| 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
|
|
|
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
|
|
|
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. |