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Clinical Trials/CTRI/2024/04/066361
CTRI/2024/04/066361
Not yet recruiting
Phase 2/3

Comparative assessment of effectiveness of uni-arch soft splint and bi-arch soft splint in patients with temporomandibular disorders using helkimo index analysis.

Ashwinthan M1 site in 1 country48 target enrollmentStarted: May 25, 2024Last updated:
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Overview

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Ashwinthan M
Enrollment
48
Locations
1
Primary Endpoint
No clinical dysfunction of and no symptoms after splint therapy for temporomandibular disorder patients
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

Clinical trial has been performed to evaluate the effectiveness of soft splint for patients who are suffering from temporomandibular disorders. Two Group were chosen GROUP A and GROUP B  In GROUP A, uni arch splint or single arch splint is given to tmd patients and recovery is evaluated using Helkimo index In GROUPB, bi arch splint or double arch splint is given to tmd patients and recovery is evaluated using same Helkimo index The study duration will be conducted for three months.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 50.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Patients who are clinically diagnosed with temporomandibular disorder.
  • •Patients those who are willing to participate in the study.

Exclusion Criteria

  • •Patients with only clicking sounds and without pain.
  • •Patients who are allergic to muscle relaxants medicine.
  • •Patients with severe trauma with tmj fracture.
  • •Patients who are pregnant or lactating.
  • •Patients who are above age group
  • •Patients who are not willing to participate in the study.
  • •Patients who have gastritis, peptic or duodenal ulcers.

Outcomes

Primary Outcomes

No clinical dysfunction of and no symptoms after splint therapy for temporomandibular disorder patients

Time Frame: 12 weeks

Secondary Outcomes

  • Returning jaw position and reducing excess jaw load(1 month)

Investigators

Sponsor
Ashwinthan M
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr AshwinthanM

tamil nadu MGR University

Study Sites (1)

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