Effect of Diode Laser on Post-operative Pain After Endodontic Treatment in Teeth With Apical Periodontitis

Postoperative Pain Clinical Trial

Official title:

Effect of Root Canal Disinfection With 980 µm Diode Laser on Post-operative Pain After Endodontic Treatment in Teeth With Apical Periodontitis: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04486196
• Other study ID #: BIRUNI-BAP-01-01
• Status: Completed
• Phase: N/A
• Start date: April 8, 2019
• Est. completion date: November 20, 2019

Study information

• Verified date: July 2020
• Source: Biruni University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aim: This study aims to assess the effect of root canal disinfection with a 980 µm diode laser following chemomechanical root canal preparation on the severity of pain after root canal treatment (RCT).

Materials and Methods: In present study, asymptomatic, single-rooted teeth with periapical index (PAI) score 3 or 4 were included. All patients were treated with two visits of root canal treatment including dressing with calcium hydroxide. Patients were randomly divided into two groups (n: 28). 'Control (no laser)': The final irrigation was performed using 5ml 2.5% NaOCI, followed by 5 ml 17% EDTA and 5 ml distilled water. 'Laser Disinfection (LD)': Root canals were irradiated with 980 µm diode laser after final irrigation at both visits. The pain levels were evaluated using visual analog scale (VAS) after 8, 24, 48 hours and 7 days. In addition, analgesic intake and time intervals were recorded by patients. The collected data were statistically analyzed with the Chi-square and Mann-Whitney U test (p<0.05).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 20, 2019
• Est. primary completion date: November 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy patients

• Patients that had asymptomatic, single-rooted teeth with PAI score 3 or 4

Exclusion Criteria:

• antibiotic use with in the last month,

• anti-inflammatory analgesic use within the last five days,

• systemic disorder, pregnancy or lactation,

• traumatic occlusion,

• presence of other teeth requiring RCT,

• teeth with root canal fillings,

• calcified canals,

• root resorption,

• periodontal diseases,

• sinus tracts

• severe crown destruction preventing rubber-dam application

Related Conditions & MeSH terms

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

Intervention

Device:
• Medency Primo Diode Laser Device (Medency, Vicenza, Italy)
Root canals were irradiated with 980 nm diode laser coupled with optical fiber 200 µm with setting at the average power 1.2-W in pulsed mode. 10 seconds irradiation followed by 10 seconds pause, which comprised one lasting cycle.

Procedure:
• 2.5% NaOCl, %17 EDTA, Distilled water, 30-gauge, side-opening needle (Canal Clean, Biodent, South Korea),
Final conventional irrigation

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 will be assessed by visual analog scale (VAS).The pain levels will be evaluated after 8, 24, 48 hours and 7 days.	7 days
Secondary	Analgesic intake	After first and second appointments, analgesic use and time intervals will be recorded.	7 days