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

Not Applicable

Completed

• Conditions: Post-operative Pain; Apical Periodontitis
• Interventions: Device: EDDY; Device: Conventional irrigation; Device: Diode Laser device

• Registration Number: NCT05195021
• Lead Sponsor: Biruni University

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-01
• Primary Completion: 2021-06-30
• Study Completion: 2021-07-30
• Status Verified: 2022-01
• Study First Submitted: 2022-01-04
• Study First Submitted QC: 2022-01-04
• Last Update Submitted: 2022-01-04
• Study First Posted: 2022-01-18
• Last Update Posted: 2022-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2 (EDDY)	Conventional irrigation	In group 2, 1 ml of 5.25% NaOCl was agitated for 20 seconds three times with the EDDY tip positioned 2 mm shorter than the WL. The root canals were then irrigated with 2 ml of 5.25% NaOCl again. Subsequently, the EDDY tip was activated with short pumping movements, and 2 ml of 17% EDTA was activated for 30 seconds, as described above. The final irrigation followed the same procedures as in group 1.
Group 4 (EDDY and laser irradiation)	EDDY	In this group, after agitation using the EDDY (VDW) system was performed using the same procedures as in group 3, final irrigation and laser irradiation were done as in group 2.
Group 4 (EDDY and laser irradiation)	Diode Laser device	In this group, after agitation using the EDDY (VDW) system was performed using the same procedures as in group 3, final irrigation and laser irradiation were done as in group 2.
Group 3 (conventional irrigation and laser irradiation)	Conventional irrigation	In group 3, final irrigation followed the same procedures as in group 1 and group 2. During the laser therapy, both the operator and the patient wore eyewear for protection. Laser irradiation was performed using a 980-nm diode laser (Medency Primo 10 W Diode Laser; Vicenza, Italy), coupled with optical fibre (200 µm). The settings were as follows: average power of 1.2 W with a low frequency of 50 Hz and energy of 12 J (each cycle) in pulsed mode, irradiation for 10 seconds, followed by a 10 second pause, which constituted one cycle. This cycle was applied four times to each root canal. The optical fibre tip was located at the WL. The root canals were then slowly (at a speed of 2 mm/s) irradiated from the apical to the coronal portion using a continuous helicoidal movement, with optical fibre tip contacting the root canal walls in one cycle for each power.
Group 3 (conventional irrigation and laser irradiation)	Diode Laser device	In group 3, final irrigation followed the same procedures as in group 1 and group 2. During the laser therapy, both the operator and the patient wore eyewear for protection. Laser irradiation was performed using a 980-nm diode laser (Medency Primo 10 W Diode Laser; Vicenza, Italy), coupled with optical fibre (200 µm). The settings were as follows: average power of 1.2 W with a low frequency of 50 Hz and energy of 12 J (each cycle) in pulsed mode, irradiation for 10 seconds, followed by a 10 second pause, which constituted one cycle. This cycle was applied four times to each root canal. The optical fibre tip was located at the WL. The root canals were then slowly (at a speed of 2 mm/s) irradiated from the apical to the coronal portion using a continuous helicoidal movement, with optical fibre tip contacting the root canal walls in one cycle for each power.
Group 1 (conventional irrigation)	Conventional irrigation	After finishing the mechanical instrumentation, each root canal was irrigated with 5 ml of 5.25% NaOCl using a 31-gauge needle positioned 2 mm shorter than the WL. To remove the smear layer, 5 ml of 17% ethylenediaminetetraacetic acid (EDTA) was used in each canal for 1 minute, and 5 ml of saline was then administered to neutralize all the residues.
Group 2 (EDDY)	EDDY	In group 2, 1 ml of 5.25% NaOCl was agitated for 20 seconds three times with the EDDY tip positioned 2 mm shorter than the WL. The root canals were then irrigated with 2 ml of 5.25% NaOCl again. Subsequently, the EDDY tip was activated with short pumping movements, and 2 ml of 17% EDTA was activated for 30 seconds, as described above. The final irrigation followed the same procedures as in group 1.
Group 4 (EDDY and laser irradiation)	Conventional irrigation	In this group, after agitation using the EDDY (VDW) system was performed using the same procedures as in group 3, final irrigation and laser irradiation were done as in group 2.

Primary Outcome Measures

Name	Time	Method
Post-operative pain	7 days	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
Anaglesic intake	7 days	After the operation nalgesic intake and time intervals were recorded

Trial Locations

Locations (1)

Biruni University; 🇹🇷 İstanbul, Turkey