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NCT05032612 Clinical Trial

Effects of Photobiomodulation on Postoperative Pain After Primary Endodontic Therapy in Molars With Symptomatic Apical Periodontitis

Postoperative Pain Clinical Trial

Official title:
Effects of Photobiomodulation on Postoperative Pain After Primary Endodontic Therapy in Molars With Symptomatic Apical Periodontitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05032612
Other study ID # HSC-DB-21-0579
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 16, 2021
Est. completion date March 16, 2022

Study information
Verified date March 2023
Source The University of Texas Health Science Center, Houston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effects of photobiomodulation (PBM) on postoperative pain after endodontic treatment in mandibular molar teeth diagnosed with symptomatic apical periodontitis.

Recruitment information / eligibility
Status Completed
Enrollment 32
Est. completion date March 16, 2022
Est. primary completion date March 16, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Posterior mandibular molars - No previous root canal therapy on the tooth in question - Able to complete the endodontic treatment in one visit Exclusion Criteria: - Maxillary teeth, mandibular anteriors and premolars - Infection (swelling, sinus tract) on the tooth in question - Periodontal disease on the tooth in question - Dental trauma - Crown/ root fractures - Systemic diseases - Immunocompromised patients

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• PBM Therapy
After the endodontic treatment, PBM therapy will be performed using a 660 nm diode laser (SiroLaser Advance Plus, Dentsply Sirona Inc, Charlotte, NC, USA), with an 8mm tip diameter.The laser tip will be placed on the following external surfaces in a contact mode: mesiobuccal, distobuccal, mesiolingual and distolingual . The power output of the laser will be 50mW and will be verified by Power Meter (PM600 Power/Energy meter, Molectron Detector Inc, Portland, OR, USA). Each site will be irradiated for 25 s with an energy density of 10 J/cm2 .
• PBM Sham
For the PBM sham similar procedure as PBM therapy will be performed without activating the laser.

Locations
Country Name City State
United States The University of Texas Health Science Center at Houston Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain as Assessed by the Visual Analog Scale This scale ranges form 0(no pain) to 10(worst pain) 72 hours after treatment
Secondary Pain as Assessed by the Visual Analog Scale This scale ranges form 0(no pain) to 10(worst pain) 0 hours, 6 hours, 12 hours and 24 hours hours after treatment
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