| CTRI Number |
CTRI/2025/09/094003 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
30/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Examining how often serious jaw bone problems (osteoradionecrosis) happen and how well patients heal after tooth removal in people with head and neck cancer who have had radiation treatment, based on study data from a large hospital. |
|
Scientific Title of Study
|
Occurrence of Osteoradionecrosis and Healing Outcomes Following Dental Extractions in Head and Neck Cancer Patients Post-Radiotherapy in a Tertiary Health Care Centre: An Ambispective Cohort 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 Madhura Sharma |
| Designation |
Associate Professor |
| Affiliation |
Advanced Centre For Treatment Research, Education and Treatment in In Cancer Tata Memorial Centre |
| Address |
Advanced Centre For Treatment Research, Education and Treatment in Cancer - Tata Memorial Centre, Kharghar, Navi Mumbai.
Raigarh
MAHARASHTRA
410210
India |
| Phone |
09096046257 |
| Fax |
|
| Email |
sharmamadhura10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhura Sharma |
| Designation |
Associate Professor |
| Affiliation |
Advanced Centre For Treatment Research And Education In Cancer ACTREC |
| Address |
Dental Services, Room No 31, Sector 22, Advanced Centre of Treatment Research and Education in Cancer-Tata Memorial Centre, Utsav Chowk - CISF Rd, Owe Camp, Kharghar, Navi Mumbai.
Raigarh
MAHARASHTRA
410210
India |
| Phone |
09096046257 |
| Fax |
|
| Email |
sharmamadhura10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhura Sharma |
| Designation |
Associate Professor |
| Affiliation |
Advanced Centre For Treatment Research And Education In Cancer Actrec |
| Address |
Dental Services, Room No 31, Sector 22, Advanced Centre of Treatment Research and Education in Cancer-Tata Memorial Centre, Utsav Chowk - CISF Rd, Owe Camp, Kharghar, Navi Mumbai.
Raigarh
MAHARASHTRA
410210
India |
| Phone |
09096046257 |
| Fax |
|
| Email |
sharmamadhura10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)
Tata Memorial Centre
Kharghar, Navi Mumbai - 410210.
Maharashtra, India. |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Madhura Sharma |
Advance Centre for Treatment Research and Education in Cancer (ACTREC) |
Dental Services, Room No 31, Sector 22, Advanced Centre of Treatment Research and Education in Cancer-Tata Memorial Centre.
Raigarh
MAHARASHTRA |
09096046257
sharmamadhura10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee III |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C069||Malignant neoplasm of mouth, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
89.00 Year(s) |
| Gender |
Both |
| Details |
Histologically confirmed diagnosis of head and neck squamous cell carcinoma (SCC) or a salivary gland cancer (SGC). Patients who have received RT with curative intent (definitive or adjuvant), with or without concomitant chemotherapy;
Patients requiring or undergone extraction of one or more non-restorable teeth post-RT.
Patients with no evidence of disease or metastasis following RT. All adults, irrespective of race & ethnicity are eligible for this trial.
Ability to understand and the willingness to sign a written informed consent document |
|
| ExclusionCriteria |
| Details |
Active or recurrent HNC requiring ongoing treatment.Patients who have received palliative-intent head and neck RT, Uncontrolled systemic diseases, such as poorly managed diabetes or cardiovascular conditions, that may impair wound healing. Inability to attend follow-up visits or comply with post-extraction care recommendations. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome measures would be recorded depending on the evaluation of healing (soft tissue and bone healing) after dental extractions in patients who have undergone RT the for HNC. |
Evaluation of healing would be conducted at 3 months (baseline), 6 months and 12 months—aligned with the patient’s scheduled oncology follow-up visits—to assess healing at the extraction site and identify any potential complications. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="167"
Sample Size from India="167"
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)
|
15/09/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 cancer includes
different types, each with its own causes, symptoms, and treatments. According
to Globocan 2022, more than 805,000 new cases are reported worldwide every
year, leading to over 417,000 deaths. In India, this type of cancer is
especially common and requires intense treatment with a long recovery period.
Radiation therapy (RT) is a key
treatment for head and neck cancer, but it can have side effects like mouth
sores, dry mouth, trouble swallowing, and even damage to the jawbone (a
condition called osteoradionecrosis or ORN). ORN happens when radiation harms
the small blood vessels in the jaw, cutting off the bone’s supply of oxygen and
nutrients. This makes the bone weak and unable to heal properly, sometimes
leading to pain, infections, and even exposed bone that doesn’t heal. ORN can
develop months or even years after treatment.
To reduce the risk, doctors often
suggest removing unhealthy teeth before radiation and keeping a close watch on
dental health afterward. Usually, problematic teeth are taken out at least 14
days before treatment. However, there is some debate about whether teeth that
can’t be saved should also be removed after radiation. This study aims to
understand how well patients heal after dental extractions following RT and to
determine the safest timing for these procedures. |