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Comparative study between effectiveness of two cleaning and shaping instruments XP Endo file system and Hyflex EDM file system in pain reduction during root canal treatment

Comparative evaluation of postoperative pain intensity following chemomechanical preparation using XP Endo and Hyflex EDM file systems in teeth diagnosed with Irreversible pulpitis with symptomatic apical periodontitis: A randomized controlled clinical study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/107963
Enrollment
48
Registered
2026-04-09
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: K040- Pulpitis

Interventions

Intervention1: HYFLEX EDM rotary file system: Minimally invasive file system manufactured by electric discharge machining Control Intervention1: XPEndo rotary file system: It is a newly designed file

Sponsors

Dr.Rutvi Karande
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients (ASA I-II) requiring non-surgical root canal therapy. Teeth diagnosed clinically and radiographically with symptomatic irreversible pulpitis with symptomatic apical periodontitis. Single rooted premolars.

Exclusion criteria

Exclusion criteria: Pregnant or lactating patients. Patients with systemic medical conditions potentially influencing pain perception (e.g., diabetes mellitus, neurological disorders, immunocompromised status). Patients taking analgesics or anti-inflammatory medication within 24 hours prior to treatment. Teeth requiring retreatment. Patients with periodontal diseases, swelling or abscess, open apices or any periapical lesion. Patients having bruxism or clenching

Design outcomes

Primary

MeasureTime frame
PainTimepoint: preoperative 6 hours 24 hours 48 hours 7days—

Secondary

MeasureTime frame
NILTimepoint: NIL—

Countries

India

Contacts

Public ContactRutvi Karande

K.M.Shah dental college and Hospital

drajayinendo8385017307

Outcome results

None listed

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