Pain Assessment during and after Non-surgical Root Canal Treatment using XP-Endo Shaper Plus Sequence and Trunatomy Rotary Endodontic File: A Randomised Controlled Trial

Per-operative and post-operative pain assessment after using XP-Endo Shaper Plus Sequence and Trunatomy rotary endodontic file for non-surgical root canal treatment: A randomised controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/05/066831

Enrollment

Registered

2024-05-06

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Health Condition 1: R52- Pain, unspecified Health Condition 2: K040- Pulpitis

Interventions

Intervention1: XP-Endo Shaper Plus Sequence Endodontic File: Speed: 800 rpm Torque: 1 Ncm Frequency: 4-5 strokes Route of administration: Intracanal Duration: 2 minutes Intervention2: Trunatomy endodo

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient without any systemic disease 2. Teeth with fully formed mature roots 3. Patient diagnosed with Symptomatic Irreversible Pulpitis in single rooted premolars 4. Teeth with canal curvature less than 30 degree 5. Teeth which are not tender on percussion 6. Teeth without any periapical lesion

Exclusion criteria

Exclusion criteria: 1. Patient with uncontrolled systemic disease, co-morbidities 2. Patient with known allergies to local anaesthesia, sodium hypochlorite, analgesics 3. Pregnant and lactating patient 4. Patient with a history of medication (analgesic, antibiotic) 15 days before operation 5. Teeth with multiple roots, complex root canal anatomy, calcified canals 6. Teeth with root caries 7. Non-vital teeth 8. Case of previous endodontic treatment 9. Teeth with immature/open apex 10. Teeth showing root resorption 11. Teeth with periapical radiolucent lesion, sinus tract, abscess, facial cellulitis

Design outcomes

Primary

Measure	Time frame
1. Incidence of pain following root canal instrumentation using XP-Endo Shaper Plus File 2. Incidence of pain following root canal instrumentation using TruNatomy file system 3. Comparative evaluation of pain experienced following root canal instrumentation using XP-Endo Shaper Plus and TruNatomy file systemTimepoint: Pain will be assessed at following time intervals- immediately after biomechanical preparation, 24 hours, 3 days, 7 days	—

Measure

Time frame

1. Incidence of pain following root canal instrumentation using XP-Endo Shaper Plus File 2. Incidence of pain following root canal instrumentation using TruNatomy file system 3. Comparative evaluation of pain experienced following root canal instrumentation using XP-Endo Shaper Plus and TruNatomy file systemTimepoint: Pain will be assessed at following time intervals- immediately after biomechanical preparation, 24 hours, 3 days, 7 days

—

Secondary

Measure	Time frame
Comparative evaluation of pain experienced following root canal instrumentation using XP-Endo Shaper Plus and TruNatomy file systemTimepoint: Immediately after BMP, 24 HOURS, 3 days, 7 days	—

Countries

India

Contacts

Public ContactSuhina Roy Chowdhury

Guru Nanak Institute of Dental Sciences and Research

head_cons.gnidsr@jisgroup.org9831029606

Outcome results

None listed

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