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CTRI Number  CTRI/2023/06/054553 [Registered on: 30/06/2023] Trial Registered Prospectively
Last Modified On: 29/06/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   3D printed space maintainer (3D-SM) vs. traditional band and loop space maintainer (C-BLSM) 
Scientific Title of Study   Effectiveness of 3D printed space maintainer Vs traditional Bond and loop space maintainer following loss of primary teeth. A randomized clinical trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anuj Bhardwaj 
Designation  Professor and Head 
Affiliation  College of Dental Sciences and Hospital 
Address  Department of Conservative Dentistry, 301, 1st Floor, Jhoomar Ghat AB Rd near Hotel Mashal Rau Madhya Pradesh

Indore
MADHYA PRADESH
453331
India 
Phone    
Fax    
Email  dranuj_84@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Anuj Bhardwaj 
Designation  Professor and Head 
Affiliation  College of Dental Sciences and Hospital 
Address  Department of Conservative Dentistry, 301, 1st Floor, Jhoomar Ghat AB Rd near Hotel Mashal Rau Madhya Pradesh

Indore
MADHYA PRADESH
453331
India 
Phone    
Fax    
Email  dranuj_84@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Anuj Bhardwaj 
Designation  Professor and Head 
Affiliation  College of Dental Sciences and Hospital 
Address  Department of Conservative Dentistry, 301, 1st Floor, Jhoomar Ghat AB Rd near Hotel Mashal Rau Madhya Pradesh

Indore
MADHYA PRADESH
453331
India 
Phone    
Fax    
Email  dranuj_84@yahoo.co.in  
 
Source of Monetary or Material Support  
College of Dental Sciences and Hospital Rau Indore 
 
Primary Sponsor  
Name  Dr Anuj Bhardwaj 
Address  College Of Dental Science and Hospital F12 Jhoomar Ghat AB Rd near Hotel Mashal Rau Madhya Pradesh 453331 
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 Anuj Bhardwaj  College Of Dental Science and Hospital  301, third floor, Department of Conservative Dentistry and Endodontics, F12 Jhoomar Ghat AB Rd near Hotel Mashal Rau Madhya Pradesh 453331
Indore
MADHYA PRADESH 		 7898540222

dranuj_84@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of College Of Dental Science & Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K006||Disturbances in tooth eruption,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  3D Printed Space Maintainer  The 3D printed space maintainer (3D-SM) is a novel device that can be custom-designed and fabricated in a single visit. The placement will be done and will be evaluated till the eruption of the permanent tooth (6-12 months). 
Comparator Agent  Conventional Band and loop space maintainer  The most used SMs are the conventional band and loop space maintainers (C-BLSM), which are fabricated in a dental laboratory and require multiple visits for placement. The placement will be done and will be evaluated till the eruption of the permanent tooth (6-12 months). 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  Inclusion Criteria
Clinical criteria
Systemically healthy children.
Grossly mutilated single molars on either side, requiring
extraction.
Freshly extracted single molars bilaterally in the same arch
or opposite arch.
Sound and healthy teeth adjacent to the extraction site.
No abnormal dental conditions such as crossbite, open bite,
and deep bite.
Radiographic criteria
Presence of succedaneous tooth bud.
Presence of at least 1 mm bone overlying the succedaneous
tooth germ with less than one-third of the root formed. 
 
ExclusionCriteria 
Details  Grossly carious teeth were adjacent to the created space.
Absence of teeth on the mesial or distal side of the teeth to be
extracted. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Survival Time of Space maintainers compared
Gingival Health of the Abutment Tooth
 		 follow up intervals 0 1 3 6 and 9 months 
 
Secondary Outcome  
Outcome  TimePoints 
Patient Satisfaction  follow up intervals 0 1 3 6 and 9 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 2 
Date of First Enrollment (India)   07/07/2023 
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="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The premature loss of primary teeth can lead to several dental problems, including space loss, malocclusion, and impacted permanent teeth. Space maintainers (SMs) are dental devices used to preserve space and prevent these problems from occurring. The most used SMs are the conventional band and loop space maintainers (C-BLSM), which are fabricated in a dental laboratory and require multiple visits for placement. 

Recent advancements in technology have led to the development of 3D printing in dentistry, which has the potential to revolutionize the fabrication of SMs. The 3D printed space maintainer (3D-SM) is a novel device that can be custom-designed and fabricated in a single visit. However, there is limited research on the effectiveness of 3D-SMs compared to traditional C-BLSMs. 

Therefore, this randomized clinical trial aims to compare the effectiveness of 3D-SMs and C-BLSMs in preserving space and preventing dental problems following the loss of primary teeth. The trial will assess the survival rate, clinical performance, and patient satisfaction of both types of SMs. The study will also evaluate the time and cost required for the fabrication and placement of each type of SM. The findings of this study will provide valuable insights into the effectiveness of 3D-SMs compared to traditional C-BLSMs and their potential for use in clinical practice. This research will also contribute to the growing body of literature on the application of 3D printing technology in dentistry and its potential to improve patient outcomes.

 
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