Comparing the Effect of Chitosan Nanoparticles and Calcium Hydroxide on Post-Operative Pain in Endodontic Patients

Comparative Analysis of Chitosan Nanoparticle and Calcium Hydroxide as intracanal medicament on post-operative pain in symptomatic endodontic patients A Randomized Control Trial - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/108448

Enrollment

Registered

2026-04-15

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

Health Condition 1: K049- Other and unspecified diseases ofpulp and periapical tissues

Interventions

Intervention1: Chitosan Nanoparticle (CSNP) Intracanal Medicament: Chitosan nanoparticle-based intracanal medicament will be placed in the root canal after completion of biomechanical preparation in s

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age: 18 40 years 2. Patient with presenting with pain. 3. Necrotic pulp and symptomatic or apical periodontitis with apical radiolucency less than or equal to 2mm. 4. Restorability & periodontium: Tooth restorable; Periodontal Probing Depth less than or equal to 4mm, mobility less than or equal to Grade 1. 5. Tooth with mature apex 6. Root canal negotiable to Working Length. 7. Consent & compliance: Written informed consent; adherence to pain-recording schedule. 8. Tooth with no previous root canal treatment.

Exclusion criteria

Exclusion criteria: 1. Presence of cellulitis with extra-oral inflammation. 2. Vertical root fracture or suspected crack. 3. Severe periodontal disease (Probing Depth more than 5mm, mobility more than Grade 1) or combined perio-endo lesions. 4. Tooth presenting with open apex, severe canal calcification/obliteration, root resorption (internal/external), transportation/perforation, ledge preventing working length control. 5. Immunocompromised patient 6. Diabetic patient 7. Pregnant/lactating. 8. Radiotherapy to the jaws. 9. Medications: Systemic antibiotics or anti-inflammatories within 48 72 h pre-op, chronic analgesic/opioid use. 10. Allergy/intolerance: Known allergy to chitosan/shellfish, propylene glycol, acetic acid, sodium hypochlorite, or study excipients. 11. Recent surgery on the target tooth; non-restorable tooth or hopeless prognosis. 12. Peri-Apical Lesion greater than 2mm

Design outcomes

Primary

Measure	Time frame
To evaluate and compare the post-operative pain following intracanal placement of chitosan nanoparticles and calcium hydroxide in symptomatic primary root canal treatment cases at different time intervals.Timepoint: Preoperative (Baseline) 6 hours 24 hours 48 hours 72 hours	—

Secondary

Measure	Time frame
NILTimepoint: NIL	—

Countries

India

Contacts

Public ContactDr ISHA MALIK

I.T.S Dental College Hospital And Research Centre, Greater Noida

hod.cons.gn@its.edu.in9711895616

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026