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CTRI Number  CTRI/2024/08/072822 [Registered on: 21/08/2024] Trial Registered Prospectively
Last Modified On: 24/10/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   PROSPECTIVE OBSERVATIONAL STUDY 
Study Design  Other 
Public Title of Study   To evaluate cost and benefit of dental implant-supported removable denture prosthesis treatment in head and neck cancer patients.  
Scientific Title of Study   Cost-benefit analysis of dental implant-supported overdenture treatment in head and neck cancer patients. 
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 Centre 
Address  Department of Dental and Prosthetic Surgery Homi Babha Building, Dr Ernest Borges Rd, Parel east

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177224  
Fax    
Email  drsandeepgurav@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sandeep Gurav 
Designation  Professor 
Affiliation  Tata Memorial Centre 
Address  Department of Dental and Prosthetic Surgery Homi Babha Building, Dr Ernest Borges Rd, Parel east


MAHARASHTRA
400012
India 
Phone  02224177224  
Fax    
Email  drsandeepgurav@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sauptik Ray 
Designation  Fellow 
Affiliation  Tata Memorial Centre 
Address  Department of Dental and Prosthetic Surgery Homi Babha Building, Dr Ernest Borges Rd, Parel east

Mumbai
MAHARASHTRA
400012
India 
Phone  09902054678  
Fax    
Email  sauptikray93@gmail.com  
 
Source of Monetary or Material Support  
TATA MEMORIAL HOSPITAL Dr. E Borges Road, Parel Mumbai Maharashtra India Pincode-400012  
 
Primary Sponsor  
Name  TATA MEMORIAL HOSPITAL 
Address  Dr Ernest Borges Rd, Parel Mumbai Maharashtra India Pincode 400012 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  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 SANDEEP GURAV  Tata Memorial Hospital   Department of Dental and Prosthetic Surgery Homi Babha Building HBB 217 Golden Jubliee Building GJB 130 Dr Ernest Borges Rd, Parel Mumbai Maharashtra India 400012
Mumbai
MAHARASHTRA 		 02224177224

drsandeepgurav@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata memorial hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Consecutive, disease-free, consenting 18 – 75 years old head and neck cancer patients of all socio-economic strata who:
a) Are planned to receive implant-supported overdenture prosthesis replacing 8 or more missing teeth in the native maxilla/mandible or jaw reconstructed with free fibular flap.
b) Patients who have undergone dental implant insertion surgery and planned for implant supported overdenture.
c) Patients who shall be using dentures for first time
d) Have 12 or more teeth, either natural or prosthetically replaced in the opposite arch.
e) Patients who can understand and fill Oral health impact profile questionnaire (OHIP-14) and Liverpool oral rehabilitation questionnaire (LORQOLv3) in English or translated versions. 
 
ExclusionCriteria 
Details  a) Patients with major intra-oral defects such as total or near total glossectomy.
b) Patients who have undergone bite composite resection with or without reconstruction with an osseous flap.
c)Patients with posterior segmental mandibulectomy without osseous reconstruction.
d) Systemic contraindications for dental implant treatment such as recent myocardial infarction and cerebrovascular accident, uncontrolled diabetes, bleeding disorder, patients on antiresorptive medications and immunocompromised patients.
e) Patients who are using implant supported prosthesis and requires replacement of prosthesis  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Total cost of rehabilitation
2. Effectiveness
 		 3+/-1 months after prosthesis fabrication  
 
Secondary Outcome  
Outcome  TimePoints 
Mixing Ability Test  before prosthesis fabrication and 3-4 months after implant overdenture treatment. 
Patient-perceived treatment satisfaction will be evaluated using Liverpool Oral Rehabilitation Questionnaire (LORQv4) scores   before prosthesis fabrication and 3-4 months after implant overdenture treatment. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   02/09/2024 
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)
Modification(s)  		 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  

AIM: To conduct a cost-benefit analysis of dental implant supported overdenture treatment in head and neck cancer patients.

