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Testing a new tooth filling material for big cavities in baby teeth: a study on how safe and how well it works

Comparative evaluation of antimicrobial Efficacy, cytotoxicity, clinical and radiographic Outcomes of different Calcium Hydroxide Iodoform Combinations in Primary Root Canals. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/091063
Enrollment
80
Registered
2025-07-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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: Neopex Iodotin Dentocal : The canals will be obturated using respective calcium hydroxide-based materials in uniform consistency along with the quantity of the material according to the

Sponsors

Dr. K. Pranitha
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 4 8 years. Primary molars with irreversible pulpitis or non-vital pulp. Teeth with adequate root structure for obturation. Absence of periapical pathology beyond physiological resorption limits. Cooperative children for clinical follow-up.

Exclusion criteria

Exclusion criteria: Medically compromised children. Teeth with grossly destructed crown structures. Presence of internal/external resorption beyond repairable limits. Non-restorable teeth require extraction. History of previous endodontic treatment.

Design outcomes

Primary

MeasureTime frame
Criteria for Clinical Success No abnormal mobility. Absence of pain on percussion/tenderness. Teeth should present with no gingival swelling. No sinus opening in the oral mucosa or purulent exudates oozing from the gingival margin. Criteria for Radiographic Success No evidence of extensive pathologic root resorption/internal root resorption Reduction or no change in preoperative pathologic inter-radicular and/or periapical radiolucency No evidence of development of new postoperative pathologic radiolucency involving the succedaneous tooth germ Timepoint: 3,6,9 months

Secondary

MeasureTime frame
nilTimepoint:

Countries

India

Contacts

Public ContactDr K Pranitha

Sibar Institute of Dental Sciences

saisamata@gmail.com9346550646

Outcome results

None listed

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