- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03037320
Comparison of Coronally Advanced Flap and Semilunar Incision Vestibular Technique for Multiple Gingival Recessions in Maxillary Teeth - A Randomized Controlled Trial (CAF and SVIT)
January 31, 2017 updated by: Dr.Hema.P, Indira Gandhi Institute of Dental Science
Comparison of Coronally Advanced Flap and Semilunar Incision Vestibular Technique for Multiple Gingival Recessions in Maxillary Teeth - A Randomized Controlled
Comparison of Coronally advanced flap with semilunar vestibular incision technique for root coverage in patients with multiple gingival recession in maxillary teeth.
Study Overview
Status
Unknown
Conditions
Detailed Description
the subjects attending the OPD department of periodontology, IGIDS and patients will be selected based on inclusion criteria, informed consent to be obtained from the patients,
Randomization process:
- Patient to be selected for one of the two procedures by simple random sampling (Lottery method)
- Baseline value will be recorded by a calibrated examiner other than the operator
- The procedure is performed by the operator ( primary investigator)
- Post op values to be recorded by the calibrated examiner.
Patient to be reviewed at 3 and 6 months Results will be dicussed
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hema pichandi, BDS
- Phone Number: +91 9442804426
- Email: drhema6119@gmail.com
Study Contact Backup
- Name: Pratebha Balu, MDS
- Phone Number: +91 9894360543
- Email: pratebhabalu@igids.ac.in
Study Locations
-
-
-
Puducherry, India, 607402
- Recruiting
- Indira gandhi institute of dental sciences
-
Contact:
- Pratebha Balu, MDS
- Phone Number: +91 9894360543
- Email: pratebhabalu@igids.ac.in
-
Contact:
- Hema pichandi, BDS
- Phone Number: +91 9442804426
- Email: drhema6119@gamil.com
-
-
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
20 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males and females subjects of 20-50 years.
- Patients with multiple gingival recession (2-4 teeth) of class I & II in maxillary teeth.
- Patients with well aligned teeth
Exclusion Criteria:
- Patients with class III &IV gingival recession in maxillary teeth
- Recession in relation to molars
- Patients with systemic diseases
- Medically compromised patients
- Patient with history of smoking
- Patients with erosion and root caries
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: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: group A
root coverage to be performed by semilunar vestibular incision technique
|
|
Other: group B
root coverage by coronally advanced flap
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
amount of root coverage
Time Frame: 6 months
|
root coverage in millimeters
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
width of keratinised gingiva
Time Frame: 6 months
|
increase of width measured in millimeters
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
January 1, 2017
Primary Completion (Anticipated)
December 30, 2018
Study Completion (Anticipated)
December 30, 2018
Study Registration Dates
First Submitted
January 27, 2017
First Submitted That Met QC Criteria
January 30, 2017
First Posted (Estimate)
January 31, 2017
Study Record Updates
Last Update Posted (Estimate)
February 1, 2017
Last Update Submitted That Met QC Criteria
January 31, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IGIDSIEC2016NDP28PGHPPAI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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.
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