| CTRI Number |
CTRI/2026/03/106156 [Registered on: 13/03/2026] Trial Registered Prospectively |
| Last Modified On: |
13/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Study Comparing EDTA and Ozonated olive oil Effects on rotary instruments, Treatment Time and Pain |
|
Scientific Title of Study
|
Comparative Evaluation of Ozonated Olive
Oil and EDTA as Lubricants and their Impact on Instrumentation Time, Postoperative Pain and File Morphology during Pulpectomy: A 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 |
Dr Cherukuri Nikitha Saranya |
| Designation |
Post graduate |
| Affiliation |
GITAM Dental College and Hospital |
| Address |
1st Floor
Room no 3
Department of Pediatric and Preventive Dentistry
GITAM Dental College and Hospital
Rushikonda
Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
9052899232 |
| Fax |
|
| Email |
nikithasaranyacherukuri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jayalakshmi Pandranki |
| Designation |
Professor |
| Affiliation |
GITAM Dental College and Hospital |
| Address |
1st Floor
Room no 3
Department of Pediatric and Preventive Dentistry
GITAM Dental College and Hospital
Rushikonda
Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
9912860194 |
| Fax |
|
| Email |
mds.deepthi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayalakshmi Pandranki |
| Designation |
Professor |
| Affiliation |
GITAM Dental College and Hospital |
| Address |
1st Floor
Room no 3
Department of Pediatric and Preventive Dentistry
GITAM Dental College and Hospital
Rushikonda
Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
9912860194 |
| Fax |
|
| Email |
mds.deepthi@gmail.com |
|
|
Source of Monetary or Material Support
|
| GITAM Dental College and Hospital
Gandhinagar Campus
Rushikonda
Visakhapatnam
Andhra Pradesh
530045 |
|
|
Primary Sponsor
|
| Name |
Cherukuri Nikitha Saranya |
| Address |
GITAM Dental College and Hospital
Gandhinagar Campus
Rushikonda
Visakhapatnam
Andhra Pradesh
530045 |
| Type of Sponsor |
Other [Self] |
|
|
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 Cherukuri Nikitha Saranya |
GITAM Dental College and Hospital |
1st Floor
Room no 3
Department of Pediatric and Preventive Dentistry
GITAM Dental College and Hospital
Rushikonda
Visakhapatnam
Visakhapatnam
ANDHRA PRADESH |
09052899232
nikithasaranyacherukuri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUITIONAL ETHICAL COMMITTEE (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, (2) ICD-10 Condition: K041||Necrosis of pulp, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ethylenediaminetetraacetic acid |
17% Ethylenediaminetetraacetic acid (EDTA) solution used as an intracanal lubricant, approximately 0.5-1 mL per canal delivered using a syringe during rotary instrumentation, replenished between file changes, used throughout the biomechanical preparation phase |
| Intervention |
Ozonated Olive Oil |
Ozonated olive oil used as an intracanal lubricant during pulpectomy, approximately 0.5–1 mL introduced into each root canal using a disposable syringe during rotary instrumentation replenished as required between file changes, used throughout the biomechanical preparation phase |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy cooperative children aged 4-8 years
2.Mandibular primary molars with irreversible pulpitis devoid of any other diseased teeth in that quadrant that bothers the patient
3.No history of analgesic use 12 hours prior to pulpectomy
|
|
| ExclusionCriteria |
| Details |
1.Uncooperative children
2.Children with systemic illness
3.Teeth with clinical and radiographic contraindications for pulpectomy
|
|
|
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 |
Instrumentation time
|
assessed in minutes at the same day using stop watch from the beginning of rotary instrumentation till the end of preparation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative pain |
6 hours, 12 hours, 1st day, 3rd day and 7h day postoperatively |
| File Morphology evaluation under Scanned Electron Microsc0py |
each rotary file after using for every 5 teeth |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/04/2026 |
| 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="6"
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 is a prospective, randomized, double-blind controlled clinical trial
conducted over 6 months. It aims to compare Ozonated Olive Oil and 17% EDTA as
lubricants during pulpectomy in 40 children aged 4 to 8 years requiring
treatment in mandibular primary molars. Participants will be randomly assigned
into two groups with 20 in each group using a computer-generated randomization
method with allocation concealment.
The
study evaluates three main outcomes that includes instrumentation time which is
recorded from glide path establishment to completion of rotary canal
preparation, postoperative pain which is assessed at 6 hours, 12 hours, 1st,
3rd, and 7th day using the Modified Wong–Baker FACES Pain Rating Scale, and
surface topographical changes of rotary files which is analyzed after every 5
teeth. Ethical clearance has been obtained, and written informed consent
and assent will be secured before participation. Obturation will be performed
on the seventh day using zinc oxide–ozonated olive oil paste following pain
assessment.
|