| CTRI Number |
CTRI/2025/08/093388 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ozonated Olive Oil in Primary Molars |
|
Scientific Title of Study
|
To Compare and Evaluate the Efficacy of Ozonated Olive Oil on Postoperative Pain Haemostasis Healing following Extraction in Primary Molar: 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 Namrata Jain |
| Designation |
PG STUDENT |
| Affiliation |
Hitkarini Dental College |
| Address |
967 Kotwali Ward Gurhai Gali Jabalpur Madhya Pradesh
ROOM NO. 8 GROUND FLOOR
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY
HITKARINI DENTAL COLLEGE AND HOSPITAL
HITKARINI HILLS DUMNA ROAD JABALPUR
HITKARINI HILLS DUMNA ROAD JABALPUR
HITKARINI HILLS DUMNA JABALPUR
Jabalpur
MADHYA PRADESH
482001
India |
| Phone |
7415265982 |
| Fax |
|
| Email |
drnamratajain16069@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Debapriya Pradhan |
| Designation |
Professor and Head |
| Affiliation |
Hitkarini Dental College |
| Address |
Block A Flat No 401 Aakash Paradise Society Bilhari Madhya Pradesh
ROOM NO. 8
GROUND FLOOR
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY
HITKARINI HILLS DUMNA JABALPUR
Jabalpur
MADHYA PRADESH
482020
India |
| Phone |
9619921116 |
| Fax |
|
| Email |
pradhandp@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Debapriya Pradhan |
| Designation |
Professor and Head |
| Affiliation |
Hitkarini Dental College |
| Address |
Block A Flat No 401 Aakash Paradise Society Bilhari Madhya Pradesh
ROOM NO. 8 GROUND FLOOR
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY
HITKARINI DENTAL COLLEGE AND HOSPITAL
HITKARINI HILLS DUMNA ROAD JABALPUR
Jabalpur
MADHYA PRADESH
482020
India |
| Phone |
9619921116 |
| Fax |
|
| Email |
pradhandp@hotmail.com |
|
|
Source of Monetary or Material Support
|
| BISLERI OZONE FORUM OF INDIA |
|
|
Primary Sponsor
|
| Name |
Hitkarini Dental College |
| Address |
Hitkarini hills Dumna Road Jabalpur |
| Type of Sponsor |
Private medical college |
|
|
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 |
| DrDebapriya Pradhan |
HITKARINI DENTAL COLLEGE AND HOSPITAL |
ROOM NO. 8 GROUND FLOOR
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY
HITKARINI DENTAL COLLEGE AND HOSPITAL
HITKARINI HILLS DUMNA ROAD JABALPUR
Jabalpur
MADHYA PRADESH |
9619921116
pradhandp@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CENTRAL ETHICS COMMITTEE ON HUMAN RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ICD-1 |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
IBUGESIC
AMOXCLAV |
Syp.Ibugesic 100 mg
TDS 5 ml
Spy. AMOXCLAV 228.5 mg
TDS 5ml |
| Intervention |
OZONATED OLIVE OIL |
Topical application with a clean cotton bud
TDS |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Children aged between 4 to 8 years.
Signed informed consent of parents or guardians for the participation of the children.
Children without any systemic disease.
Children without disability limitations.
Children with teeth involving abscess, pulpectomy failure, furcation involved, pathological root resorption, reinfection. |
|
| ExclusionCriteria |
| Details |
Children below 4 years or above 8 years of age.
Children whose parent/ guardians did not sign the statement of informed consent.
Children with any systemic disease.
Children with special disabilities/mentally disabled children. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain- VAS Scale-1 to 10
Healing- Very Poor to Excellent
Haemostasis-2 to 8 minutes |
Pain 6 hourly and 24 hourly
Pain and healing 3rd and 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
09/09/2025 |
| Date of Study Completion (India) |
10/01/2026 |
| Date of First Enrollment (Global) |
09/09/2025 |
| Date of Study Completion (Global) |
10/01/2026 |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The study is randomised controlled trial, parallel group, comparing and evaluating the efficacy of ozonated olive oil on post operative pain, healing and haemostasis following extractions in primary molars, that will be conducted in India. The primary outcomes will be to asses haemostasis after extraction, pain after 6 hourly and 24 hourly, pain and healing on 3rd and 7th day following extraction. |