| CTRI Number |
CTRI/2026/03/106411 [Registered on: 17/03/2026] Trial Registered Prospectively |
| Last Modified On: |
17/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical trial Comparing Different Filling Techniques for Zinc Oxide mixed with Ozonated Olive Oil as Filling material in Primary Teeth |
|
Scientific Title of Study
|
Comparative Clinical and Radiographic evaluation of Zinc oxide Ozonated Olive Oil as Obturation material in Primary molars with different Obturation techniques: 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 Cherukuri Nikitha Saranya |
| Designation |
Post graduate |
| Affiliation |
GITAM Dental College and Hospital |
| Address |
GITAM Dental College and Hospital
Department of Pediatric and Preventive dentistry
1st floor
Room no 3
Gandhinagar Campus
Rushikonda
Visakhapatnam
Andhra Pradesh
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
09052899232 |
| Fax |
|
| Email |
nikithasaranyacherukuri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayalakshmi Pandranki |
| Designation |
Professor |
| Affiliation |
GITAM Dental College and Hospital |
| Address |
GITAM Dental College and Hospital
Department of Pediatric and Preventive dentistry
1st floor
Room no 3
Gandhinagar Campus
Rushikonda
Visakhapatnam
Andhra Pradesh
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 |
GITAM Dental College and Hospital
Department of Pediatric and Preventive dentistry
1st floor
Room no 3
Gandhinagar Campus
Rushikonda
Visakhapatnam
Andhra Pradesh
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 - 530045
Andhra Pradesh
India |
|
|
Primary Sponsor
|
| Name |
Cherukuri Nikitha Saranya |
| Address |
GITAM Dental College and Hospital
Gandhinagar Campus
Rushikonda
Visakhapatnam - 530045
Andhra Pradesh
India |
| 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 |
Department of Pediatric and Preventive Dentistry
1st floor
Room no 3
Gandhinagar Campus
Rushikonda
Visakhapatnam
530045
Andhra Pradesh
India
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 |
Lentulo spiral |
Root canals will be obturated using a Lentulo spiral mounted on a slow-speed handpiece to deliver a mixture of zinc oxide powder and ozonated olive oil into the prepared root canals of primary molars. The Lentulo spiral will be inserted into the canal 1mm short of apex and rotated at low speed to ensure uniform distribution of the obturating material. The procedure will be repeated until the canal is adequately filled |
| Intervention |
Navitip |
Root canals of primary molars will be obturated using a Navitip needle attached to a syringe to deliver a mixture of zinc oxide powder and ozonated olive oil into the prepared canals. The Navitip needle will be inserted passively into the canal up to 1mm short of apex, and the obturating material will be slowly injected while gradually withdrawing the needle to ensure uniform filling of the canal space |
|
|
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 |
| Radiographic evaluation of the level of obturation as optimal fil or under fil or overfil |
as baseline immediately after obturation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Radiographic volumetric analysis of the root canals |
immediately after obturation |
| Clinical evaluation of pain and associated pathological symptoms |
1 month, 3 months and 6 months |
| Radiographic changes in the periapical tissues |
1 month, 3 months and 6 months |
|
|
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 randomized, double-blind, parallel-group in vivo clinical trial evaluating zinc oxide mixed with ozonated olive oil as an obturation material in primary mandibular molars of children aged 4–8 years. A total of 40 children requiring pulpectomy will be included and randomly allocated into two groups, 20 in each. The intervention group will receive obturation using the Navitip syringe technique to deliver the zinc oxide–ozonated olive oil mixture into the prepared canals. The comparator group will receive obturation using the Lentulo spiral technique with the same obturating material. The primary outcome includes evaluation of the quality of obturation in terms of fil that includes optimal fil, underfil, or overfil)and presence of voids. Secondary outcomes will include clinical and radiographic evaluation of obturation quality based on length of filling and the presence of voids during follow-up. |