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Clinical Trials/CTRI/2024/10/075771
CTRI/2024/10/075771RecruitingNot Applicable

Comparision of Conventional scalpel fibrotomy versus Diode laser fibrotomy in Oral submucous fibrosis - A Prospective study

Jaya Aishwariyagha S1 site in 1 country20 target enrollmentStarted: October 30, 2024Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
20
Locations
1
Primary Endpoint
To assess the Mouth opening following fibrotomy
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Title - Comparision of Conventional Scalpel Fibrotomy versus Diode laser fibrotomy in oral submucous fibrosis - A Prospective study

Age: No age limit

Gender: No gender prediliction

Inclusion criteria: Mouth opening of 26-35mm(stage 2) and 15-25mm(stage3) - Khanna JN and Andrade classification

Exclusion criteria: Patient who cannot stop the habit; Uncooperative and medically compromised patients

Methods: Group A- Surgical blade fibrotomy (10 patients)

Group B- Diode laser fibrotomy (10 patients)

Follow up: 6 months

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
None

Eligibility Criteria

Ages
20.00 Year(s) to 80.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Limited mouth opening of 26-35mm and 15-25mm: Khanna JN and Andrade classification Patient who already underwent intralesional therapy.

Exclusion Criteria

  • •Patient who are unable to stop the habit.
  • •Medically compromised and uncooperative patients.

Outcomes

Primary Outcomes

To assess the Mouth opening following fibrotomy

Time Frame: 6 months follow up- post op 1st day,3rd day,7 th day and on 1st,3rd and 6th month

Secondary Outcomes

  • To assess healing,pain,swelling and compare between two groups.(Follow up - Post op 1st day,3rd day,7 th day)

Investigators

Sponsor
Jaya Aishwariyagha S
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Jaya Aishwariyagha S

Thai moogambigai dental college

Study Sites (1)

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