| CTRI Number |
CTRI/2025/03/081790 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
05/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Zinc Oxide Eugenol and Biosealer for Primary Tooth Root Canal Treatment: A Clinical Study |
|
Scientific Title of Study
|
Clinical and Radiographic Evaluation of Zinc Oxide Eugenol and Biosealer as Obturating Material in Primary Teeth: An In-Vivo Comparative Study |
| Trial Acronym |
ZOE-BioSeal Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrChaya Chhabra |
| Designation |
Professor and Head |
| Affiliation |
NIMS University |
| Address |
Department of Pediatric and Preventive Dentistry
NIMS Dental College NIMS University
NIL
Jaipur
RAJASTHAN
303121
India |
| Phone |
9929535666 |
| Fax |
|
| Email |
chaya.chhabra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Khushbu |
| Designation |
Postgraduate |
| Affiliation |
NIMS University |
| Address |
room no 7 Department of Pediatric and Preventive Dentistry
NIMS Dental College NIMS University
NIL
Jaipur
RAJASTHAN
303121
India |
| Phone |
09879550215 |
| Fax |
|
| Email |
khushbusoni861@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrChaya Chhabra |
| Designation |
Professor and Head |
| Affiliation |
NIMS University |
| Address |
Department of Pediatric and Preventive Dentistry
NIMS Dental College NIMS University
NIL
Jaipur
RAJASTHAN
303121
India |
| Phone |
9929535666 |
| Fax |
|
| Email |
chaya.chhabra@gmail.com |
|
|
Source of Monetary or Material Support
|
| NIMS Dental College and Hospital NIMS University Jaipur Rajasthan |
|
|
Primary Sponsor
|
| Name |
DrKhushbu |
| Address |
Camellia Girls Hostel 1401 Nims University Jaipur Rajasthan 303121 |
| Type of Sponsor |
Other [self funded] |
|
|
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 Chaya Chhabra |
NIMS Dental College and Hospital Jaipur Rajasthan |
Room No 7, Postgraduate Clinic Department of Pediatric & Preventive Dentistry ,NIMS Dental College & Hospital , NIMS University Jaipur Rajasthan-303121
Jaipur
RAJASTHAN |
9929535666
chaya.chhabra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMS UNIVERSITY |
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 |
| Intervention |
Biosealer |
Biosealer is assesed as potential obturating material by clinically and radiographically at baseline and follow up will be done after a week |
| Comparator Agent |
Zinc Oxide Eugenol |
Zinc Oxide Eugenol will be assessed as a gold standard obturating material in pulpectomy procedure at baseline and followed up after a week |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1. Children aged between 4-9 years
2. Primary teeth with chronic pulpitis with periapical abcess
3. Primary molars with minimal mobility and restorable crown
4. Minimal root resorption
5. No sinus tract
6. Parents/caregivers acceptance and cooperation.
|
|
| ExclusionCriteria |
| Details |
1. Primary molar with mobility and unrestorable crown
2. Sinus tract present
3. Teeth having furcal lesions more than 5 mm diameter or periapical lesions exceeding 10 mm diameter
4. Children with systemic diseases and patients undergone antibiotic therapy in the past 3 months
5. Children whose parents have refused to participate in the study
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The ability to achieve a proper seal and absence of periapical radiolucencies, indicating effective filling and prevention of reinfection. |
The ability to achieve a proper seal and absence of periapical radiolucencies, indicating effective filling and prevention of reinfection at baseline, 1 week, 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcomes of the study evaluating zinc oxide eugenol (ZOE) and biosealer as obturating materials in primary teeth include the assessment of post-treatment symptoms, such as discomfort or complications; the radiographic quality of the obturation, focusing on any voids or gaps; biocompatibility, including any adverse tissue reactions; the longevity of treatment, monitoring the durability of the obturation and the need for retreatment; and parent/patient satisfaction regarding the overall treatment experience. |
baseline |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/04/2025 |
| 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 evaluates the clinical and radiographic effectiveness of zinc oxide eugenol (ZOE) and a biosealer as obturating materials in primary teeth. Researchers assessed factors such as sealing ability, biocompatibility, and overall success rates of both materials. The findings indicate that while ZOE has a long-standing history of use, the biosealer shows promising results in terms of adaptability and sealing properties. The study aims to provide insights into the best practices for endodontic treatments in pediatric dentistry, highlighting the potential for improved outcomes using modern materials. |