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NCT Number: NCT04486196

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

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).

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Biruni University

Istanbul, 34010, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Procedure

Final conventional irrigation

Primary outcomes

  1. Post-operative pain

    Time frame: 7 days

    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.

Secondary outcomes

  1. Analgesic intake

    Time frame: 7 days

    After first and second appointments, analgesic use and time intervals will be recorded.

Sponsors and collaborators

Lead sponsor

Biruni University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 24, 2020
Registry last updated
Jul 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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