The Effect of Photobiomodulation Using Low-Level Diode Laser Therapy on Postoperative Pain in Symptomatic Lower Molar Teeth With Irreversible Pulpitis and Apical Periodontitis; a Randomized Controlled Clinical Trial

April 29, 2024 updated by: Nour ElGendi, Cairo University
this study aims to assess the effect of photobiomodulation using low-level diode laser therapy on postoperative pain after single-visit root canal treatment of mandibular molars with symptomatic irreversible pulpitis and apical periodontitis.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • . Mature multirooted mandibular molar teeth with: i. Pre-operative sharp pain marked on the VAS scale by reading not less than 6. ii. Clinical diagnosis of symptomatic irreversible pulpitis with periapical periodontitis.

iii. Normal periapical radiographic appearance or slight widening in lamina dura. iv. Positive response and pain provoked by percussion.

- Patients who agree to provide written consent and attend for recall appointments.

Exclusion Criteria:

  • Patients who used NSAIDs in the 24 hours before treatment.
  • Medically compromised patients having significant systemic disorders. (ASA III or IV).
  • Patients with two or more adjacent teeth requiring endodontic treatment.

  • Pregnant or nursing females. 5. Teeth that have:

    i. Periodontal affection (with pocket depth greater than 5mm, associated with swelling orfistulous tract, or greater than grade I mobility).

ii. No possible restorability. iii. Signs of pulpal necrosis; associated sinus tract or swelling.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Photobiomodulation using diode laser
Irradiation of periapical tissues with low level diode laser therapy buccally and lingually
Device: Photobiomodulation by low level diode laser
Diode laser exposure (Lite Medics 1.00-Watt serial number 148 Ver. SwvM. 150VS108VT.100) will be carried out using a continuous mode with 10 Hz frequency, 980 nm wavelength, and max power 15 WCW. The tip will be applied both at the buccal and the lingual side for 30 s each.
Placebo Comparator: Placebo/ Mock Laser
Application of laser probe without device activation
Other: Mock Laser Application
Placebo for control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intensity of postoperative pain
Time Frame: 24, 48 and 72 hours
Using modified VAS
24, 48 and 72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total number of analgesic tablets taken in case of intolerable pain
Time Frame: Post instrumentation at 24, 48 and 72 hours
Counted and recorded by the patient on a special table.
Post instrumentation at 24, 48 and 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 20, 2024

Primary Completion (Estimated)

April 20, 2025

Study Completion (Estimated)

May 29, 2025

Study Registration Dates

First Submitted

April 29, 2024

First Submitted That Met QC Criteria

April 29, 2024

First Posted (Estimated)

May 2, 2024

Study Record Updates

Last Update Posted (Estimated)

May 2, 2024

Last Update Submitted That Met QC Criteria

April 29, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENDO 3-3-5 (29/4/24)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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