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

Phase 4

Completed

• Conditions: Pain, unspecified, (2) ICD-10 Condition: K040||Pulpitis,

• Registration Number: CTRI/2024/05/066831
• Lead Sponsor: Guru Nanak Institute of Dental Sciences and Research

Brief Summary

AIM OF THE STUDY: To evaluate and compare incidence of pain during and after non-surgical endodontic treatment of teeth with symptomatic irreversible pulpitis using XP-Endo shaper plus and TruNatomy file system

MATERIALS AND METHODS:

The study is designed as a prospective, randomized, double blinded, clinical trial. 40 patients will be enrolled from the Department of Conservative Dentistry and Endodontics who are systemically healthy between 15-40 years of age and fulfilling the inclusion criteria of the study. Patient will be randomly assigned into two equal groups using Simple Random Sampling by rolling a dice. Odd number will be assigned to Group 1 (1,3,5) and even number will be assigned to Group 2 (2,4,6).

Group 1: Instrumentation using XP-Endo Shaper plus sequence

Group 2: Instrumentation using Trunatomy file sequence

Patient and outcome assessor will be blinded to the groups of the study. The randomized order of instrumentation procedure will be enclosed in sealed, opaque envelopes. Treatment will be carried out in 2 visits. In first visit, root canal treatment will be performed upto biomechanical preparation. In group 1, instrumentation will be done with XP-Endo shaper plus and in group 2, instrumentation will be done with Trunatomy file system. In the 2nd visit, obturation will be done. Each of the 40 patients, will be taught how to use VAS scale. On a scale of 1-10, the patient will be asked to rate their pain. Pain will be evaluated at following time intervals: immediately after BMP, 24 hours, 3 days, 7 days.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-15
• Last Update Posted: 2025-01-22
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patient without any systemic disease 2.
• 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

• 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 with periapical radiolucent lesion, sinus tract, abscess, facial cellulitis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Comparative evaluation of pain experienced following root canal instrumentation using XP-Endo Shaper Plus and TruNatomy file system	Immediately after BMP, 24 HOURS, 3 days, 7 days

Trial Locations

Locations (1)

Guru Nanak Institute of Dental Sciences and Research; 🇮🇳 Kolkata, WEST BENGAL, India

Guru Nanak Institute of Dental Sciences and Research

🇮🇳Kolkata, WEST BENGAL, India

Dr Suhina Roy Chowdhury

Principal investigator

8420398205

suhinaroychowdhury@gmail.com