Back to resultsComparison of Coronally Advanced Flap and Semilunar Incision Vestibular Technique for Multiple Gingival Recessions in Maxillary Teeth - A Randomized Controlled Trial (CAF and SVIT)
Primary Purpose
Gingival Recession, Generalized, Root Coverage
Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
comparison of coronally advanced flap and semilunar vestibular incision technique for root coverage in maxillary teeth
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession, Generalized
Eligibility Criteria
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
Sites / Locations
- Indira Gandhi Institute of dental sciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
group A
group B
Arm Description
root coverage to be performed by semilunar vestibular incision technique
root coverage by coronally advanced flap
Outcomes
Primary Outcome Measures
amount of root coverage
root coverage in millimeters
Secondary Outcome Measures
width of keratinised gingiva
increase of width measured in millimeters
Full Information
NCT ID
NCT03037320
First Posted
January 27, 2017
Last Updated
January 31, 2017
Sponsor
Indira Gandhi Institute of Dental Science
1. Study Identification
Unique Protocol Identification Number
NCT03037320
Brief Title
Comparison of Coronally Advanced Flap and Semilunar Incision Vestibular Technique for Multiple Gingival Recessions in Maxillary Teeth - A Randomized Controlled Trial
Acronym
CAF and SVIT
Official Title
Comparison of Coronally Advanced Flap and Semilunar Incision Vestibular Technique for Multiple Gingival Recessions in Maxillary Teeth - A Randomized Controlled
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 30, 2018 (Anticipated)
Study Completion Date
December 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indira Gandhi Institute of Dental Science
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
Comparison of Coronally advanced flap with semilunar vestibular incision technique for root coverage in patients with multiple gingival recession in maxillary teeth.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession, Generalized, Root Coverage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group A
Arm Type
Experimental
Arm Description
root coverage to be performed by semilunar vestibular incision technique
Arm Title
group B
Arm Type
Other
Arm Description
root coverage by coronally advanced flap
Intervention Type
Procedure
Intervention Name(s)
comparison of coronally advanced flap and semilunar vestibular incision technique for root coverage in maxillary teeth
Primary Outcome Measure Information:
Title
amount of root coverage
Description
root coverage in millimeters
Time Frame
6 months
Secondary Outcome Measure Information:
Title
width of keratinised gingiva
Description
increase of width measured in millimeters
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hema pichandi, BDS
Phone
9442804426
Ext
+91
Email
drhema6119@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Pratebha Balu, MDS
Phone
9894360543
Ext
+91
Email
pratebhabalu@igids.ac.in
Facility Information:
Facility Name
Indira Gandhi Institute of dental sciences
City
Puducherry
ZIP/Postal Code
607402
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hema pichandi, BDS
Phone
9442804426
Ext
+91
Email
drhema6119@gamil.com
First Name & Middle Initial & Last Name & Degree
Pratebha Balu, MDS
Phone
9894360543
Ext
+91
Email
pratebhabalu@igids.ac.in
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Comparison of Coronally Advanced Flap and Semilunar Incision Vestibular Technique for Multiple Gingival Recessions in Maxillary Teeth - A Randomized Controlled Trial
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