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Comparison of Coronally Advanced Flap and Semilunar Incision Vestibular Technique for Multiple Gingival Recessions in Maxillary Teeth - A Randomized Controlled Trial (CAF and SVIT)

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ClinicalTrials.gov Identifier: NCT03037320
Recruitment Status : Unknown
Verified January 2017 by Dr.Hema.P, Indira Gandhi Institute of Dental Science.
Recruitment status was:  Recruiting
First Posted : January 31, 2017
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
Dr.Hema.P, Indira Gandhi Institute of Dental Science

Brief Summary:
Comparison of Coronally advanced flap with semilunar vestibular incision technique for root coverage in patients with multiple gingival recession in maxillary teeth.

Condition or disease Intervention/treatment Phase
Gingival Recession, Generalized Root Coverage Procedure: comparison of coronally advanced flap and semilunar vestibular incision technique for root coverage in maxillary teeth Not Applicable

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:

  1. Patient to be selected for one of the two procedures by simple random sampling (Lottery method)
  2. Baseline value will be recorded by a calibrated examiner other than the operator
  3. The procedure is performed by the operator ( primary investigator)
  4. Post op values to be recorded by the calibrated examiner.

Patient to be reviewed at 3 and 6 months Results will be dicussed


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Coronally Advanced Flap and Semilunar Incision Vestibular Technique for Multiple Gingival Recessions in Maxillary Teeth - A Randomized Controlled
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : December 30, 2018

Arm Intervention/treatment
Experimental: group A
root coverage to be performed by semilunar vestibular incision technique
Procedure: comparison of coronally advanced flap and semilunar vestibular incision technique for root coverage in maxillary teeth
group B
root coverage by coronally advanced flap
Procedure: comparison of coronally advanced flap and semilunar vestibular incision technique for root coverage in maxillary teeth



Primary Outcome Measures :
  1. amount of root coverage [ Time Frame: 6 months ]
    root coverage in millimeters


Secondary Outcome Measures :
  1. width of keratinised gingiva [ Time Frame: 6 months ]
    increase of width measured in millimeters



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037320


Contacts
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Contact: Hema pichandi, BDS 9442804426 ext +91 drhema6119@gmail.com
Contact: Pratebha Balu, MDS 9894360543 ext +91 pratebhabalu@igids.ac.in

Locations
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India
Indira Gandhi Institute of dental sciences Recruiting
Puducherry, India, 607402
Contact: Hema pichandi, BDS    9442804426 ext +91    drhema6119@gamil.com   
Contact: Pratebha Balu, MDS    9894360543 ext +91    pratebhabalu@igids.ac.in   
Sponsors and Collaborators
Indira Gandhi Institute of Dental Science

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Responsible Party: Dr.Hema.P, post graduate student, Indira Gandhi Institute of Dental Science
ClinicalTrials.gov Identifier: NCT03037320     History of Changes
Other Study ID Numbers: IGIDSIEC2016NDP28PGHPPAI
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Gingival Recession
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy