Effect of Passive Ultrasonic Irrigation Activation Cycle on Postoperative Pain

NCT06711029 | Not Yet Recruiting

• 1 other identifier: 03/15.11.2023
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

One of the most important goals of root canal treatment is to eliminate bacteria from infected canals. However, conventional irrigation methods combined with mechanical preparation applied during root canal treatment may not be sufficient for optimal disinfection. Various studies have shown that there are areas in the root canal that cannot be reached during chemomechanical shaping. One of the most popular techniques developed to deliver irrigation solutions to these areas is the Passive Ultrasonic Irrigation (PUI) technique, which provides good efficiency in terms of cleaning the root canal system. Activation of NAOCI with ultrasonic systems in the final irrigation significantly reduces the amount of microorganisms in the canal. Although the use of PUI in the final irrigation increases the effectiveness of irrigation solutions and enables the solutions to reach the apical third of the root canal, it causes extrusion of solutions into periapical tissues, albeit in small amounts, due to the positive apical pressure it creates during irrigation, and this causes postoperative pain. Postoperative pain is an undesirable but frequently encountered condition after endodontic treatment. During root canal treatment, extrusion of irrigation solutions or debris from the apex, mechanical, chemical or microbial factors can cause postoperative pain. In one study, the incidence of postoperative pain after endodontic treatment was reported to vary from 3% to 58%. Although the most effective is not yet fully known, when the literature is reviewed, different durations and cycles have been used for PUI. The change in the number of PUI cycles increases the microflow in the root canal, which may increase irrigation extrusion from the apical region and affect postoperative pain. Although many results have been reported in studies comparing the effect of final activation with Passive Ultrasonic Irrigation on postoperative pain with another technique, the activation cycle with PUI was determined as 3 times and 20 seconds each time, and this cycle order remained the same most of the time. Since there is no study in which the differences between cycles in activation with PUI affected postoperative pain, in this study the irrigation solution will be activated with PUI 3 times for 20 seconds and 6 times for 10 seconds, and the postoperative pain created by these two cycle orders will be compared.

Conditions

Postoperative Pain

Keywords

Postoperative Pain; Passive ultrasonic irrigation; Activation cycles

Outcome Measures

Primary Outcomes (1)

• Visual Analog Score Scala

  Postoperative pain will be assessed with a visual analog score after endodontic treatment. Scores will be given between 0-10. A score of '0' means no pain, a score of '10' means very severe pain. The higher the score, the higher the pain level.

  The change in the postoperative pain levels by the patient at the 6 hours, 12 hours, 24 hours, 48 hours, 72 hours and at the end of 1 week will be compared.

Study Arms (3)

Control Group

ACTIVE COMPARATOR

In the final irrigation, 6 ml of 5.252% NaOCI will be applied with needle irrigation for a total of 60 seconds.

Other: Conventional needle irrigation

Passive Ultrasonic Irrigation 3*20 sec

ACTIVE COMPARATOR

In the final irrigation, 6 ml of 5.25% NaOCI will be applied as 3\*20 seconds with PUI for a total of 60 seconds.

Other: Passive Ultrasonic Irrigation with 3*20 sn

Passive Ultrasonic Irrigation 6*10 sec

ACTIVE COMPARATOR

In the final irrigation, 6 ml of 5.25% NaOCI will be applied as 6\*10 seconds with PUI for a total of 60 seconds.

Other: Passive Ultrasonic Irrigation with 6*10 sn

Interventions

Conventional needle irrigation OTHER

Conventional needle irrigation method was applied. As a final irrigation, 6 ml NaOCl was applied with 60 seconds of needle irrigation followed by 60 seconds of rest.

Control Group

Passive Ultrasonic Irrigation with 3*20 sn OTHER

In the final irrigation, 6 ml (3×2 ml) NaOCl was activated by PUI for 20 seconds in 3 cycles (60 seconds total). Before each cycle, 2 ml of NaOCl solution was refreshment.

Passive Ultrasonic Irrigation 3*20 sec

Passive Ultrasonic Irrigation with 6*10 sn OTHER

For the final irrigation, 6 ml (6×1 ml) NaOCl was activated with PUI for 10 seconds in 6 cycles (60 seconds total). Before each cycle, 1 ml of NaOCl solution was refreshment.

Passive Ultrasonic Irrigation 6*10 sec

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy persons between the ages of 18 and 45 years
• Single-rooted and single-canal mandibular premolars diagnosed with symptomatic irreversible pulpitis

You may not qualify if:

• Patients who are taken analgesic inflammatory drugs with in the last 12 hours
• Pregnancy or lactation
• Teeth with calcified canals
• Teeth with sensitive to percussion and palpation
• Teeth with root resorption
• Teeth with immature/open apex

Sponsors & Collaborators

• Esin Özlek: lead
• Yuzuncu Yil University: collaborator

Related Publications (4)

• Topcuoglu HS, Topcuoglu G, Arslan H. The Effect of Apical Positive and Negative Pressure Irrigation Methods on Postoperative Pain in Mandibular Molar Teeth with Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial. J Endod. 2018 Aug;44(8):1210-1215. doi: 10.1016/j.joen.2018.04.019. Epub 2018 Jun 20.

  PMID: 29935873 BACKGROUND

• Estevez R, Conde AJ, Valencia de Pablo O, de la Torre F, Rossi-Fedele G, Cisneros R. Effect of Passive Ultrasonic Activation on Organic Tissue Dissolution from Simulated Grooves in Root Canals Using Sodium Hypochlorite with or without Surfactants and EDTA. J Endod. 2017 Jul;43(7):1161-1165. doi: 10.1016/j.joen.2017.01.041. Epub 2017 Apr 14.

  PMID: 28416316 BACKGROUND

• Middha M, Sangwan P, Tewari S, Duhan J. Effect of continuous ultrasonic irrigation on postoperative pain in mandibular molars with nonvital pulps: a randomized clinical trial. Int Endod J. 2017 Jun;50(6):522-530. doi: 10.1111/iej.12666. Epub 2016 Jun 28.

  PMID: 27248848 BACKGROUND

• Ali A, Hashem AAR, Roshdy NN, Abdelwahed A. The Effect of Final Irrigation Agitation Techniques on Postoperative Pain after Single Visit Root Canal Treatment of Symptomatic Irreversible Pulpitis: A Randomised Clinical Trial. Eur Endod J. 2023 May;8(3):187-193. doi: 10.14744/eej.2022.39200.

  PMID: 37257031 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Hüseyin Gündüz

CONTACT

+905413523162; gunduzdt@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Model Details: Patients will be divided into 3 groups according to the final irrigation activation method; Group 1: Control Group, Group 2: Passive Ultrasonic Irrigation 3\*20 sec, Group 3: Passive Ultrasonic Irrigation 6\*10 sec.

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: December 2, 2024
• Study Start: December 1, 2024
• Primary Completion: February 10, 2025
• Study Completion: March 10, 2025
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share