FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/06/088601 [Registered on: 11/06/2025] Trial Registered Prospectively
Last Modified On: 09/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative Evaluation of Different Dental Space Maintainers in Children: A Study of Four Interventions (Conventional, Prefabricated, 3D-Printed, and CAD/CAM) in Pediatric Participants" 
Scientific Title of Study   Comparison and evaluation of effectiveness and clinical performance of conventional space maintainer, preformed space maintainer , 3-D printed space maintainer and CAD/CAM space maintainer  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SHRIYA 
Designation  JUNIOR RESIDENT 1 
Affiliation  Santosh Deemed to be University 
Address  Department of Pediatric and Preventive Dentistry , Santosh Dental College ,Santosh Deemed to be University k-BLOCK ,HOUSE NO.K-64, SECTOR -12 PRATAP VIHAR , GHAZIABAD UTTAR PRADESH 201009 India

Ghaziabad
UTTAR PRADESH
201009
India 
Phone  6386833522  
Fax    
Email  shrivastavashriya56@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Natasha Gambhir 
Designation  Professor and Assistant Dean 
Affiliation  Santosh Deemed to be University 
Address  Department of Pediatric and Preventive Dentistry , Santosh Dental College ,Santosh Deemed to be University k-BLOCK ,HOUSE NO.K-64, SECTOR -12 PRATAP VIHAR , GHAZIABAD UTTAR PRADESH 201009 India

Ghaziabad
UTTAR PRADESH
201009
India 
Phone  9871966965  
Fax    
Email  tash_aa@yahoo.com  
 
Details of Contact Person
Public Query  
Name  SHRIYA 
Designation  JUNIOR RESIDENT 1 
Affiliation  Santosh Deemed to be University 
Address  Department of Pediatric and Preventive Dentistry , Santosh Dental College ,Santosh Deemed to be University k-BLOCK ,HOUSE NO.K-64, SECTOR -12 PRATAP VIHAR , GHAZIABAD UTTAR PRADESH 201009 India

Ghaziabad
UTTAR PRADESH
201009
India 
Phone  6386833522  
Fax    
Email  shrivastavashriya56@gmail.com  
 
Source of Monetary or Material Support  
Department of Pediatric and Preventive Dentistry , Santosh Dental College ,Santosh Deemed to be University k-BLOCK ,HOUSE NO.K-64, SECTOR -12 PRATAP VIHAR , GHAZIABAD UTTAR PRADESH 201009 India  
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 SHRIYA  Santosh deemed to be university  Department of Pediatric and Preventive Dentistry , Santosh Dental College ,Santosh Deemed to be University k-BLOCK ,HOUSE NO.K-64, SECTOR -12 PRATAP VIHAR , GHAZIABAD UTTAR PRADESH 201009 India
Ghaziabad
UTTAR PRADESH 		 06386833522

shrivastavashriya56@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL HUMAN EHTICS COMMITTEE, santosh Deemded to be University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Children with premature loss of primary molars requiring space maintenance to prevent malocclusion, crowding, or improper eruption of permanent teeth would be included 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Space Maintainer Preformed Space Maintainer   Conventional space maintainer – custom-made using traditional space maintainer Preformed space maintainers – ready-made appliances  
Intervention  Digital space maintainer  3D Printed Space Maintainer CAD/CAM Space Maintainer are digital space maintainer  
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  1.Grossly decayed single molars on either side/single side indicated for extraction.
2.Sound and healthy teeth adjacent to the extraction site
3.Presence of succedaneous tooth bud
4.No abnormal dental conditions such as crossbite, open bite, and deep bite
5.Presence of at least 1 mm bone overlying the succedaneous tooth germ with less than one-
third of the root formed.
6.Parents who gave consent
 
 
ExclusionCriteria 
Details  1.Grossly carious tooth adjacent to the extraction site
2.Children whose parents refused to give consent
3.Presence of any systemic disease
4.Absence of teeth on the mesial or distal side of the teeth to be extracted
5.In cases of Space Loss
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
evaluate and compare the clinical effectiveness and survival rate of conventional, preformed, 3D-printed, and CAD/CAM space maintainers in pediatric patients over a 12-month follow-up period. This includes assessment of the appliance’s retention, stability, structural integrity, and ability to maintain the space for the eruption of permanent teeth  Follow up at baseline, 1 month, 6 months, and 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Patient Comfort: Assessed via Likert Scale for patient/parent satisfaction with comfort levels for Conventional, Preformed, 3D Printed, and CAD/CAM space maintainers.
Material Durability: Evaluated for structural integrity (e.g., solder breakage, loop breakage, de-cementation) at 1, 6, and 12 months.
Gingival Health of Abutment Tooth: Measured using the Loe and Silness Gingival Index (1963) to assess normal, mild, or moderate inflammation at follow-up intervals. 		 1 month
6 months
12 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   07/07/2025 
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="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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

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

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

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [shrivastavashriya56@gmail.com].

  6. For how long will this data be available start date provided 27-05-2025 and end date provided 27-05-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This clinical study is designed to assess and compare the performance of four different types of space maintainers used in pediatric dentistry – conventional, preformed, 3D printed, and CAD CAM fabricated. The trial will involve 60 children between the ages of 4 and 8 who require space maintenance due to early loss of primary molars. Participants will be randomly divided into four groups, each receiving one type of appliance. The devices will be monitored and evaluated at intervals of 1, 6, and 12 months to measure their effectiveness, durability, impact on gum health, and overall satisfaction from both children and their parents. The goal of the study is to determine which type of space maintainer provides the most reliable results and improved patient experience for long-term dental development.

 
Close