FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/08/093713 [Registered on: 26/08/2025] Trial Registered Prospectively
Last Modified On: 21/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of different types of Band and loop space maintainers 
Scientific Title of Study   Comparative evaluation of the clinical success and periodontal effect of Conventional band and loop, Prefabricated E- space maintainers and Fiber reinforced composite resin space maintainers: A RANDOMIZED CONTROLLED CLINICAL TRIAL 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Iccha Upadhyay 
Designation  Postgraduate 
Affiliation  SRM Ramapuram  
Address  Department Pediatric and preventive Dentistry,Dental,room no.8,SRM Dental College Bharathi Salai, Ramapuram, Chennai – 600 089. Tamil Nadu, India.

Chennai
TAMIL NADU
600089
India 
Phone  8277795407  
Fax    
Email  iu9977@srmist.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr. Shankar.P 
Designation  Reader 
Affiliation  SRM Ramapuram  
Address  Department of pediatric and preventive dentistry,dental,room no.8,SRM Dental College Bharathi Salai, Ramapuram, Chennai – 600 089. Tamil Nadu, India.

Chennai
TAMIL NADU
600089
India 
Phone  9884585808  
Fax    
Email  shankarp1@srmist.edu.in  
 
Details of Contact Person
Public Query  
Name  Iccha Upadhyay 
Designation  Postgraduate 
Affiliation  SRM Ramapuram  
Address  Department of pediatric and preventive dentistry,dental,room no.8,SRM Dental College Bharathi Salai, Ramapuram, Chennai – 600 089. Tamil Nadu, India.

Chennai
TAMIL NADU
600089
India 
Phone  8277795407  
Fax    
Email  iu9977@srmist.edu.in  
 
Source of Monetary or Material Support  
SRM RAMAPURAM SRM Dental College Bharathi Salai, Ramapuram, Chennai – 600 089. Tamil Nadu, India. 
 
Primary Sponsor  
Name  DrIccha Upadhyay 
Address  Department of pediatric and preventive dentistry, dental,room no.8,SRM Dental College Bharathi Salai, Ramapuram, Chennai – 600 089. Tamil Nadu, India. 
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 
Iccha Upadhyay  SRM Dental College  Department of pediatric and preventive dentistry,dental,room no.8
Chennai
TAMIL NADU 		 8277795407

iu9977@srmist.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IRB, SRM Dental College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Extracted primary 1st molar with adequate width and space for permanent premolar and children between age of 4-8 years  
Patients  (1) ICD-10 Condition: K00||Disorders of tooth development anderuption,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Comparing band and loop space maintainers  Comparing preformed-e-space maintainer, fiber reinforced space maintainer with conventional band and loop space maintainer 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  1.Children between the age group of 4-8 years with Frankels behaviour rating score of 1 and 2
2.Systemically healthy children.
3.Children with missing maxillary or mandibular primary molars
4.Sound and healthy teeth adjacent to the missing tooth.
5.No abnormal dental conditions such as crossbite, open bite, and deep bite.
6.Presence of succedaneous tooth bud.
7.Presence of at least 1 mm bone overlying the succedaneous tooth germ with less than one-third of the root formed
 
 
ExclusionCriteria 
Details  1) Children with special health care needs.
2) Children with underlying any systemic conditions.
3) Children who are allergic to local anaesthesia or any of the materials used in the study.
4) Grossly carious teeth adjacent to the missing tooth
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Clinical success and periodontal health of band and loop space maintainers  1,3 and 6 month  
 
Secondary Outcome  
Outcome  TimePoints 
To assess and compare the clinical success of Conventional band and loop space maintainers, Prefabricated E- space maintainers and Fiber reinforced band–loop space maintainers at 1,3 and 6 months
 		 To assess and compare the periodontal health of Conventional band and loop space maintainers, Prefabricated E- space maintainers and Fiber reinforced band–loop space maintainers at 1,3 and 6 month 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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)   13/09/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - NO
Brief Summary  

This study is a randomized controlled clinical trial comparing the clinical success and periodontal effects of three types of space maintainers in children aged 4–8 years:

  1. Conventional band and loop space maintainers

  2. Prefabricated E-band and loop space maintainers

  3. Fiber-reinforced composite resin (FRCR) space maintainers

A total of 45  children meeting strict inclusion criteria will be randomly assigned to one of the three groups (15 per group). Each child will receive the allocated appliance after extraction of a primary molar. The plaque index (PI) and gingival index (GI) will be recorded for the banded tooth at 1, 3, and 6 months to evaluate periodontal health, and appliance failures (cement loss, deformation, debonding, etc.) will be documented to assess clinical success.

The study aims to determine whether prefabricated E-band and loop or FRCR space maintainers perform better than conventional designs in terms of survival rate, periodontal health, and patient comfort, based on existing literature suggesting potential advantages like reduced chair time, better aesthetics, and less risk to abutment teeth. Data will be analyzed using Chi-square, repeated measures ANOVA, and independent t-tests.

In essence, the trial seeks evidence to guide pediatric dentists toward the most effective, patient-friendly, and periodontally safe space maintainer option for managing premature primary molar loss.

 
Close