FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/03/083181 [Registered on: 24/03/2025] Trial Registered Prospectively
Last Modified On: 24/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Comparison of digitally and traditionally made artificial facial parts including eyes/ ears/nose/mid-face. 
Scientific Title of Study   A comparative outcome evaluation of digitally and conventionally fabricated maxillofacial prosthesis: A cross -over randomized control trial. 
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  Associate Professor 
Affiliation  PGIMER, Chandigarh 
Address  Room no 215, Oral Health Sciences Center, Post Graduate Institute of Medical Education and Research, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  08283827291  
Fax    
Email  drbhavitamds@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Bhavita Wadhwa 
Designation  Associate Professor 
Affiliation  PGIMER, Chandigarh 
Address  Room no 215, Oral Health Sciences Center, Post Graduate Institute of Medical Education and Research, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  08283827291  
Fax    
Email  drbhavitamds@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Bhavita Wadhwa 
Designation  Associate Professor 
Affiliation  PGIMER, Chandigarh 
Address  Room no 215, Oral Health Sciences Center, Post Graduate Institute of Medical Education and Research, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  08283827291  
Fax    
Email  drbhavitamds@gmail.com  
 
Source of Monetary or Material Support  
Research Grant Cell, Post Graduate Institute of Medical Education and Research, Chandigarh, India - 160012 
 
Primary Sponsor  
Name  Post Graduate Institution Medical Education and Research Chandigarh 
Address  Post Graduate Institution Medical Education and Research, Chandigarh, India - 160012 
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 Bhavita Wadhwa  Oral Health Sciences Center, Post Graduate Institution Medical Education and Research Chandigarh  Room no 215, Oral Health Sciences Center, Post Graduate Institution Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH 
08283827291

drbhavitamds@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: B465||Mucormycosis, unspecified, (2) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventionally fabricated prosthesis  Prosthesis will be fabricated using conventional workflow of manual impression making using appropriate elastomeric impression material. Wax trial prosthesis will be made by manually sculping the wax followed by mold fabrication using Type-IV dental stone. After appropriate shade matching, silicone will be packed in manually made dental stone mold. 
Intervention  Digitally fabricated prosthesis  Prosthesis fabricated by digital workflow using CT scan data or extra-oral facial scans obtained using facial scanner. Data obtained will be used to design the prosthesis digitally using various softwares like meshmixer, autodesk. Designed prosthesis will then be 3D printed in resin for trial followed by digital mold deigning and prinitng. After appropriate shade matching, silicone will be packed in the 3D printed mold. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Well healed maxillofacial defects (intra oral /extra oral/ combination of both) resulting from the surgical resection of benign and malignant tumours, infectious diseases (Mucormycosis) and trauma. 
 
ExclusionCriteria 
Details  1. Patients who underwent radiotherapy less than 6 months ago.
2. Maxillofacial defects due to recurrent malignancy
3. Patients not consenting for the treatment and follow-up schedule.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Quality of life   Quality of life of the patients will be evaluated 1 month after delivery of digitally/conventionally fabricated prosthesis followed by buffer period of 1 week and then after 1 month of delivery of conventionally/digitally fabricated prosthesis.
 
 
Secondary Outcome  
Outcome  TimePoints 
Patient satisfaction  1 month post-insertion of conventional/digital prosthesis and washout period of 2 weeks 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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)   15/04/2025 
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="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Dimensional accuracy of the final prosthesis made by conventional or digital technique will be assessed in terms of marginal fit, weight of the prosthesis, retention/ stability. For this anatomic landmarks on the normal side of the  patient will be identified according to the standardized definitions e.g  glabella, chin, ear, Endocanthion [En], exocanthion [Ex],palpebral superiors [Ps], and palpebral inferiors [pi] which may be used as reference depending upon the location of defect (eye/ ear/ nose).

For this two facial scan will be done one without the prosthesis and another with the prosthesis using the anatomic landmarks as reference, the two scans will be superimposed to evaluate the marginal fit. The weight and retention and stability of the prosthesis will be assessed clinically.

Maxillofacial prostheses restore oral function, including mastication, and improve esthetics and well-being.  The size of the lesion has an inversely proportional impact on the retention, stability, and consistency of the prosthesis, with larger prostheses being heavier and having less retention. Silicone is typically used to fabricate maxillofacial prostheses and offers the advantages of lightness, favorable physicochemical properties, and biocompatibility. Despite its common use, silicone prostheses require frequent replacement because of the discoloration and degradation caused by environmental factors such as temperature variations and ultraviolet radiation. Maxillofacial prostheses have typically been manufactured using a conventional process of pouring silicone into molds. However, the development of computer-aided design and computer-aided manufacturing (CAD-CAM) systems for maxillofacial rehabilitation has resulted in a radical change in the prosthesis fabrication process. Digital technology allows for the virtual planning, design, and manufacture of prostheses.  Scanners are used to capture accurate digital scans with low data redundancy, high speed, precision, and safety. Moreover, they can overcome the limitations of the conventional impression technique, such as patient discomfort and soft tissue distortion, at an increased speed. The digital workflow starts by scanning the patient’s face to obtain anatomic data. A design software program then processes the scan and produces a 3- dimensional (3D) cast of the prosthesis that is later manufactured. Digital databases have recently been proposed to facilitate the generation of anatomic parts during the design process. Some 3D printers have been developed to allow direct fabrication of silicone prostheses from 3D casts in an additive manufacturing process in which parts are built layer-by-layer. Single droplets of silicone are dosed onto the working surface according to the standard tessellation language (STL) mesh and then polymerized in layers with ultraviolet light. Hence, printable silicone must flow at a constant rate, retain its shape, and have a controllable polymerization rate.The 3D printing of silicones is the last step of a more accurate, more rapid, and less expensive digital approach to fabricate maxillofacial prostheses.

 

 
Close