe	Baseline and 6 months