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Evaluating Chitosan Nanoparticle Intracanal Medicament in Comparison with Calcium Hydroxide for Pain and Healing Outcomes

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/06/111721
Enrollment
20
Registered
2026-06-02
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

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

Sponsors

I.T.S Dental College Hospital And Research Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Common Inclusion Criteria for Both Groups Age: 18 to 65 years Patient with pain Tooth restorable and periodontal support adequate (Periodontal Probing Depth less than or equal to 4 mm, mobility less than or equal to Grade I) Working length attainable or Root canal negotiable to working length Tooth with closed or mature apex Consent & compliance: Written informed consent; willing to attend all visits and record pain scores (VAS at 6, 24, 48, and 72 hours) and adherence to pain-recording schedule Additional Inclusion Criteria for Retreatment Cases Teeth with irreversible pulpitis Patients with normal pain threshold Previously endodontically treated teeth presenting with post-treatment disease (e.g., symptomatic apical periodontitis or radiographic apical radiolucency less than or equal to 5 mm) Additional Inclusion Criteria for Primary RCT Cases Primary endodontic treatment indicated for single rooted teeth Necrotic pulp and symptomatic or asymptomatic apical periodontitis with apical radiolucency less than or equal to 5 mm Tooth with no previous root canal treatment

Exclusion criteria

Exclusion criteria: Common Exclusion Criteria for Both Groups Acute swelling/abscess requiring incision and drainage or immediate antibiotics. Presence of sinus tract of non-endodontic origin (example trauma, surgery, foreign object, chronic persistent infection, etc). Vertical root fracture or suspected crack. Severe periodontal disease (Periodontal probing Depth more than 5 mm, mobility more than Grade I) or combined perio-endo lesions. Tooth presenting with open apex, severe canal calcification or obliteration, root resorption (internal or external), transportation or perforation, or ledge preventing working length control. Immunocompromised patient. Diabetic patient. Pregnant or lactating patient. History of radiotherapy to the jaws. Systemic antibiotics or anti-inflammatory medications within 48 72 hours pre-operatively, or chronic analgesic or opioid use. Known allergy or intolerance to chitosan or shellfish, propylene glycol, acetic acid, sodium hypochlorite, chlorhexidine, or study excipients. Recent surgery on the target tooth. Non-restorable tooth or tooth with hopeless prognosis. Periapical lesion greater than 5 mm

Design outcomes

Primary

MeasureTime frame
To assess and compare the postoperative pain levels and periapical healing response following the use of chitosan nanoparticle paste and calcium hydroxide as intracanal medicaments. To assess and compare the postoperative pain levels and periapical healing response following the use of chitosan nanoparticle paste and calcium hydroxide as intracanal medicaments at different time intervals (Preop, 6h, 24h and 72h) Timepoint: To assess and compare the postoperative pain levels and periapical healing response following the use of chitosan nanoparticle paste and calcium hydroxide as intracanal medicaments. To assess and compare the postoperative pain levels and periapical healing response following the use of chitosan nanoparticle paste and calcium hydroxide as intracanal medicaments at different time intervals (Preop, 6h, 24h and 72h)

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactDr ROHIT KOCHHAR

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

hod.cons.gn@its.edu.in9810034451

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026