| CTRI Number |
CTRI/2025/05/086245 [Registered on: 05/05/2025] Trial Registered Prospectively |
| Last Modified On: |
03/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Oral Health in patients with head and neck cancer before radiation therapy |
|
Scientific Title of Study
|
Oral Health Status in patients with Head and Neck Cancer prior to Radiotherapy: A Cross-Sectional Study |
| 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 Bhanu Priya |
| Designation |
PG Student |
| Affiliation |
Manipal College of Dental Sciences, Manipal |
| Address |
Department of Oral Medicine and Radiology Manipal College of Dental Sciences Manipal Madhav Nagar Eshwar Nagar 576104
Udupi
KARNATAKA
576104
India |
| Phone |
07006514715 |
| Fax |
|
| Email |
bhanu.mcodsmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhanu Priya |
| Designation |
PG Student |
| Affiliation |
Manipal College of Dental Sciences, Manipal |
| Address |
Department of Oral Medicine and Radiology Manipal College of Dental Sciences Manipal Madhav Nagar Eshwar Nagar 576104
Udupi
KARNATAKA
576104
India |
| Phone |
07006514715 |
| Fax |
|
| Email |
bhanu.mcodsmpl2023@learner.manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhanu Priya |
| Designation |
PG Student |
| Affiliation |
Manipal College of Dental Sciences, Manipal |
| Address |
Department of Oral Medicine and Radiology Manipal College of Dental Sciences Manipal Madhav Nagar Eshwar Nagar 576104
Udupi
KARNATAKA
576104
India |
| Phone |
07006514715 |
| Fax |
|
| Email |
bhanu.mcodsmpl2023@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr. Bhanu Priya |
| Address |
Manipal College of Dental Sciences,Manipal,Manipal Academy of Higher Education,Madhav Nagar,Eshwar Nagar Manipal, Karnataka 576104 |
| Type of Sponsor |
Other [Self funded] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Naveena Kumar AN |
Kasturba Medical College Madhav Nagar Eshwar Nagar Manipal 576104 |
Department of Surgical Oncology
Udupi
KARNATAKA |
9969523579
naveenkumar.an@manipal.edu |
| Dr Shirley Lewis |
Kasturba Medical College Madhav Nagar Eshwar Nagar Manipal 576104 |
Department of Radiation Oncology
Udupi
KARNATAKA |
9969557231
shirley.salins@manipal.edu |
| Dr Bhanu Priya |
Manipal College of Dental Sciences, Manipal |
Department of Oral Medicine and Radiology,Manipal College of Dental Sciences,Manipal, Room No-1
Udupi
KARNATAKA |
7006514715
bhanu.mcodsmpl2023@learner.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-2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C01||Malignant neoplasm of base of tongue, (2) ICD-10 Condition: C049||Malignant neoplasm of floor of mouth, unspecified, (3) ICD-10 Condition: C109||Malignant neoplasm of oropharynx,unspecified, (4) ICD-10 Condition: C059||Malignant neoplasm of palate, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All dentate patients above 18 years of age, diagnosed with head and neck cancer who are untreated or surgically treated and are scheduled for radiotherapy and are willing to participate in the study shall be included. |
|
| ExclusionCriteria |
| Details |
) Patients below 18 years shall be excluded from the study 2) Patients who are not willing to participate in the study shall be excluded 3) Patients suffering from other systemic diseases, who are under long-term medications for systemic illnesses, diagnosed with psychiatric conditions that might affect the participation of the study shall be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| assess the oral health status of patients diagnosed with head and neck cancers awaiting radiotherapy. |
Baseline and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| highlights the risk factors contributing to oral health deterioration in head & neck cancer patients undergoing radiotherapy & evaluates the effectiveness of pre-radiotherapy dental treatment plans in maintaining oral health. |
Baseline & 6 months |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
15/05/2025 |
| 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
|
Head and neck cancers of the oral cavity, pharynx, and larynx are among the most common types of cancers reported in our country. Tobacco use, particularly smoking and smokeless tobacco consumption, is a significant risk factor. Consumption of tobacco in smokeless form is especially widespread in India and has been linked to oral cancers, which is a significant subset of head and neck cancer. Radiotherapy, a common treatment for these cancers, is associated with severe oral and dental side effects, such as xerostomia and osteoradionecrosis, which can cause significant morbidity and impact a patient’s quality of life by affecting functions like chewing, swallowing, and speaking. This study aims to assess the oral health status of head and neck cancer patients before radiotherapy, investigate the prevalence of associated risk factors for poor oral health and to assess the treatment outcome on 6 months follow-up basis. The findings could help in developing targeted dental treatment plans to mitigate the adverse effects of radiotherapy, ultimately improving patient outcomes and quality of life. Participants aged 18+ with head and neck cancer, untreated or post-surgery and scheduled for radiotherapy, visiting the Department of Oral Medicine and Radiology, will be recruited after informed consent (English/Kannada). The study protocol will undergo Department, Institutional, and KH Ethics Committee review, with CTRI registration will be done Data collection will include case history, demographics, medical history, oral habits, and standardized oral examination following WHO guidelines. Data will be entered in Excel and analyzed using SPSS v23 with descriptive statistics and Chi-square tests. |