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Clinical Trials/CTRI/2022/09/045537
CTRI/2022/09/045537CompletedPhase 4

Comparative Evaluation of Three Irrigation Techniques on Causing Post OperativePain in Single Rooted Teeth with Symptomatic Irreversible Pulpitis orApical Periodontitis : A Randomized Controlled Trial

All India Institute of Medical Sciences1 site in 1 country48 target enrollmentStarted: September 19, 2022Last updated:

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
48
Locations
1
Primary Endpoint
To comparatively evaluate the incidence and intensity of post-operative pain using positive pressure, negative pressure and sonic activated irrigation following single visit root canal therapy.

Study Overview

Brief Summary

Chemo-mechanical debridement of the root canal aims to remove pulpal tissues, microorganisms and their by-products, and debris using endodontic instruments and irrigants. Endodontic irrigant reduces the friction between the instrument and dentin; improves the cutting effectiveness of the files used; dissolves tissue; cools the file and tooth; and, furthermore, it has both a washing effect and an antimicrobial/antibiofilm effect. Irrigants have traditionally been delivered into the root canal space using syringes and metal needles of different sizes and tip designs. Many irrigation devices have been developed with the aim of improving the irrigant delivery throughout the root canal by using ultrasonic or sonic energy and apical negative pressure. One of the important aspects of root canal therapy is to control pain after treatment. Postoperative pain is an unwanted yet unfortunately common sensation after endodontic treatment. The incidence of postoperative pain was reported to range from 3% to 58%. There is no single factor affecting pain after root canal treatment and it may be due to mechanical, chemical and/or microbial injury to the pulp or periradicular tissues. Irrigating solutions or medications can evoke pain by irritating the periradicular tissues. The root canal irrigation method could affect the amount of apically extruded debris or irrigants. Any irrigation delivery system that reduces the risk of extrusion into periapical tissues would help the patient and the clinician because such a system could decrease postoperative discomfort.

Thus, the present clinical trial aims to comparatively evaluate the three irrigation techniques on causing post operative pain in symptomatic irreversible pulpitis/ apical periodontitis following single visit root canal therapy.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

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

Inclusion Criteria

  • 1.Healthy persons(ASA I) between the age group of 16 years to 65 years 2.Single rooted teeth diagnosed with symptomatic irreversible pulpitis and apical periodontitis 3.Patients with preoperative pain score ranging from moderate to severe (45–100 mm) on a visual analog scale (VAS, 0–100 mm).

Exclusion Criteria

  • 1.Patients who had taken analgesic or anti-inflammatory drugs within the last 12 hours 2.Pregnancy or lactation 3.Teeth with calcified canals 4.Teeth with periodontal diseases 5.Teeth with root resorption 6.Teeth with immature/open apex 7.Previously treated or initiated tooth.

Outcomes

Primary Outcomes

To comparatively evaluate the incidence and intensity of post-operative pain using positive pressure, negative pressure and sonic activated irrigation following single visit root canal therapy.

Time Frame: 6, 24, 48, and 72 hours after treatment

Secondary Outcomes

  • To comparatively evaluate the positive pressure, negative pressure irrigation technique and sonic activated irrigation on requirement/prescription of analgesics for post-operative pain following single visit root canal therapy.(6, 24, 48, and 72 hours after treatment)

Investigators

Sponsor Class
Government medical college

Study Sites (1)

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