Clinical trial NCT03053921: Placental Membrane for Root Coverage
Official title: Treatment of Gingival Recession Using a Coronally Advanced Flap Procedure With or Without Placental Membrane
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Keywords: gingival recession
Zuchellis technique,
placental membrane
Lead sponsor: Meenakshi Ammal Dental College and Hospital
Sponsor class: OTHER
First posted: 2017-02-15
Enrollment: 15
Sex: ALL
Minimum age (years): 23
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Height of Gingival recession
timeFrame: 6 months
Secondary outcomes:
measure: Clinical attachment level
timeFrame: Baseline and 6 months
measure: Width of Keratinized Gingiva
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Meenakshi Ammal Dental College and Hospitals
name: Sarah George, BDS
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.