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Comparing Two Root Canal Filling Materials Endoflas and Petasin-Mixed Endoflas to Reduce Pain After Treatment in Children Aged 6 8 Years

Comparative Evaluation of the Effectiveness of Endoflas and Petasin-Mixed Endoflas for Managing Immediate Post-Obturation Pain in Children Aged 6 8 Years: A Randomized Controlled Trial. - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/099107
Enrollment
56
Registered
2025-12-15
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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: Petasin-Mixed Endoflas: Petasin is a natural extract from Petasites hybridus known for its strong anti-inflammatory and analgesic properties. In this study, 15% Petasin extract powder (
Batch No. 20085617) is mixed with Endoflas powder in a 1:2 ratio. The combined powder is then mixed with Endoflas liquid to achieve a uniform paste. This Petasin-modified Endoflas is used as the exper

Sponsors

Dr Snehal Jagtap
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 6 to 8 years with Frankl Behaviour Rating Scale scores of 3 or 4 (indicating positive to definitely positive behavior) Patients diagnosed with Symptomatic Irreversible Pulpitis (SIP) in the second primary molar planned for pulpectomy Only vital teeth showing active bleeding upon access opening will be included Parents or legal guardians who provide informed consent and are willing to participate in the study Radiographic evidence of intact root structure without signs of internal or pathological external root resorption and no periapical or furcation radiolucency

Exclusion criteria

Exclusion criteria: Children with Frankl Behaviour Rating Scale scores of 1 or 2 (negative or definitely negative behavior) Children with systemic illnesses or those requiring special health care Teeth with signs of acute or chronic apical abscess/periodontitis tenderness on percussion (TOP) with or without a sinus tract Teeth with previous root canal treatment or filled canals Radiographic signs of internal resorption, pathological root resorption or presence of periapical or furcation radiolucency Cases diagnosed with necrotic pulp Medically compromised patients or those with a history of analgesic, steroid or antibiotic intake within the last 48 hours Parents or guardians unwilling to participate in the study

Design outcomes

Primary

MeasureTime frame
Post-obturation PainTimepoint: Post-obturation pain will be assessed at five time points, after obturation: immediately, 20 minutes, 6 hours, 12 hours, and 24 hours

Secondary

MeasureTime frame
NilTimepoint: Nil

Countries

India

Contacts

Public ContactDr Snehal Jagtap

GOVERNMENT DENTAL COLLEGE AND HOSPITAL NAGPUR

riteshpedo1@gmail.com8550938585

Outcome results

None listed

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