Effect of Passive Ultrasonic Irrigation Versus Needle Irrigation on Postoperative Pain and Periapical Healing

Apical Periodontitis Clinical Trial

Official title:

Comparison of Postoperative Pain and Healing After Passive Ultrasonic Irrigation and Needle Irrigation in Patients With Apical Periodontitis: A Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02913937
• Other study ID #: CEBD-CU-2016-09-201
• Status: Not yet recruiting
• Phase: N/A
• First received: September 22, 2016
• Last updated: February 7, 2017
• Start date: February 2017
• Est. completion date: January 2019

Study information

• Verified date: October 2016
• Source: Cairo University
• Contact: Noha aly, Postgraduate
• Phone: 01015011128
• Email: nohatawfik26[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare the effect of passive ultrasonic irrigation versus needle irrigation on post-operative pain and healing in patients with permanent posterior teeth with apical periodontitis treated in a single visit.

Description:

Full medical and dental history using a dental chart for all patients treated in this study.

Clinical and radiographic examination will be done for all patients to verify the diagnosis of apical periodontitis with periapical radiolucency at least 2mm in diameter.

The treatment protocol and its associated risks and benefits will be explained to the eligible patients before obtaining informed consent. Endodontic procedures will be done in a single visit as follows: access cavity preparation using sterile round bur and Endo-Z bur, isolation using a rubber dam, canal preparation using a nickel-titanium rotary system then obturation. During mechanical preparation, irrigation will be done using passive ultrasonic irrigation (Experimental group) where ultrasonic activation will be done for irrigant-filled canals using the U- file tip (Varios NSK) in an ultrasonic device (P5 Newtron; Satelec Acteon) 1mm from the working length after each file change for 10 sec, or needle irrigation (Control group) where only the endodontic irrigation needle will be used; the irrigation protocol for each patient will be determined following a random-number sequence.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: January 2019
• Est. primary completion date: February 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Age between 18-55 years old.

• Males and females.

• Positive patient's acceptance to participate in the study.

• Mature, permanent, mandibular, posterior teeth with apical periodontitis.

Exclusion Criteria:

• Medically compromised patients so that no other pain source or drug interaction could interfere with pain resulting from the endodontic therapy.

• Patients who had received analgesic treatment recently (past 8 hours) as it can affect the results

• Pregnant females.

• Teeth with previous root canal treatment.

Related Conditions & MeSH terms

• Apical Periodontitis
• Pain, Postoperative
• Periapical Periodontitis
• Periodontitis

Intervention

Device:
• Passive ultrasonic irrigation
Endodontic irrigation followed by passive ultrasonic agitation.
• Endodontic needle
Endodontic irrigation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (2)

Gondim E Jr, Setzer FC, Dos Carmo CB, Kim S. Postoperative pain after the application of two different irrigation devices in a prospective randomized clinical trial. J Endod. 2010 Aug;36(8):1295-301. doi: 10.1016/j.joen.2010.04.012. — View Citation

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. 2016 Jun 1. doi: 10.1111/iej.12666. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain	postoperative pain will be assessed using numerical rate scale (NRS).	7 days
Secondary	Periapical healing	Periapical healing will be assessed using periapical index (PAI).	12 months