 

PRIMARY OBJECTIVE:

  1. To find the Cost in rupees needed for each point gain in the quality of life with dental implant-supported overdenture treatment in both native jaw and free fibular flap reconstructed jaw.

 

 

SECONDARY OBJECTIVES: 

  1. To measure Quality-adjusted life years (QALYs) by assessing change in the oral health-related quality of life using the Oral health impact profile questionnaire (OHIP-14) before fabrication of prosthesis and 3 ± 1 months after placement of overdenture. 
  2. To evaluate the change in functional outcome using mixing ability test before fabrication of prosthesis and 3 ± 1 month after placement of overdenture. 
  3. To evaluate patient-perceived treatment satisfaction using Liverpool oral rehabilitation questionnaire (LORQOLv3) before fabrication of prosthesis and 3 ± 1 month after placement of overdenture.

STUDY METHODOLOGY
  1. Patients who satisfy the aforementioned inclusion criteria will be approached for study participation and accrued after they provide written informed consent for the present study. which shall be taken from the patient before fabrication of prosthesis and patients shall be given 24 hours to decide.
  1. Dental implants are standard care offered at Tata Memorial Hospital where implants are either placed primarily or secondarily.
  1. For patients who has underwent adjuvant radiotherapy, dental implant treatment is done 1 year    after completion of radiation therapy as per institutional policy. 
  2. Implants are loaded according to institute protocol i.e., receive overdenture prosthesis after 3 and 6 months in non- irradiated and irradiated patients respectively, to allow sufficient time for the implants to Osseo integrate  
  3. Patient’s relevant demographic characteristics will be noted. Necessary information shall be collected from Patient’s files and hospital electronic medical records/interview of patients.
  4. Quality of life data i.e., Oral health impact profile-14 questionnaire and Liverpool oral rehabilitation questionnaire version 3 will be recorded before prosthesis fabrication and 3 ± 1 months after completion of treatment.
  5. Patients’ chewing or masticatory performance will be evaluated using mixing ability test at before prosthesis fabrication and 3 ± 1 months after completion of treatment. Test specimens will be prepared from commercially available chewing gums (pink and blue). Strips of 30 mm in length will be cut from both colors and manually stuck together and the test strips which will be chewed on by the patient for a total of 20 strokes. The number of strokes will be counted by the subject and the experimenter. Instructions will be given to chew on the right or left sides, both, as preferred (habitual chewing), and to terminate in a closed mouth position thereafter open the mouth to enable the experimenter to remove the gum. The degree to which the colors were mixed will be quantified and scored by visual assessment using color and shape rating scales.
  6. Direct expenses shall be calculated by assimilating all expenses incurred from the time of implant surgery till the fabrication of prosthesis for implant treatment exclusively.

Variables to be estimated

Cost in rupees for point gain in quality of life after dental implant-supported overdenture treatment and QALY scores.

Quality of life based on (OHIP-14 Questionnaire), Liverpool Oral Rehabilitation Questionnaire (LORQv3) and Functional outcome using chewing ability test scores.

Analysis of the variables-

Descriptive statistical measures will be used to summarize the data. Categorical data will be expressed in frequency and proportions, normality of continuous data on cost, and quality of life scores will be tested using Shapiro-Wilk test for normality. Normally distributed data will be expressed using mean and standard deviation, and non-normally distributed data will be expressed using median and interquartile range.

The mean and standard of cost in rupees needed for each point gain in the quality of life point after dental implant-supported overdenture treatment in native and free fibular flap reconstructed jaw will be calculated.

The scores on Quality of life (OHIP-14 Questionnaire), Liverpool Oral Rehabilitation Questionnaire (LORQv3) and Functional outcome using chewing ability test scores will be collected before prosthesis fabrication and 3 Â± 1 months after dental implant-supported overdenture treatment and compared using Student’s t-test or Wilcoxon’s Signed Rank test in both the groups based on the compliance or non-compliance to the parametric tests assumptions.

 
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