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CTRI Number  CTRI/2020/11/029271 [Registered on: 20/11/2020] Trial Registered Prospectively
Last Modified On: 13/11/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative evaluation of the survival rate and gingival health of 3D printed band and loop space maintainer with conventional band and loop space maintainer in children  
Scientific Title of Study   Comparative evaluation of the survival rate and gingival health of 3D printed vs. conventional band and loop space maintainers in children  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  G L G S PRUDHVI KUMAR 
Designation  Post Graduate Student 
Affiliation  GSL Dental College and Hospital 
Address  Room no 8 Department of Pediatric and Preventive Dentistry GSL Dental College and Hospital NH 16 Jagannadhapuram Agraharam Lakshmipuram Rajahamundry

East Godavari
ANDHRA PRADESH
533296
India 
Phone  9398850377  
Fax    
Email  prudhvi.gannamani@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Veena Arali 
Designation  Professor and HOD 
Affiliation  GSL Dental College and Hospital 
Address  Room no - 8 Department of Pediatric and Preventive Dentistry GSL Dental College and Hospital NH - 16 Jagannadhapuram Agraharam Lakshmipuram Rajahamundry

East Godavari
ANDHRA PRADESH
533296
India 
Phone  7760748787  
Fax    
Email  gslpedo@gmail.com  
 
Details of Contact Person
Public Query
 
Name  G L G S PRUDHVI KUMAR 
Designation  Post Graduate Student 
Affiliation  GSL Dental College and Hospital 
Address  Room no 8 Department of Pediatric and Preventive Dentistry GSL Dental College and Hospital NH 16 Jagannadhapuram Agraharam Lakshmipuram Rajahamundry

East Godavari
ANDHRA PRADESH
533296
India 
Phone  9398850377  
Fax    
Email  prudhvi.gannamani@gmail.com  
 
Source of Monetary or Material Support  
Department of Pediatric and Preventive Dentistry GSL Dental College and Hospital Rajahmundry 
 
Primary Sponsor  
Name  nil 
Address  nil 
Type of Sponsor  Other [nil] 
 
Details of Secondary Sponsor  
Name  Address 
nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
G L G S PRUDHVI KUMAR  Department of Pediatric and Preventive Dentistry  room no 8 Department of Pediatric and Preventive Dentistry GSL Dental College and Hospital NH 16 Jagannadhapuram Agraharam Lakshmipuram Rajahamundry
East Godavari
ANDHRA PRADESH 
9398850377

prudhvi.gannamani@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  
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 band and loop Space Maintainer  3D printed metal band and loop space maintainer easy to fabricate less time consuming more efficient no need for impressions good patient cooperation easily acceptable by children  
Comparator Agent  conventional band and loop space maintainer  conventional space maintainer is cost effective traditionally followed high success rate  
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  Patients in the age group of 4 to 9 years.
Extraction sites or teeth indicated for extraction with no space loss.
Erupting permanent teeth having adequate bone covering.
Fully erupted carious free teeth, will be included in the study.
 
 
ExclusionCriteria 
Details  Patients not in the age group of 4 to 9 years.
teeth not indicated for extraction.
extraction sites with space loss.
permanent teeth having non adequate bone covering.
partially erupted carious teeth 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
3D printed band and loop space maintainer will have a better survival rate and gingival health compared to conventional band and loop space maintainer in children

 
9 months 
 
Secondary Outcome  
Outcome  TimePoints 
There is no significant difference between survival rate and gingival health of 3D printed vs. conventional band and loop space maintainers in children   9 months 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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 1 
Date of First Enrollment (India)   01/12/2020 
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="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  


The present in vivo study aimed to compare 3D printed vs. conventional band and loop Space Maintainers(SM) and evaluate their survival rate and gingival health in children and to obtain results for which is the best Space maintainer in terms of survival rate and gingival health by including 20 patients of age 4 to 9 years with 20 extraction sites will be selected after obtaining written informed consent from the parents of the child. And the two types of BAND &LOOP SM will be fabricated and will be divided into two groups Group I(n=10) - CONVENTIONAL BAND &LOOP SM, Group II(n=10)  – 3D BAND &LOOP SM. A brief history will be recorded, and clinical examination will be done, Intraoral periapical radiographs will be taken in areas of tooth loss, Study models will be prepared, and space analysis will be carried out for every child, For every selected child, oral prophylaxis will be done before placement of a space maintainer and a conventional band and loop will be fabricated according to the technique described by Finn, and for 3D printed space maintainer edentulous space will be scanned using a 3D digital dental scanner followed by the designing of the band and loop similar to the conventional SM, on computer and fabrication will be done using a 3D printer with the material ABS. Both the types of space maintainers will be luted to the teeth in both the groups using type I  Glass Ionomer Cement. Instructions for oral hygiene and appliance maintenance will be given to children and their parents. Patients will be recalled at 3rd and 6th months for evaluation of space maintainers using the criteria for assessing survival rate and gingival health. The results obtained from the criteria mentioned above will be tabulated accordingly and evaluated for statistical significance. The data collected at the 3rd and 6th months will be subjected to statistical analysis.




 
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