| CTRI Number |
CTRI/2024/02/062642 [Registered on: 14/02/2024] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assesment of Lower jaw deviation pattern in oral cancer following surgery |
|
Scientific Title of Study
|
Evaluation of the Deviation pattern following Mandibulectomy for Oral Cancer Patients - A Prospective 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 Pankaj Chauhan |
| Designation |
Associate Professor |
| Affiliation |
Homi Bhabah Cancer Hospital and Research Centre |
| Address |
Room No 128 & 129
Department of Dental and Prosthetics Surgery
Homi Bhabha Cancer Hospital and Research Centre Visakhapatnam
Visakhapatnam ANDHRA PRADESH 530053 India |
| Phone |
8178224559 |
| Fax |
|
| Email |
dr.prachichauhan@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Pankaj Chauhan |
| Designation |
Associate Professor |
| Affiliation |
Homi Bhabah Cancer Hospital and Research Centre |
| Address |
Room No 128 & 129
Department of Dental and Prosthetics Surgery
Homi Bhabha Cancer Hospital and Research Centre Visakhapatnam
Visakhapatnam ANDHRA PRADESH 530053 India |
| Phone |
8178224559 |
| Fax |
|
| Email |
dr.prachichauhan@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Pankaj Chauhan |
| Designation |
Associate Professor |
| Affiliation |
Homi Bhabah Cancer Hospital and Research Centre |
| Address |
Room No 128 & 129
Department of Dental and Prosthetics Surgery
Homi Bhabha Cancer Hospital and Research Centre Visakhapatnam
Visakhapatnam ANDHRA PRADESH 530053 India |
| Phone |
8178224559 |
| Fax |
|
| Email |
dr.prachichauhan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Homi Bhabha Cancer Hospital and Research Centre Vishakhapatnam |
|
|
Primary Sponsor
|
| Name |
Homi Bhabha Cancer Hospital and Research Centre |
| Address |
Homi Bhabah Cancer Hospital and Research Centre Visahkapatnam
Agnampudi
Visakhapatnam
Andhra pradesh
530053
Agnampudi
Visakhapatnam |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Pankaj Chauahn |
Homi Bhabah Cancer Hospital and Research Centre |
Room No 128 & 129
Department of Dental and Prosthetics Surgery
Visakhapatnam
ANDHRA PRADESH Visakhapatnam ANDHRA PRADESH |
8178224559
dr.prachichauhan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C03||Malignant neoplasm of gum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Consecutive, adult oral cancer patients of all socioeconomic strata, 18-70 years age range who are planned to undergo resection of the mandible (± upper alveolus) for oral cancer and reconstruction with the soft tissue flap.
2. Have a total of 6 or more teeth in the planned non-resected side of jaw
3. Have a mouth opening of at least 1.5 cm before surgery
|
|
| ExclusionCriteria |
| Details |
1. Patients with planned major composite surgeries like subtotal/total glossectomy or total maxillectomy limiting oral function.
2. Planned Jaw reconstruction with bone/reconstruction plate and
3. Planned marginal mandibulectomy cases.
4. Non-consenting patient
5. Recurrence cases
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure the deviation pattern following mandibulectomy for oral cancer patients reconstructed with soft tissue flap |
Baseline
1 week after Surgery
Before radiation or1 month after surgery
After radiation or 3 months after surgery
6 months after surgery
9 months after surgery
12 months after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To measure and correlate the pattern of mandibular deviation to the extent of defect in segmental mandibulectomy the type of soft tissue flaps used for reconstruction and the effect of adjuvant radiation treatment.
To evaluate and compare the deviation pattern in segmental mandibulectomy patients at different time points.
Chewing efficiency comparison at different time points following surgery and adjuvant radiation.
Chewing efficiency comparison in segmental mandibulectomy patients with the extent of the defect adjuvant radiation treatment and types of flap reconstructions.
QOL comparison at different time points.
QOL comparison at different time points in segmental mandibulectomy patients in segmental mandibulectomy patients with the extent of the defect adjuvant radiation treatment and types of flap reconstructions.
Percentage efficiency of GBP prosthesis in deviation correction.
|
Baseline
1 week after Surgery
Before radiation or1 month after surgery
After radiation or 3 months after surgery
6 months after surgery
9 months after surgery
12 months after surgery |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
26/02/2024 |
| 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="2" 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
|
Post-mandibulectomy
rehabilitation involves a multidisciplinary approach which includes surgical
reconstruction with bone/ reconstruction plate, the use of guide bite
prosthesis and dental rehabilitation, and physical therapy depending on the
clinical situation and patients’ individual needs.
Research gap: Since patients with segmental mandibulectomy
defect and soft tissue reconstruction represent a major cohort of
mandibulectomy patients and no literature is present describing the amount of
mandibular deviation in these patients, its correlation with the extent of the
size of the surgical defect, type of soft tissue reconstruction, period elapsed
from the surgery, and adjuvant treatment, use of guidance prosthesis. No
guidance literature is present regarding how much time the guidance prosthesis
should be used in these mandibulectomy patients. Prospective clinical studies
can provide valuable insights into this complication’s prevalence, severity,
and potential predictors.
The study aims to evaluate the Deviation pattern following Mandibulectomy for
Oral Cancer Patients.
The primary
objective is to measure the deviation pattern following mandibulectomy for oral
cancer patients reconstructed with soft tissue flap.
All patients who are planning to undergo mandibulectomy for
oral cancer will be eligible to participate in this study. Patient demographics
including age, stage, treatment details of the surgery, reconstruction details,
adjuvant radiotherapy, and/or chemotherapy will be retrieved from the case
records and/or EMR. Hospital-based “Electronic Medical Record†will be reviewed
to enter the clinical details.
Outcome evaluation would quantify the degree of
deviation in millimeters and assess the prevalence and severity of mandibular
deviation at various time intervals following surgery and will be compared with
the baseline data before surgery. The deviations will be compared based on
factors like the extent of the defect, radiation treatment, and prosthesis use.
Chewing performance would be evaluated by the mixing ability. The chewing
efficiency of study participants will be evaluated and compared between
different subgroups based on the mentioned factors. The Quality of life would
be evaluated by the EORTC QLQ-C30 and H&N35 questionnaires. The outcome would assess the impact of
mandibular deviation on the overall quality of life of participants and analyze
differences in quality of life scores based on the time elapsed since surgery, the
extent of the defect, radiation treatment, and prosthesis use. The outcome
would also analyze the effect of guide bite prosthesis usage on mandibular
deviation, chewing efficiency, and quality of life by comparing outcomes
between users at different time points.
By measuring these outcomes and considering the
mentioned factors, this study can provide valuable insights into how mandibular
deviation impacts patients’ lives and how various factors influence this
deviation, chewing efficiency, and overall quality of life following
mandibulectomy. |