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CTRI Number  CTRI/2025/05/087046 [Registered on: 16/05/2025] Trial Registered Prospectively
Last Modified On: 15/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Success rates of three different root canal filling materials in primary molars 
Scientific Title of Study   Clinical and radiographic evaluation of a mixture of zinc oxide nanohydroxyapatite powder with aloevera gel metapex and endoflas as obturating material in primary molars A randomized controlled study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Muppa Susmitha 
Designation  Post graduate student 
Affiliation  Kamineni Institute of Dental Sciences 
Address  Department of paediatric and preventive dentistry first floor room no 8
Sreepuram Narketpally
Nalgonda
TELANGANA
508254
India 
Phone  7995741589  
Fax    
Email  susmithareddymuppa@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr M Kiranmayi 
Designation  Professor 
Affiliation  Kamineni Institute of Dental Sciences 
Address  Department Of Paediatric And Preventive Dentistry First floor room no 8
Sreepuram Narketpally
Nalgonda
TELANGANA
508254
India 
Phone  8919425949  
Fax    
Email  kiranmayee30dec@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr M Kiranmayi 
Designation  Professor 
Affiliation  Kamineni Institute of Dental Sciences 
Address  Department of paediatric and preventive dentistry first floor room no 8
Sreepuram Narketpally
Nalgonda
TELANGANA
508254
India 
Phone  8919425949  
Fax    
Email  kiranmayee30dec@gmail.com  
 
Source of Monetary or Material Support  
Kamineni institute of dental sciences 
 
Primary Sponsor  
Name  Dr Muppa Susmitha 
Address  Kamineni institute of dental sciences 
Type of Sponsor  Other [NIL] 
 
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 Muppa Susmitha  Kamineni institute of dental sciences  Department of paediatric and preventive dentistry first floor room no 8
Nalgonda
TELANGANA 		 7995741589

susmithareddymuppa@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 
Healthy Human Volunteers  Primary molars with caries involving pulp 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Pulpectomy using various obturating materials in primary molars  Clinical and Radiographic evaluation of obturating materials in primary molars 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  History of spontaneous pain
Primary molars with caries involving the pulp
Presence of atleast 2/3rd of root length
Presence of inter/periapical radiolucency
Tooth that cannot be restorable 
 
ExclusionCriteria 
Details  Children with any underlying systemic diseases
Preshedding and abnormal pathologic mobility Any sinus opening or fistula
In case of internal or external resorption
Extensive inter/periapical radiolucency
Tooth that cannot be restorable
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To clinically and radiographically evaluate the success rate of a mixture of zinc oxide-nanohydroxyapatite powder with aloe vera gel as an obturating material in primary molars.
To clinically and radiographically evaluate the success rate of Metapex as an obturating material in primary molars.
To clinically and radiographically evaluate the success rate of Endoflas as an obturating material in primary molars.
To compare clinical and radiographic success rates of a mixture of zinc oxide-nanohydroxyapatite powder with aloe vera gel, Metapex, and Endoflas as obturating material in primary molars.
 		 To clinically and radiographically evaluate the success rate of a mixture of zinc oxide-nanohydroxyapatite powder with aloe vera gel as an obturating material in primary molars.
To clinically and radiographically evaluate the success rate of Metapex as an obturating material in primary molars.
To clinically and radiographically evaluate the success rate of Endoflas as an obturating material in primary molars.
To compare clinical and radiographic success rates of a mixture of zinc oxide-nanohydroxyapatite powder with aloe vera gel, Metapex, and Endoflas as obturating material in primary molars at three six nine months
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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 2 
Date of First Enrollment (India)   30/07/2025 
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="0"
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   Preservation of primary teeth is essential as they guide the permanent teeth, maintaining arch length and function. Endodontic treatment, specifically pulpectomy, is crucial for primary teeth with infected and necrotic pulp. Chemomechanical therapy alone often fails to disinfect all bacteria, necessitating a filling paste that is antibacterial, biocompatible, radiopaque, adheres to canal walls without voids, resorbable if it goes beyond the apex, easily removable when needed.  
 AIM OF THE STUDY The aim of the study is to evaluate the clinical and radiographic success rate of a mixture of Zinc oxide-nanohydroxyapatite powder with aloevera gel, Metapex, and Endoflas as obturating material in primary molars.
OBJECTIVES OF THE STUDY
 1)To clinically and radiographically evaluate the success rate of a mixture of Zinc oxide-nanohydroxyapatite powder with aloevera gel as an obturating material in primary molars. 
 2)To clinically and radiographically evaluate the success rate of Metapex as obturating material in primary molars. 
 3)To clinically and radiographically evaluate the success rate of Endoflas as obturating material in primary molars.
 4)To compare clinical and radiographic success rates of a mixture of Zinc oxide nanohydroxyapatite powder with alovera gel, Metapex, and Endoflas as obturating material in primary molars.
Group I– Metapex. Group II – Endoflas. Group III– Mixture of zinc oxide-nano hydroxyapatite powder with aloevera gel.
Post endodontic restoration with type - II Glass ionomer cement will be done followed by the placement of semi-permanent crowns after 1 month. Clinical evaluation will be done for pain, tenderness on percussion, gingival swelling or inflammation, mobility, presence of fistula or sinus opening. A postoperative digital radiograph will be taken for assessment of the obturation quality and will be categorized as underfilled, optimal filled, or overfilled canals, furcation or periapical radiolucency, extensive pathological root resorption. Both clinical and radiographic evaluation of the pulpectomy treated teeth will be carried out at 3, 6, and 9 months respectively.  
 
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