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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  
Name  Address 
NIL   
 
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  
Status 
Not Applicable 
 
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.

 
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