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CTRI Number  CTRI/2024/02/062845 [Registered on: 19/02/2024] Trial Registered Prospectively
Last Modified On: 18/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   This is a study comparing the efficiency of two different oral appliance that is used to preserve the space for the erupting permanent teeth 
Scientific Title of Study   Comparative evaluation of clinical success of conventional space maintainer versus prefabricated space maintainer in children aged 4 to 9 years - A split-mouth randomized controlled 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  Ayesha Fathima 
Designation  Post graduate student 
Affiliation  Saveetha Dental College 
Address  B105, Radiance Royalae, Seneerkuppam, Chennai.
Department of Pediatric and Preventive Dentistry, 5th floor, Saveetha Dental College, Seneerkuppam, Chennai
Chennai
TAMIL NADU
600056
India 
Phone  8344471133  
Fax    
Email  152111004.sdc@saveetha.com  
 
Details of Contact Person
Scientific Query  
Name  Mahesh Ramakrishnan 
Designation  Professor  
Affiliation  Saveetha Dental College 
Address  Saveetha Dental college, Seneerkuppam, Chennai .

Chennai
TAMIL NADU
600056
India 
Phone  9840322728  
Fax    
Email  maheshpedo@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ayesha Fathima 
Designation  Post graduate student 
Affiliation  Saveetha Dental College 
Address  B105, B Block,72/1, Poonamallee High Rd, opp. Saveetha Dental College, Senneer Kuppam, Chennai, Tamil Nadu
Department of Pediatric and Preventive Dentistry,Saveetha Dental College, Seneerkuppam, Chennai
Chennai
TAMIL NADU
600056
India 
Phone  8344471133  
Fax    
Email  152111004.sdc@saveetha.com  
 
Source of Monetary or Material Support  
Saveetha Dental college and Hospitals 162, Poonamallee High Road, Chennai 600077 India 
 
Primary Sponsor  
Name  Ayesha Fathima S 
Address  162, Poonamallee High Road, Chennai 600077 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 
DrMahesh  Saveetha Dental College and Hospitals  Clinic 28, Department of Pediatric and Preventive Dentistry
Chennai
TAMIL NADU 		 9840322728

maheshpedo@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha Dental College & Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Edentulousness 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Space maintainer  Conventional space maintainer for 9 months 
Intervention  Space maintainer   Prefabricated space maintainer for 9 months 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  7.00 Year(s)
Gender  Both 
Details  Clinical criteria:
Systemically healthy children.
Grossly mutilated or resorbed primary molars bilaterally requiring extraction before the complete eruption of permanent mandibular anteriors.
Sound and healthy teeth adjacent to the extraction site.
No abnormal dental conditions such as crossbite, open bite,
and deep bite.
Radiographic criteria:
Presence of succedaneous tooth bud.
Presence of at least 1 mm bone overlying the succedaneous
Tooth germ with less than one-third of the root formed. 
 
ExclusionCriteria 
Details  Parents who didn’t give consent
Individuals having systemic diseases or severe medically compromised.
Grossly carious teeth were adjacent to the created space.
Absence of teeth on the mesial or distal side of the teeth to be extracted
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Survival rate  Baseline, 1 month, 3 months, 6 months and 9 months 
 
Secondary Outcome  
Outcome  TimePoints 
Gingival health, Incidence of caries in abutment tooth, Space loss  Baseline, 1 month, 3 months, 6 months and 9 months 
 
Target Sample Size   Total Sample Size="18"
Sample Size from India="18" 
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 3 
Date of First Enrollment (India)   29/02/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
In this split-mouth, randomized control trial, we aimed to compare the efficacy of two different space maintainers namely,  conventional and pre fabricated space maintainer. The study will assess survival rate, gingival health, incidence of caries in the abutment tooth, amount of space loss between both the space maintainers. All the parameters are evaluated at baseline, 1 month, 3 months, 6 months and  9 months.  The results of this trial will provide valuable insights into the impact of unilateral fixed space maintainers. aiding pedodontists in making informed decisions regarding the choice of space maintainer for improved patient outcomes and quality of care.
 
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