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CTRI Number  CTRI/2025/07/091332 [Registered on: 21/07/2025] Trial Registered Prospectively
Last Modified On: 21/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   A Study on How Two Types of Dental Devices Affect Gum Healing and Cleanliness in Children Who Have Lost Baby Teeth 
Scientific Title of Study   Comparative Evaluation of the Effect of Pre-Fabricated and Conventional Band and Loop Space Maintainer on Post-Extraction Wound Healing and Assessment of Plaque Accumulation and Gingival Health of the Abutment Tooth: A Split Mouth Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kalyani Barve 
Designation  Postgraduate Student 
Affiliation  Government Dental College and Hospital, Mumbai 
Address  Government Dental College and Hospital Mumbai, Department number 36, Fort, Near CST Mumbai

Mumbai
MAHARASHTRA
400001
India 
Phone  7387735987  
Fax    
Email  kalyanibarve277@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dimple Padawe 
Designation  Professor and Head 
Affiliation  Department of Pediatric and Preventive Dentistry, Government Dental College and Hospital, Mumbai 
Address  Department of Pediatric and Preventive Dentistry, Government Dental College and Hospital Mumbai, Near CSMT, Fort, Mumbai

Mumbai
MAHARASHTRA
400001
India 
Phone    
Fax    
Email  dimplepadawe@gmail.com  
 
Details of Contact Person
Public Query  
Name  Kalyani Barve 
Designation  Postgraduate Student 
Affiliation  Government Dental College and Hospital, Mumbai 
Address  Government Dental College and Hospital Mumbai, Department of Pediatric and Preventive Dentistry, Fort, Near CST Mumbai

Mumbai
MAHARASHTRA
400001
India 
Phone  7387735987  
Fax    
Email  kalyanibarve277@gmail.com  
 
Source of Monetary or Material Support  
Personal funds 
 
Primary Sponsor  
Name  Kalyani Barve 
Address  GDCH Mumbai Girls Hostel, Fort, Mumbai 
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 Kalyani Barve  Government Dental College and Hospital Mumbai  Department of Pediatric and Preventive Dentistry, Department number 36, GDCH Mumbai, P D Mello Road, Near CSMT, Fort, Mumbai
Mumbai
MAHARASHTRA 		 7387735987

kalyanibarve277@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government Dental College and Hospital Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K081||Complete loss of teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Band and Loop Space maintainer  The conventional band-and-loop space maintainer is a fixed dental appliance used to preserve space after premature loss of a primary molar. It consists of a stainless steel band cemented around an adjacent tooth and a loop extending to maintain the space for the unerupted permanent tooth. This appliance is simple, effective, and widely used in pediatric dentistry to prevent mesial drift of posterior teeth.  
Intervention  Pre-fabricated band and loop space maintainer  Prefabricated space maintainers are commonly used in pediatric dentistry to prevent space loss after premature primary tooth loss. They are made of stainless steel. These appliances help guide proper eruption of permanent teeth, preventing crowding or misalignment. Prefabricated designs allow for quicker placement and cost-effectiveness compared to custom-made maintainers, making them a practical choice in many clinical cases. 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  Bilateral primary mandibular first molars indicated for extraction, Presence of a succedaneous tooth bud confirmed radiographically, Healthy abutment tooth, Adequate bone coverage that indicates more than 6 months remained until permanent tooth eruption
 
 
ExclusionCriteria 
Details  Succedaneous tooth with more than 1/3rd of root already calcified, Space left by prematurely lost teeth is greater than space needed for the permanent successor, Succedaneous tooth is absent, Medically compromised children and children with special health care needs.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Wound Healing  Day 3 and Day 7 
 
Secondary Outcome  
Outcome  TimePoints 
Plaque accumulation & Gingival health status  Baseline, 1 month, 2 months, 3 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   N/A 
Date of First Enrollment (India)   01/08/2025 
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 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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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 [kalyanibarve277@gmail.com].

  6. For how long will this data be available start date provided 13-02-2025 and end date provided 15-10-2025?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Conventional band and loop space maintainers are widely used for space maintenance but have drawbacks such as soldering failures and multiple appointments. Prefabricated space maintainers address this by requiring less time and only one appointment. However, space maintainers may affect post-extraction wound healing and plaque accumulation, leading to gingivitis. Objective: This study aims to compare the effects of prefabricated and conventional band and loop space maintainers on post-extraction wound healing, plaque accumulation, and gingival health of the abutment tooth. Methodology: Split mouth study will include 10 healthy children aged five to eight years with bilateral mandibular primary first molars indicated for extraction. Each patient’s experimental side will be randomly selected, dividing quadrants into two groups: Conventional and Prefabricated Band and Loop space maintainers. Follow-up appointments will be scheduled on 3rd and 7th day post-extraction to assess wound healing using Landry index, and at 1st, 2nd, and 3rd months to assess plaque using Plaque index and gingival health of abutment using Gingival index.  
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