| CTRI Number |
CTRI/2025/10/096671 [Registered on: 30/10/2025] Trial Registered Prospectively |
| Last Modified On: |
30/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on Bite Strength and Comfort After Jaw Reconstruction With Artificial Teeth |
|
Scientific Title of Study
|
Maximum Bite Force And Patient Satisfaction After Prosthetic Rehabilitation In Patients with Segmental Mandibulectomy: Cross Sectional, Observational 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 Sandeep Gurav |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Room No. 220, Department of Dental and Prosthetic Surgery, Second Floor, Homi Bhabha Block,
Tata Memorial Hospital
Dr. Ernest Borges Road, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9769387712 |
| Fax |
|
| Email |
drsandeepgurav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Gurav |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Room No. 220, Department of Dental and Prosthetic Surgery, Second Floor, Homi Bhabha Block,
Tata Memorial Hospital
Dr. Ernest Borges Road, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9769387712 |
| Fax |
|
| Email |
drsandeepgurav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Gurav |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Room No. 220, Department of Dental and Prosthetic Surgery, Second Floor, Homi Bhabha Block,
Tata Memorial Hospital
Dr. Ernest Borges Road, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9769387712 |
| Fax |
|
| Email |
drsandeepgurav@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
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 |
| Dr Sandeep Gurav |
Tata Memorial Hospital |
Room No. 220, Department of Dental and Prosthetic Surgery, Second Floor, Homi Bhabha Block
Dr. Ernest Borges Road, Parel, Mumbai, 400012
Mumbai
MAHARASHTRA |
9769387712
drsandeepgurav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Centre Instituitional Ethics Committee I |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C031||Malignant neoplasm of lower gum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Disease free individuals who are treated for oral cancer within the age group of 18-70 years.
2. Patients who underwent prosthetic rehabilitation after segmental mandibulectomy with or without resconstruction.
3. Patients who have opposing natural or rehabilitated dentition.
4. The patients who are willing to give consent and able to complete study assessments, and other requirements. |
|
| ExclusionCriteria |
| Details |
1.Patients with neuromuscular and TMJ disease.
2.Patient with severe trismus.
3.Those patients who cannot achieve occlusion with manual manipulation.
4.Those patients who underwent segmental mandibulectomy with and without reconstruction and have never received a prosthesis. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. The primary outcome of this study is the measurement of the mean maximum bite force (MMBF) in patients who underwent prosthetic rehabilitation following SM with and without reconstruction.
2. The co-primary outcome of this study is the comparison of the mean maximum bite force (MMBF) in patients with segmental mandibulectomy with and without reconstruction.
|
0 to 12 Months: Patient screening, consenting, recruitment and collection of data
12-18 Months: Compilation of data, statistical analysis and publication.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Comparison of the chewing efficiency amongst patients using implant supported prosthesis (ISP) following free fibula reconstruction (FFOCF) after SM to patients without osseous reconstruction and rehabilitated with guide bite prosthesis (GBP).
2. Measurement of patient satisfaction by means of QOL measurement using LORQv3 questionnaire.
3. Qualitative analysis to assess experiences of head and neck cancer (HNC) survivors with segmental mandibulectomy, specifically how prosthetic rehabilitation affected their lives, and healthcare experiences.
|
0 to 12 Months: Patient screening, consenting, recruitment and collection of data
12-18 Months: Compilation of data, statistical analysis and publication.
|
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
10/11/2025 |
| 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="6"
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
|
Maximum bite force and patient satisfaction after dental and prosthetic rehabilitation in patients with segmental mandibulectomy: cross sectional, observational study Tumor of lower jaw bone often requires surgery to remove the affected jaw bone (mandible), muscle and teeth. Then the removed part is reconstructed either with bone, muscle and skin from the leg (Free fibula flap) or with muscle and skin from the chest or thigh (soft tissue flap). These patients lose their teeth during the surgery. The replacement of teeth for patients whose jaw is built with bone is done with the help of a dental implant, a titanium made screw like fixture which remains embedded inside the bone. Removable dentures or fixed teeth are then given with the support of the implants placed in the jaw bone. For patients whose jaw is built with soft tissue only, the remaining jaw has a tendency to shift to the side of surgery. Such patients are given a clip that helps to bring the remaining jaw back into position (guide bite prosthesis). The effectiveness of these kind of prostheses has not been evaluated earlier. To check the same, the force generated by upper and lower teeth (known as bite force) will be measured and recorded. A bite force that is higher would indicate better chewing. The chewing ability with these implant supported prosthesis and guide bite prosthesis will also be measured with a chewing gum. Therefore, the purpose of the study is to measure the bite force for patients rehabilitated with bone and soft tissue flap and to evaluate the chewing efficiency for these group of patients. An instrument that is used to measure the bite force (bite force transducer) would be used to measure the bite force in both group of patients during the follow up visit to the hospital. |