Comparison of postoperative pain intensity after using different systems in symptomatic patients

Completed

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

• Registration Number: CTRI/2021/06/034295
• Lead Sponsor: SGT University

Brief Summary

175 Patients presenting with symptomatic irreversible pulpitis will be selected on the basis of inclusion & exclusion criteria for the study.Randomisation will be done using coloured tokens and patients will be divided into 5 groups namely : manual glide path group, R – Motion Glider Group (reciprocating), Wave One Gold Glider Group (reciprocating), TruNatomy Glider Group (rotary) & Hyflex EDM Glider Group (rotary). Treatment plan will be explained to the subjects and an informed consent will be taken. Local anaesthesia will be given, proper rubber dam isolation will be done prior to commencement of procedure. In the manual glide path group, glide path  will be created using stainless steel k files and working length will be recorded. In all the mechanical glide path groups, stainless steel k files will be used to measure Working Length. The files will be used according to manufacturer’s instructions till defined working length. After glide path creation, subsequent endodontic procedures including chemomechanical preparation and obturation will be standardized for all five groups Complete Root Canal Procedure would be completed in the same sitting. TruNatomy File System (Dentsply) will be used to prepare the root canals During instrumentation, irrigation will be done thoroughly in all the groups. A standard irrigation protocol will be followed for all the groups. Irrigation will be  performed with a TruNatomy 30-gauge double side vent needle. Master cone will be checked by taking radiograph , after that obturation will be done in the same sitting followed by restoration, Complete treatment will be done by a single operator in a single sitting. Patients will be given post operative instructions, a prescription for optional analgesics & a HP VAS scale form which needs to be filled by patient at : 6hrs,12hrs,24hrs,48hrs,72hrs & 1 week post treatment. Patients will also be instructed to keep a record of analgesic intake.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-21
• Study Completion: 2022-12-30
• Last Update Posted: 2023-08-01

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

Teeth with symptomatic irreversible pulpitis in systemically healthy patients Positive response to vitality tests and a history of pain and presenting symptoms characteristic of symptomatic irreversible pulpitis Patients with Moderate to Severe pain according to HP VAS Scale.

Exclusion Criteria

Patients with a diagnosis of asymptomatic irreversible pulpitis Patients having pulp necrosis, sinus tract, periapical abscess, or facial cellulitis Patients having a negative response to pulp vitality tests Teeth with inadequate tooth structure or poor periodontal status.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain	6hrs,12hrs,24hrs

Secondary Outcome Measures

Name	Time	Method
Pain	48hrs, 72hrs & 1 week

Trial Locations

Locations (1)

SGT University; 🇮🇳 Gurgaon, HARYANA, India

SGT University

🇮🇳Gurgaon, HARYANA, India

Tarshit Malik

Principal investigator

9728580999

drmalik25tarshit@gmail.com