Placental Membrane for Root Coverage
February 12, 2017 updated by: Dr.Jaideep Mahendra, Meenakshi Ammal Dental College and Hospital
Treatment of Gingival Recession Using a Coronally Advanced Flap Procedure With or Without Placental Membrane
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
.
CLINICAL PARAMETERS:
- Probing Pocket Depth(PPD)
- Clinical Attachment Level(CAL)
- Height of Gingival Recession(HGR)
- Width of Gingival Recession(WGR)
- Width of Keratinized Gingiva(WKG) The clinical parameters were assessed & recorded on 0 day, 90th day and 180th day
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
23 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: recession coverage
30 recession defects treated with Zucchelli's technique.
|
recession coverage done using Zuchellis technique
Other Names:
|
|
Active Comparator: recession coverage and membrane
30 recession defects treated with Zucchelli's technique along with placental membrane.
|
recession coverage done using Zuchellis technique with placental membrane
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Height of Gingival recession
Time Frame: 6 months
|
The height of gingival recession was measured from the cemento-enamel junction to the gingival margin using Williams periodontal probe
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical attachment level
Time Frame: 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
|
Baseline and 6 months
|
|
Width of Keratinized Gingiva
Time Frame: Baseline and 6 months
|
It is measured as the distance from the gingival margin to the mucogingival junction using williams periodontal probe
|
Baseline and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sarah George, BDS, Meenakshi Ammal Dental College and Hospitals
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 19, 2015
Primary Completion (Actual)
March 23, 2016
Study Completion (Actual)
June 15, 2016
Study Registration Dates
First Submitted
February 6, 2017
First Submitted That Met QC Criteria
February 12, 2017
First Posted (Actual)
February 15, 2017
Study Record Updates
Last Update Posted (Actual)
February 15, 2017
Last Update Submitted That Met QC Criteria
February 12, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MADC/IRB/2015/94
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.