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CTRI Number  CTRI/2024/03/063962 [Registered on: 11/03/2024] Trial Registered Prospectively
Last Modified On: 04/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry
Process of Care Changes
Other (Specify) [Oral Health related Quality of Life]  
Study Design  Randomized, Crossover Trial 
Public Title of Study   A trial to evaluate the effect of obturator on oral health related quality of life made using traditional and digital technique. 
Scientific Title of Study   A cross-over randomized control trial to evaluate the influence of obturator on oral health related quality of life made using conventional and digital method. 
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 Bhavita Wadhwa 
Designation  Assistant Professor 
Affiliation  Post Graduate Institute of Medical Education and Research Chandigarh 
Address  Room No.107, Oral Health Science Center, PGIMER Sector 12
Room No.107, Oral Health Science Center, PGIMER, Chandigarh Sector 12
Chandigarh
CHANDIGARH
160012
India 
Phone  8283827291  
Fax    
Email  drbhavitamds@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bhavita Wadhwa 
Designation  Assistant Professor 
Affiliation  Post Graduate Institute of Medical Education and Research Chandigarh 
Address  Room No.107, Oral Health Science Center, PGIMER Sector 12
Room No.107, Oral Health Science Center, PGIMER, Chandigarh Sector 12
Chandigarh
CHANDIGARH
160012
India 
Phone  8283827291  
Fax    
Email  drbhavitamds@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Bhavita wadhwa 
Designation  Assistant Professor 
Affiliation  Post Graduate Institute of Medical Education and Research Chandigarh 
Address  Room No.215, Oral Health Science Center, PGIMER Sector 12, 160012,Chandigarh
Room No.215, Oral Health Science Center, PGIMER Sector 12, 160012
Chandigarh
CHANDIGARH
160012
India 
Phone  8283827291  
Fax    
Email  drbhavitamds@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research, Ansari Nagar, New Delhi 29 
 
Primary Sponsor  
Name  Dr Bhavita Wadhwa 
Address  Room No- 107, Oral Health Science Center, PGIMER Chandigarh 
Type of Sponsor  Other [Self] 
 
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 Bhavita Wadhwa  Post Graduate Institute of Medical Education and Research Chandigarh  Room No.107,Unit of Prosthodontics, Oral Health Science Center, PGIMER, 160012 Sector 12
Chandigarh
CHANDIGARH 		 8282827291

drbhavitamds@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Postgraduate Institute of Medical Education and Research, Chandigarh, Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C058||Malignant neoplasm of overlappingsites of palate, (2) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventionally fabricated obturator  after 2 weeks of wash out period, the conventionlly fabricated obturator will be given for one month and we will record patient satisfaction and quality of life. 
Intervention  Digitally Fabricated Obturator  This digitally fabricated obturator is given for 1 months followed by 2 weeks wash out period with the interm obturator. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Inclusion criteria:
1. Patients both males and females with age range of 18-80 years old.
2. Well healed maxillary defects resulting from the surgical resection of benign and malignant tumours of maxilla, infectious diseases, osteomyelitis, and trauma.
3. Patients with untreated cleft palate.
4. Patients who provide informed consent for the study
 
 
ExclusionCriteria 
Details  Exclusion criteria:
1. Maxillary defects due to recurrent malignancy
2. Completely edentulous patients
3. Patients with bilateral maxillectomy
4. Syndromic patients
5. Patients who underwent radiotherapy less than 6 months ago.
6. Pregnant patients at the time of recruitment
7. Patients not consenting for the treatment and follow-up schedule
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Oral health related quality of life using OHIP 14  Baseline, 4 weeks, 8 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Patient satisfaction   first in 4 weeks followed by 2 weeks wash out period followed by follow up in 4 weeks 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   01/04/2024 
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="3"
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  

A thorough medical history will be taken at the time of recruitment. OHIP-14 questionnaire and VAS score using obturator functioning scale for their level of difficulty with various oral functions will be filled at the time of recruitment (without Prosthesis), one month after the delivery of definitive prosthesis and one month after change of their prosthesis made with an alternate method than the previous one.

 

Conventional Pathway:

After blocking the undercuts within the maxillary defect, a preliminary impression will be made in irreversible hydrocolloid. The plaster cast obtained will be utilised for the fabrication of the custom tray for the final impression. After the application of the compatible adhesive, an additional silicone impression will be made for the defect, residual maxilla, and teeth. The impression will be sent for the fabrication of the cast partial denture framework. Following the intra oral evaluation of its fit, jaw relation, teeth setting and final processing in heat cure polymethyl methacrylate denture base resin will be done. At the time of final prosthesis delivery, evaluation of the intra-oral fit, occlusion, and comfort will be assessed. Post- delivery instruction and review after one day, and 1 month will be done for the patient.

 

Digital Pathway:

CBCT will be done after recruitment of the patient. The dicom data will be converted to .stl using Mimics software. A virtual, perforated titanium framework will be designed on the computer and a 3-D printed framework will be obtained. After its intra-oral evaluation for fit and accuracy, jaw relation, teeth set up, and processing in will be done on the 3 D printed model. Evaluation of the intra oral fit, occlusion, and comfort will be done at the time of prosthesis delivery. Post-delivery instruction and review after one day, and 1 month will be reinforced.

The subjects will be asked to score their overall satisfaction and denture-related parameters 3 months after delivery of each denture. Additionally, they will be asked to choose their preferred denture type at the end of the trial.

Two obturators will be made for each patient; one made by conventional method and other by digital method. A minimum of two hundred units of maxillary prosthesis will be made for the recruited patients. High strength denture base resin will be used as a denture base and cross-linked teeth will be used for the patients.

 
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