| CTRI Number |
CTRI/2025/09/094379 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Prevalance of trismus, Health related Quality of life and management among patients treated for oral surgical procedures at a tertiary care hostipal in coastal Karnataka |
|
Scientific Title of Study
|
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 Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prajna P Nayak |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Dental Sciences, Manipal |
| Address |
Room No.8, Department of Public Health Dentistry, Manipal College of Dental Sciences, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9986176634 |
| Fax |
|
| Email |
nayak.prajna@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Radhika Kapoor |
| Designation |
student |
| Affiliation |
Manipal College of Dental Sciences, Manipal |
| Address |
Room No. 308, NIH A block, MAHE hostels, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
09910533391 |
| Fax |
|
| Email |
radhikakapoor2003@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Radhika Kapoor |
| Designation |
student |
| Affiliation |
Manipal College of Dental Sciences, Manipal |
| Address |
Room No.8, Department of Public Health Dentistry, Manipal College of Dental Sciences, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
09910533391 |
| Fax |
|
| Email |
radhikakapoor2003@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No.8, Department of Public Health Dentistry, Manipal College of Dental Sciences, Manipal - 576104, Karnataka |
|
|
Primary Sponsor
|
| Name |
Prajna P Nayak |
| Address |
Room No.8, Department of Public Health Dentistry, Manipal College of Dental Sciences, Manipal - 576104 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prajna P Nayak |
Manipal College of Dental Sciences |
Room No.4, Department of Oral and Maxillofacial surgery, Manipal College of Dental Sciences, Manipal 576104
Udupi
KARNATAKA |
09986176634
nayak.prajna@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-1 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R290||Tetany, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients being treated for oral surgical procedures that can have trismus as a potential complications and Patients aged between 18-65 years |
|
| ExclusionCriteria |
| Details |
Patients with pharyngeal cancers, exclusive lip cancers, and Unwilling patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| prevalence of trismus among patients |
baseline - cross-sectional |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |