Efficacy of Sodium Hypochlorite, Chitosan and Chlorhexidine Gluconate as non-activated and Endo-Activator activated irrigants on Microbial Load, Obturation Quality and Post-Endodontic Pain In Primary Teeth- A Randomized Comparative Clinical Study

Efficacy of Sodium Hypochlorite, Chitosan and Chlorhexidine Gluconate as non-activated and Endo-Activator activated irrigants on Microbial Load, Obturation Quality and Post-Endodontic Pain In Primary Teeth- A Randomized Comparative Clinical Study - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/085249

Enrollment

Registered

2025-04-21

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

Health Condition 1: K029- Dental caries, unspecified

Interventions

Intervention1: Chitosan irrigating solution: Approximately 10ml of 0.2% chitosan irrigating solution in total with each sequential file change in pulp therapy of primary teeth Control Intervention1: S

Eligibility

Inclusion criteria

Inclusion criteria: 1.systemically healthy children requiring pulpectomy within age range of 5-9 years 2.primary maxillary or mandibular molars with pulp necrosis 3.teeth with intact roots or less than 1/3rd of physiological root resorption 4.teeth with no periodontal pockets or operative intervention of the root canals 5.Patients with informed legal consent form guardians/parents 6.patients with no significant systemic conditions or any known allergy to any irrigating agent used in our study 7.Physiological root resorption not more than Apical 1/3rd of root surface. 8.No signs of internal resorption/ external resorption. 9.Caries involving enamel, dentin and pulp

Exclusion criteria

Exclusion criteria: 1.Teeth with excessive root resorption and mobility teeth requiring pulp therapy due to periodontal problems, developmental anomalies or traumatic injuries 2.children with special health care conditions 3.Children with systemic diseases and patients undergone antibiotic therapy in the past 3 months 4.Patients/ parents/ legal guardians who refuse to give consent

Design outcomes

Primary

Measure	Time frame
Anti-microbial efficacy using Colony forming unit(CFU) count in thioglycollate broth in non-activated and activated groupTimepoint: During the treatment: (Baseline) Pre- irrigant (S1) Post- irrigant (S2)	—

Secondary

Measure	Time frame
The Post operative pain scores will be evaluated using Wong Baker s scaleTimepoint: Immediately post-treatment, 24 hours, 7 days;Obturation quality using Coll and Sadrian (1996)Timepoint: Immediately post-treatment	—

Countries

India

Contacts

Public ContactDr Megha Patel

Karnavati School of Dentistry

meghapatel@karnavatiuniversity.edu.in9824400464

Outcome results

None listed

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