Comparison of Coronally Advanced Flap and Semilunar Incis... | NCT03037320

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

NCT03037320

Sponsor

Indira Gandhi Institute of Dental Science

Status

Unknown status

Last Update Posted

Feb 1, 2017Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Gingival Recession, Generalized
Root Coverage

Interventions

comparison of coronally advanced flap and semilunar vestibular incision technique for root coverage in maxillary teeth

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017Actual

Primary Completion Date

Dec 30, 2018Estimated

Completion Date

Dec 30, 2018Estimated

First Submitted Date

Jan 27, 2017

First Submission Date that Met QC Criteria

Jan 30, 2017

First Posted Date

Jan 31, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 31, 2017

Last Update Posted Date

Feb 1, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr.Hema.P, post graduate student, Indira Gandhi Institute of Dental SciencePrincipal Investigator

Lead Sponsor

Indira Gandhi Institute of Dental ScienceOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group A	Experimental	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	Other	root coverage by coronally advanced flap	Procedure: comparison of coronally advanced flap and semilunar vestibular incision technique for root coverage in maxillary teeth

Interventions

Name	Type	Description	Arm Group Labels	Other Names
comparison of coronally advanced flap and semilunar vestibular incision technique for root coverage in maxillary teeth	Procedure		group A group B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
amount of root coverage	root coverage in millimeters	6 months

Secondary Outcomes

Measure	Description	Time Frame
width of keratinised gingiva	increase of width measured in millimeters	6 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hema pichandi, BDS	Contact	9442804426	+91	drhema6119@gmail.com
Pratebha Balu, MDS	Contact	9894360543	+91	pratebhabalu@igids.ac.in

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Indira Gandhi Institute of dental sciences	Recruiting	Puducherry	Puducherry	607402	India

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D005882	Gingival Diseases
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D055093	Periodontal Atrophy