| 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
|
|
|
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
|
|
|
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. |