Trismus prevalance, Health related Quality of life and management among patients treated for oral surgical procedures at a tertiary care hospital in coastal Karnataka
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
Dr Prajna P Nayak
Manipal College of Dental Sciences, Manipal
