Placental Membrane for Root Coverage
Primary Purpose
Gingival Recession
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
recession coverage
recession coverage and membrane
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession focused on measuring gingival recession, Zuchellis technique,, placental membrane
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
recession coverage
recession coverage and membrane
Arm Description
30 recession defects treated with Zucchelli's technique.
30 recession defects treated with Zucchelli's technique along with placental membrane.
Outcomes
Primary Outcome Measures
Height of Gingival recession
The height of gingival recession was measured from the cemento-enamel junction to the gingival margin using Williams periodontal probe
Secondary Outcome Measures
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
Width of Keratinized Gingiva
It is measured as the distance from the gingival margin to the mucogingival junction using williams periodontal probe
Full Information
NCT ID
NCT03053921
First Posted
February 6, 2017
Last Updated
February 12, 2017
Sponsor
Meenakshi Ammal Dental College and Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03053921
Brief Title
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
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
August 19, 2015 (Actual)
Primary Completion Date
March 23, 2016 (Actual)
Study Completion Date
June 15, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meenakshi Ammal Dental College and Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
gingival recession, Zuchellis technique,, placental membrane
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
recession coverage
Arm Type
Placebo Comparator
Arm Description
30 recession defects treated with Zucchelli's technique.
Arm Title
recession coverage and membrane
Arm Type
Active Comparator
Arm Description
30 recession defects treated with Zucchelli's technique along with placental membrane.
Intervention Type
Procedure
Intervention Name(s)
recession coverage
Other Intervention Name(s)
root coverage technique
Intervention Description
recession coverage done using Zuchellis technique
Intervention Type
Procedure
Intervention Name(s)
recession coverage and membrane
Other Intervention Name(s)
root coverage technique with membrane
Intervention Description
recession coverage done using Zuchellis technique with placental membrane
Primary Outcome Measure Information:
Title
Height of Gingival recession
Description
The height of gingival recession was measured from the cemento-enamel junction to the gingival margin using Williams periodontal probe
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Clinical attachment level
Description
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
Time Frame
Baseline and 6 months
Title
Width of Keratinized Gingiva
Description
It is measured as the distance from the gingival margin to the mucogingival junction using williams periodontal probe
Time Frame
Baseline and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah George, BDS
Organizational Affiliation
Meenakshi Ammal Dental College and Hospitals
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19563288
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.
Results Reference
background
PubMed Identifier
26501023
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.
Results Reference
background
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Placental Membrane for Root Coverage
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