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Clinical Trials/CTRI/2025/09/094379
CTRI/2025/09/094379Not yet recruitingNot Applicable

Trismus prevalance, Health related Quality of life and management among patients treated for oral surgical procedures at a tertiary care hospital in coastal Karnataka

Prajna P Nayak1 site in 1 country500 target enrollmentStarted: October 10, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
500
Locations
1
Primary Endpoint
prevalence of trismus among patients

Study Overview

Brief Summary

This prospective cross-sectional study will be conducted in all Patients being treated for oral surgical procedures that can have trismus as a potential complication at MCODS, Manipal between August 2024 to July 2025. Permission will be taken from the Institutional Ethical Committee before proceeding with the study. Informed consent will be collected from all enrolled patients prior to data collection.

A self-administered questionnaire will be given to each patient who is being treated for oral surgical procedures that can have trismus as a potential complication at MCODS, Manipal.

Details on socio-demographic characteristics on patient’s age, gender, tobacco use, tumor site, and treatment modalities (surgical treatment, radiation, chemotherapy) will be first collected from the patient. The questionnaire will also contain Gothenburg Trismus Questionnaire - 2 (GTQ 2) (Johansson M et al., 2020) and Visual Analogue Scale (Gaston-Johansson F., 1996).

Inter-incisal

distance will then be measured. Inter-incisal

distance will be measured using digital caliper in millimeters Trismus will be classified based on criteria as mild (31-35 mm), moderate (26-30 mm) and severe (< 25 mm) (Thomas et al., 1988) In edentulous patients, distance between alveolus ridge was measured Quality of lifo is measured using a calibrated Visual Analog Scale with a choice of 0-100, from worst imaginable health state to best imaginable health state.

Gothenburg Trismus Questionnaire - 2 (GTQ 2) contains questions related to mouth opening and trismus.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients being treated for oral surgical procedures that can have trismus as a potential complications and Patients aged between 18-65 years.

Exclusion Criteria

  • Patients with pharyngeal cancers, exclusive lip cancers, and Unwilling patients.

Outcomes

Primary Outcomes

prevalence of trismus among patients

Time Frame: baseline - cross-sectional

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Prajna P Nayak
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Prajna P Nayak

Manipal College of Dental Sciences, Manipal

Study Sites (1)

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