FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/03/105905 [Registered on: 11/03/2026] Trial Registered Prospectively
Last Modified On: 11/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical study comparing success of root canal treatment using zinc oxide–ozonated oil and Endoflas for filling root canals of molar teeth in children. 
Scientific Title of Study   Comparative evaluation of Zinc oxide-Ozonated oil and Endoflas as root canal filling materials in primary molars: an in-vivo 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 Vinaya Kumar Kulkarni  
Designation  Professor and HOD  
Affiliation  SMBT Dental College and Hospital, Sangamner 
Address  Department of Pediatric and Preventive Dentistry, SMBT Dental College and Hospital, Sangamner
Amrutnagar, Ghulewadi, Sangamner.
Ahmadnagar
MAHARASHTRA
422608
India 
Phone  8830483436  
Fax    
Email  vinayakumar53@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Sharvari Ingle 
Designation  PG student 
Affiliation  SMBT Dental College and Hospital, Sangamner 
Address  Department of Pediatric and Preventive Dentistry, SMBT Dental College and Hospital, Sangamner
Amrutnagar, Ghulewadi, Sangamner.
Ahmadnagar
MAHARASHTRA
422608
India 
Phone  9920979464  
Fax    
Email  sharvariingle@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vinaya Kumar Kulkarni  
Designation  Professor and HOD  
Affiliation  SMBT Dental College and Hospital, Sangamner 
Address  Department of Pediatric and Preventive Dentistry, SMBT Dental College and Hospital, Sangamner
Amrutnagar, Ghulewadi, Sangamner.
Ahmadnagar
MAHARASHTRA
422608
India 
Phone  8830483436  
Fax    
Email  vinayakumar53@gmail.com  
 
Source of Monetary or Material Support  
SMBT Dental College and Hospital, Ghulewadi, Amurtnagar, Sangamner-422608 Maharashtra, India 
 
Primary Sponsor  
Name  SMBT Dental College and Hospital 
Address  Ghulewadi, Amurtnagar, Sangamner-422608 Maharashtra, India 
Type of Sponsor  Other [Private dental college and hospital.] 
 
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 Vinaya Kumar Kulkarni  SMBT Dental College and Hospital  Department of Pediatric and Preventive Dentistry, Room No 102, Amrutnagar, Ghulewadi, Sangamner-422608.
Ahmadnagar
MAHARASHTRA 
8830483436

vinayakumar53@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Committee on Ethics, SMBT Dental College and Hospital, Sangamner  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Endoflas  Root canals of the indicated tooth will be obturated only once on contralateral side of the patient using Endoflas paste mixed in the powder/liquid ratio of 3:1 and will be followed up at 3rd, 6th and 9th month interval. 
Intervention  Zinc Oxide Ozonated Oil   Root canals of the indicated tooth will be obturated only once, on one side of the patient with the paste prepared by mixing Zinc oxide powder with Ozonated oil in the powder/liquid ratio of 4:1 and will be followed up at 3rd, 6th and 9th month interval. 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  Children in the age group of 4-8 years
Children with primary molars showing signs and symptoms of
irreversible pulpitis or necrosis (with or without periradicular infection,
extraoral or intraoral swelling, sinus opening, grade I mobility)
Primary molars having more than 2/3rd of root remaining
Children whose parents will give consent for the study 
 
ExclusionCriteria 
Details  Non-restorable primary molar
Primary molar with mechanical or carious perforation of the floor of
pulp chamber
Presence of radicular cyst
Primary molars exhibiting greater than grade I mobility
Traumatized teeth with vertical fracture26
Presence of pathologic internal or external root resorption
Children who have significant medical history
Specially-abled children
Children who will be participating in another clinical trial 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Clinical and radiographic success of pulpectomy using two root canal filling materials (Zinc oxide–ozonated oil and Endoflas) in primary molars.  The success will be evaluated at 3, 6, and 9 months follow-up 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
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)   23/03/2026 
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="1"
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  

This study will be conducted to evaluate and compare the clinical and radiographic outcomes of two root canal filling materials, zinc oxide–ozonated oil and Endoflas, in pulpectomy procedures performed in primary molars. Pulpectomy is commonly indicated in primary teeth with irreversible pulpitis or necrotic pulp; however, the ideal obturating material should possess antimicrobial properties, biocompatibility, and the ability to resorb in harmony with the physiological root resorption of primary teeth.

In this randomized clinical trial, children requiring pulpectomy in primary molars will be recruited and randomly allocated into two groups. Following standard biomechanical preparation of the root canals, the canals will be obturated with either zinc oxide–ozonated oil or Endoflas according to the assigned group.

The treated teeth will be evaluated for clinical and radiographic success at predetermined follow-up intervals of 3, 6, and 9 months. Clinical parameters such as pain, swelling, sinus tract, abnormal mobility, and tenderness to percussion will be assessed, while radiographic evaluation will include assessment of periapical or furcation radiolucency, pathological root resorption, and signs of healing.

The findings of this study will help determine whether zinc oxide–ozonated oil can serve as an effective alternative to Endoflas as an obturating material in pulpectomy of primary molars.

 
Close