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CTRI Number  CTRI/2023/10/058547 [Registered on: 12/10/2023] Trial Registered Prospectively
Last Modified On: 15/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   comparison between 3D printed space maintainer and prefabricated stainless steel space maintainer 
Scientific Title of Study   Comparative evaluation of clinical performance of 3D printed space maintainer using PEEK polymer with that of prefabricated stainless steel space maintainer-An In-vivo study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  JAHANA SHERIN IM 
Designation  postgraduate student 
Affiliation  YENEPOYA DENTAL COLLEGE 
Address  DERALAKATTE MANGALORE KARNATAKA 575018

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9447131656  
Fax    
Email  jahanasherinim656@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  JAHANA SHERIN IM 
Designation  PG STUDENT 
Affiliation  YENEPOYA DENTAL COLLEGE 
Address  DERALAKATT MANGALORE KARNATAKA 575018

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9447131656  
Fax    
Email  jahanasherinim656@gmail.com  
 
Details of Contact Person
Public Query
 
Name  JAHANA SHERIN IM 
Designation  PG STUDENT 
Affiliation  YENEPOYA DENTAL COLLEGE 
Address  DERALAKATT MANGALORE KARNATAKA 575018

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9447131656  
Fax    
Email  jahanasherinim656@gmail.com  
 
Source of Monetary or Material Support  
YENEPOYA INCUBATION CENTRE,YENEPOYA DENTAL COLLEGE 
 
Primary Sponsor  
Name  JAHANA SHERIN IM 
Address  DEPT. OF PEDIATRIC AND PREVENTIVE DENTISTRY, YENEPOYA DENTAL COLLEGE, DERLAKATTE, MANGALORE, KARNATAKA, 575018 
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 AJAY RAO HT  YENEPOYA DENTAL COLLEGE MANGALORE  Department of Pediatric and Preventive Dentistry, Yenepoya Dental College, DERALAKATTE Mangalore KARNATAKA
Dakshina Kannada
KARNATAKA 
9845085048

drajayrao@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
YENEPOYA ETHICS COMMITTEE 2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K084||Partial loss of teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  SPACE MAINTAINER  FABRICATION OF SPACE MAINTAINER, TO MAINTAIN THE SPACE CREATED BY LOSS OF PRIMARY TEETH UNTIL THE ERUPTION OF PERMANENT TEETH Duration-until the eruption of permanent teeth frequency-The appliance is provided only once,in case of any damage appliance will be replaced. follow up check up will be done once in 6 months 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  Children of age group 6-9 years with two posterior edentulous spaces due to premature loss of deciduous molars and indicated for space maintainer 
 
ExclusionCriteria 
Details  Medically compromised patients
Patients with high caries index
Children with dental abnormalities (cross bite/open bite/deep bite)
Children with loss of space 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
CLINICAL SUCCESS RATE OF 3D PRINTED SPACE MAINTAINER AND PREFABRICATED SPACE MAINTAINER IN PEDIATRIC DENTISTRY INTERMS OF PLAQUE INDEX, GINGIVAL INDEX, RETENTION AND SURVIVAL TIME   6 months 
 
Secondary Outcome  
Outcome  TimePoints 
CLINICAL SUCCESS RATE OF 3D PRINTED SPACE MAINTAINER AND PREFABRICATED SPACE MAINTAINER IN PEDIATRIC DENTISTRY INTERMS OF PATIENTS SATISFACTION USING VISUAL ANALOGUE SCALE  end of 6 months 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   20/10/2023 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
review and case report publication in malabar dentist-IDA journal malabar branch,kerala-2025-jan-march edition 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  
The study’s aim is to compare and evaluate the clinical performance of 3D printed space maintainer using PEEK polymer with that of prefabricated stainless steel space maintainer. The result of the study will give additional information regarding the potential use of PEEK polymer material in fabrication of space maintainer.
It is an in-vivo experimental study with 15 children of age group 6-9 years reporting to dept. of pediatric and preventive dentistry, Yenepoya Dental College, who has two posterior edentulous spaces and indicated for space maintainers.
The study will be commenced only after approval from the institutional ethical committee. Once inclusion and exclusion criteria are satisfied consent from parents and child will be obtained prior to the study.
Impressions of upper and lower arch will be made using rubber-based impression material and then Casts will be poured. The cast will be sent to 3D lab at Yenepoya Incubation Centre for the fabrication of 3D space. And then the appliance will be sterilized according to standard sterilization protocol. Prefabricated space maintainer will be adapted on one edentulous space according to user instructions and 3D designed space maintainer using PEEK will be fixed on the other edentulous space. Both the space maintainers will be luted by using resin modified GIC.
All the procedure will be carried out by single operator. At the end of 6 months, patient will be recalled and parameters like plaque index, gingival index, survival time, patient satisfaction will be evaluated and documented. The above results will be subjected to statistical analysis.
 
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