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Comparing Zinc Oxide Eugenol and Biosealer for Primary Tooth Root Canal Treatment: A Clinical Study

Clinical and Radiographic Evaluation of Zinc Oxide Eugenol and Biosealer as Obturating Material in Primary Teeth: An In-Vivo Comparative Study - ZOE-BioSeal Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/081790
Enrollment
60
Registered
2025-03-06
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K040- Pulpitis

Interventions

Intervention1: Biosealer: Biosealer is assesed as potential obturating material by clinically and radiographically at baseline and follow up will be done after a week Control Intervention1: Zinc Oxide

Sponsors

DrKhushbu
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
The ability to achieve a proper seal and absence of periapical radiolucencies, indicating effective filling and prevention of reinfection.Timepoint: 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

MeasureTime frame
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.Timepoint: baseline

Countries

India

Contacts

Public ContactDrChaya Chhabra

NIMS University

khushbusoni861@gmail.com09879550215

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026