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CTRI Number  CTRI/2025/02/080796 [Registered on: 18/02/2025] Trial Registered Prospectively
Last Modified On: 06/05/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative study between cad-cam technology designed (3d printed) versus conventional bite splints in joining of displaced lower jaw fractures  
Scientific Title of Study   Comparative study between cad-cam designed (3d printed ) versus conventional occlusal splints in reduction of displaced mandibular fractures 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Riddhi H Patil 
Designation  Resident 
Affiliation  Krishna Vishwa Vidyapeeth 
Address  Room no 24 2nd floor dept of oral and maxillofacial surgery School of dental sciences KVV Karad

Satara
MAHARASHTRA
415110
India 
Phone  09075527078  
Fax    
Email  patilriddhi942@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nilesh Mishra 
Designation  Head of the department  
Affiliation  Krishna Vishwa Vidyapeeth 
Address  Room no 24 2nd floor dept of oral and maxillofacial surgery School of dental sciences KVV Karad
Room no 24 2nd floor dept of oral and maxillofacial surgery School of dental sciences KVV Karad
Satara
MAHARASHTRA
415110
India 
Phone  9158542384  
Fax    
Email  nileshmishra1934@gmail.com  
 
Details of Contact Person
Public Query  
Name  RIDDHI H PATIL 
Designation  Post Graduate Student 
Affiliation  Krishna Vishwa Vidyapeeth 
Address  Room no 24 2nd floor Dept of oral and maxillofacial surgery School of dental sciences KVV Karad

Satara
MAHARASHTRA
415110
India 
Phone  09075527078  
Fax    
Email  patilriddhi942@gmail.com  
 
Source of Monetary or Material Support  
Krishna Vishwa Vidyapeeth and research institute Malkapur Karad District Satara Maharashtra INDIA 415539 
 
Primary Sponsor  
Name  RIDDHI HEMANT PATIL 
Address  Room no 24, Department of oral and maxillofacial surgery School of dental sciences Malkapur Karad District Satara Maharashtra India 415539 
Type of Sponsor  Private medical college 
 
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 Riddhi Patil  Krishna Vishwa Vidyapeeth   School of Dental Sciences Krishna Vishwa Vidyapeeth Malkapur Karad 415539
Satara
MAHARASHTRA 		 09075527078

patilriddhi942@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Krishna Vishwa Vidyapeeth ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S026||Fracture of mandible,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  cad cam / 3d printed splints   cad cam / 3d printed splints compared with conventional splints 
Intervention  use cad cam splint vs conventional splint in achieving intraop occlusion   sample size is 30 and 15 will be in conventional group and 15 patients in study group Fabrication of conventional splints: An impression of the patients dentition was obtained, and casts were prepared with dental stone. Mock surgery was performed, and occlusion was set to the maximal intercuspation. The interocclusal splint was fabricated with a thickness of 2-3 mm using a cold-cure acrylic material (DPI RR®) by the traditional ‘finger adapted dough’ method. The setting process was chemically mediated, and the time taken for completion of the setting reaction was 7-10 min. The splints were then trimmed to remove undercuts and polished Fabrication of CAD/CAM splints: The patients CT images (0.6 mm slice thickness) in DICOM (Digital Imaging and Communications in Medicine) format were converted into stereolithographic (STL) images using the segmentation software Intraoral scanning of maxillary as well as mandibular dentition was done using the intraoral scanning device and the resultant images were saved as STL files. The converted CT STL images and the intraoral scanning images were integrated to obtain the exact tooth morphology. Virtual surgical planning (VSP) was carried out. Fracture was recreated on the generated STL model. Fractured fragments were virtually reduced to their anatomic configuration, with maximal intercuspation of teeth. A virtual interocclusal splint corresponding to the pre trauma occlusion was constructed with a thickness of 2-3 mm and printed using Photopolymer Clear Resin® (Form labs) in the CAD/CAM 3- dimensional (3D) printer by an additive technique. Sterilization of both the conventional and CAD/CAM splints was carried out by immersion in cidex (2.45 w/v activated glutaraldehyde) for half an hour before the surgery. . Surgical procedure ORIF of all fractures was carried out using a standard surgical protocol, by a single surgeon. Local anesthetic administration was performed at the surgical site. Vestibular or crevicular incision was applied as required by the fracture pattern. Mucoperiosteal flap reflection was carried out to expose and visualize the fractured segments. Reduction of fracture was performed with conventional splints in the control group and CAD/CAM splints in the study group Fixation of the fracture was achieved with miniplates and two screws on both sides of the fracture. Closure of the surgical wound was completed using resorbable sutures  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients aged between 20 and 60 years.
Presence of mandibular fractures with displacement
Presence of post-traumatic malocclusion.

 
 
ExclusionCriteria 
Details  Patients with undisplaced mandibular fractures.
Presence of post-traumatic occlusion.
Any underlying condition such as severe systemic diseases, inability to undergo surgery, previous mandibular surgeries
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Occlusion stability
2. Interfragmentary distance between two displaced fractured segments post reduction to be measured intraoperatively 		 post op day 1
post op day 7
post op day 30 
 
Secondary Outcome  
Outcome  TimePoints 
surgeon comfort while using the splint
patient comfort & post op occlusion  		 post op occlusion to be assessed at 1st day post op
7 days post op
30 days post op  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   05/03/2025 
Date of Study Completion (India) 01/03/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 01/03/2026 
Estimated Duration of Trial   Years="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [patilriddhi942@gmail.com].

  6. For how long will this data be available start date provided 24-01-2025 and end date provided 24-03-2026?
    Response (Others) -  No tentative dates

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		 This study is to make easy about operating mandibular fractures with derranged occlusion. This study aims to assess the efficacy and functionality of CAD-CAM splints in achieving precise anatomic reduction of mandibular fractures and restoring ideal pre trauma occlusion, in comparison with conventional handmade splints. 
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