The Effect of Different Irrigation and Disinfection Methods on Post-operative Pain (PP)

Post-operative Pain Clinical Trial

— PP  

Official title:

The Effect of Different Irrigation and Disinfection Methods on Post-operative Pain in Mandibular Molars With Symptomatic Apical Periodontitis: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05195021
• Other study ID #: BIRUNI-BAP-2020-01-47
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: January 2022
• Source: Biruni University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aim: The aim of this study was to examine post-operative pain (PP) severity after conventional irrigation and sonic activation methods, with and without laser disinfection in mandibular molar teeth diagnosed with symptomatic apical periodontitis.

Methods: In total, 80 patients with symptomatic apical periodontitis were included in this randomized clinical study. There were four different irrigation and disinfection groups. In group 1, conventional irrigation only was applied. In group 2, EDDY (VDW, Munich, Germany), a sonic irrigation activation system, was applied. In groups 3 and 4, irradiation with a 980-nm diode laser was performed, following irrigation with the conventional method (needle irrigation) and EDDY (VDW) irrigation system, respectively. PP was assessed using a visual analogue scale (VAS). The patients were instructed to record their PP using this scale 8, 24, 48 hours and 7 days post-procedure, in addition to their analgesic intake. A chi-square test, Fisher's exact chi-square test and Fisher-Freeman-Halton exact test were used to assess qualitative data. Inter-group and intra-group parameters were assessed using the Kruskal-Wallis test and Wilcoxon's test at a significance level of p < 0.05 (for both).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Healthy adult patients aged between 18 and 65 years

2. Moderate to severe pain (4-10) according to a visual analogue scale (VAS)

3. Mandibular molar teeth diagnosed with symptomatic apical periodontitis (a painful response during mastication and/or percussion or palpation)

Exclusion Criteria:

1. Pregnancy or lactation

2. Taking analgesics or anti-inflammatory drugs 12 hours before the treatment

3. Taking antibiotics in the month prior to the treatment

4. Teeth with calcified root canals, greater than grade I mobility and a 4 mm pocket depth, non-restorable damage, occlusal trauma and previous root canal treatment or an open apex

5. Allergy to articaine or non-steroid anti-inflammatory drugs

Related Conditions & MeSH terms

• Apical Periodontitis
• Pain, Postoperative
• Periapical Periodontitis
• Periodontitis
• Post-operative Pain

Intervention

Device:
• EDDY
EDDY (VDW) sonic irrigation activation system
• Diode Laser device
980-nm diode laser device
• Conventional irrigation
Conventional root canal irrigation with 31-guage side port needle

Locations

Country	Name	City	State
Turkey	Biruni University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Biruni University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative pain	Post-operative pain levels in each group were assessed by visual analog scale (VAS) The pain levels were evaluated at 8, 24, 48 hours and 7 days post-procedure	7 days
Primary	Anaglesic intake	After the operation nalgesic intake and time intervals were recorded	7 days