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

NCT04486196 | Completed

• 1 other identifier: BİRUNİ-BAP-01-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Apical Periodontitis; Postoperative Pain

Keywords

diode laser; irrigation; post-operative pain; root canal treatment; visual analog scale

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Analgesic intake

  7 days

Study Arms (2)

Control (No Laser) Group

EXPERIMENTAL

The final irrigation was performed using 5ml 2.5% NaOCI, followed by 5 ml 17% EDTA for 3 min and 5 ml distilled water.

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

Laser Disinfection (LD) Group

EXPERIMENTAL

After final irrigation was performed using 5ml 2.5% NaOCI, followed by 5 ml 17% EDTA for 3 min and 5 ml distilled water, 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. This cycle was applied 4 times for each root canal. The optical fiber (Medency) was inserted 1 mm short of the apex and the root canals were slowly (at a speed of 2mm/s) irradiated from apical to coronal in continuous circling movements to treat all dentinal tubules in one cycle for each power.

Device: Medency Primo Diode Laser Device (Medency, Vicenza, Italy)

Interventions

Medency Primo Diode Laser Device (Medency, Vicenza, Italy) DEVICE

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.

Laser Disinfection (LD) Group

2.5% NaOCl, %17 EDTA, Distilled water, 30-gauge, side-opening needle (Canal Clean, Biodent, South Korea), PROCEDURE

Final conventional irrigation

Control (No Laser) Group

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biruni University: lead

Study Sites (1)

Biruni University

Istanbul, 34010, Turkey (Türkiye)

Location

Related Publications (1)

• Kaplan T, Sezgin GP, Sonmez Kaplan S. Effect of a 980-nm diode laser on post-operative pain after endodontic treatment in teeth with apical periodontitis: a randomized clinical trial. BMC Oral Health. 2021 Jan 22;21(1):41. doi: 10.1186/s12903-021-01401-w.

  PMID: 33482797 DERIVED

MeSH Terms

Conditions

Periapical Periodontitis; Pain, Postoperative

Interventions

Biodent

Condition Hierarchy (Ancestors)

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

Study Officials

• Sema Sönmez Kaplan, DDS, PhD

  Biruni University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 24, 2020
• Study Start: April 8, 2019
• Primary Completion: November 2, 2019
• Study Completion: November 20, 2019
• Last Updated: July 24, 2020

Record last verified: 2020-07

Locations

TU (1)