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Clinical Trials/CTRI/2025/09/094331
CTRI/2025/09/094331
Not yet recruiting
Phase 4

Evaluation Of Postoperative Pain Following Single - Visit Root Canal Treatment With Protaper Gold and Wave One Gold File System In Controlled Diabetic Patients With Irreversible Pulpitis: An In-Vivo Study

Dr Shubha V Samorekar1 site in 1 country48 target enrollmentStarted: September 20, 2025Last updated:

Overview

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Dr Shubha V Samorekar
Enrollment
48
Locations
1
Primary Endpoint
Post-operative pain intensity measured using visual analog scale to evaluate post operative tooth pain

Overview

Brief Summary

This study aims to compare post-operative tooth pain after root canal treatment using two different endodontic file system - ProTaper Gold rotary file system and WaveOne Gold reciprocating file system in patients with controlled diabetes mellitus.

Root canal therapy is commonly associated with post-operative pain, and this pain may vary depending on the instrumentation technique used.

The study will evaluate post-operative pain intensity using a Visual Analogue Scale (VAS) at specific time intervals after the procedure (6 hours, 24 hours, 48 hours, 72 hours, and 7 days).

Findings from this study may help in selecting the appropriate root canal technique to minimize pain in diabetic patients.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
28.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients with Type 2 Diabetes mellitus for a minimum of 5 years and who are under medication with HbA1c under 7 Teeth with irreversible pulpitis.

Exclusion Criteria

  • Patients with complicated systemic diseases under medication for the same.
  • Patients who took medication for pain relief within 48 h before the start of treatment.
  • Patients having severe pain and/or apical abscess.
  • Patients having multiple teeth requiring treatment.
  • Patients with non restorable periodontally compromised teeth Pregnant patients.
  • Teeth with calcified canals.

Outcomes

Primary Outcomes

Post-operative pain intensity measured using visual analog scale to evaluate post operative tooth pain

Time Frame: Pain will be assessed at 6 hours, 12 hours, 24 hours, 48 hours, 72 hours and 7 days after treatment

Secondary Outcomes

  • Incidence of Procedural Complications and Analgesic Consumption

Investigators

Sponsor
Dr Shubha V Samorekar
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Shubha V Samorekar

Surendera dental college and research institute

Study Sites (1)

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