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

NCT05195021 | Completed

• 1 other identifier: BİRUNİ-BAP-2020-01-47
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Post-operative Pain; Apical Periodontitis

Keywords

diode laser; EDDY; post-operative pain; sypmtomatic apical periodontitis

Outcome Measures

Primary Outcomes (2)

• 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

• Anaglesic intake

  After the operation nalgesic intake and time intervals were recorded

  7 days

Study Arms (4)

Group 1 (conventional irrigation)

EXPERIMENTAL

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.

Device: Conventional irrigation

Group 2 (EDDY)

EXPERIMENTAL

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.

Device: EDDY; Device: Conventional irrigation

Group 3 (conventional irrigation and laser irradiation)

EXPERIMENTAL

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.

Device: Diode Laser device; Device: Conventional irrigation

Group 4 (EDDY and laser irradiation)

EXPERIMENTAL

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.

Device: EDDY; Device: Diode Laser device; Device: Conventional irrigation

Interventions

EDDY DEVICE

EDDY (VDW) sonic irrigation activation system

Also known as: EDDY (VDW, Munich, Germany)

Group 2 (EDDY); Group 4 (EDDY and laser irradiation)

Diode Laser device DEVICE

980-nm diode laser device

Also known as: Medency Primo 10 W Diode Laser, Vicenza, Italy

Group 3 (conventional irrigation and laser irradiation); Group 4 (EDDY and laser irradiation)

Conventional irrigation DEVICE

Conventional root canal irrigation with 31-guage side port needle

Also known as: 31-guage side port needle (NaviTip; Ultradent, South Jordan, UT)

Group 1 (conventional irrigation); Group 2 (EDDY); Group 3 (conventional irrigation and laser irradiation); Group 4 (EDDY and laser irradiation)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult patients aged between 18 and 65 years
• Moderate to severe pain (4-10) according to a visual analogue scale (VAS)
• Mandibular molar teeth diagnosed with symptomatic apical periodontitis (a painful response during mastication and/or percussion or palpation)

You may not qualify if:

• Pregnancy or lactation
• Taking analgesics or anti-inflammatory drugs 12 hours before the treatment
• Taking antibiotics in the month prior to the treatment
• 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
• Allergy to articaine or non-steroid anti-inflammatory drugs

Sponsors & Collaborators

• Biruni University: lead

Study Sites (1)

Biruni University

Istanbul, 34010, Turkey (Türkiye)

Location

Related Publications (1)

• Kaplan T, Kaplan SS, Sezgin GP. The effect of different irrigation and disinfection methods on post-operative pain in mandibular molars: a randomised clinical trial. BMC Oral Health. 2022 Dec 13;22(1):601. doi: 10.1186/s12903-022-02651-y.

  PMID: 36514017 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Periapical Periodontitis

Interventions

Lasers, Semiconductor

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Sema Sönmez Kaplan, DDS, PhD

  Biruni University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 18, 2022
• Study Start: December 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: July 30, 2021
• Last Updated: January 18, 2022

Record last verified: 2022-01

Locations

TU (1)