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Optimizing Pulpectomy: A Battle of Obturants in Primary Molars

Comparative Analysis of Obturation Outcomes in Primary Mandibular Molar using Novel Obturating Material versus Iodocal versus Zinc Oxide Eugenol . A Randomised Controlled Clinical Trial

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/084603
Enrollment
30
Registered
2025-04-11
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

None listed

Interventions

Intervention1: Novel obturating material: New experimental material with enhanced sealing ability, antibacterial properties, and optimal resorption. Control Intervention1: Iodocal: Commonly used past

Sponsors

Pragati Pareek
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The inclusion criteria for this study require children aged 3 to 9 years who need pulpectomy in primary mandibular molars. Eligible teeth must have non-vital or irreversibly inflamed pulp, sufficient crown structure for restoration, and radiographic findings showing non-perforated pulpal involvement with minimal root resorption (less than one-third of root length). Systemically healthy children with no medical contraindications to dental treatment will be included, provided their parents or guardians give written informed consent.

Exclusion criteria

Exclusion criteria: Exclusion criteria include grossly decayed teeth with inadequate structure for restoration, perforated pulpal floors, or extensive internal/external root resorption exceeding one-third of the root length. Teeth with advanced periapical pathology, such as cystic lesions, will also be excluded. Systemic conditions such as immunocompromised states, bleeding disorders, or metabolic diseases will disqualify participants, as well as any known allergies to the obturation materials. Uncooperative children requiring sedation or general anesthesia will not be included. Additionally, teeth that have undergone previous pulpectomy or other endodontic treatments will be excluded. Lastly, children whose parents or guardians cannot commit to follow-up visits will not be eligible for participation.

Design outcomes

Primary

MeasureTime frame
Quality of obturation (radiographic evaluation for voids and density).baseline, 3 months,6 months,9 months,12 months Timepoint: Quality of obturation (radiographic evaluation for voids and density). baseline, 3 months,6 months,9 months,12 months

Secondary

MeasureTime frame
Clinical success (absence of pain, swelling, sinus tract). Radiographic success (resolution of pathology, periapical healing). Root resorption (timing and pattern of material resorption). Timepoint: Baseline , 1 months , 3 months, 6 months, 9 months , 12 months

Countries

India

Contacts

Public ContactPragati Pareek

Saveetha Dental College

Glaavuu@gmail.com9047605630

Outcome results

None listed

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