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

Sponsor
The University of Texas Health Science Center, Houston (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05032612
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
7
Anticipated Duration (Months)
5.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: PBM Therapy
  • Device: PBM Sham
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
Effects of Photobiomodulation on Postoperative Pain After Primary Endodontic Therapy in Molars With Symptomatic Apical Periodontitis
Anticipated Study Start Date :
Sep 15, 2021
Anticipated Primary Completion Date :
Jan 15, 2022
Anticipated Study Completion Date :
Apr 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: PBM Therapy

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 .
Sham Comparator: PBM Sham

Device: PBM Sham
For the PBM sham similar procedure as PBM therapy will be performed without activating the laser.

Outcome Measures

Primary Outcome Measures

  1. Pain as assessed by the visual analog scale [72 hours after treatment]

    This scale ranges form 0(no pain) to 10(worst pain)

Secondary Outcome Measures

  1. Change in pain as assessed by the visual analog scale [6 hours, 12 hours and 24 hours hours after treatment]

    This scale ranges form 0(no pain) to 10(worst pain)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Texas Health Science Center at Houston Houston Texas United States 77030

Sponsors and Collaborators

  • The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Ryne Jackson, DMD, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ryne Jackson, Student, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT05032612
Other Study ID Numbers:
  • HSC-DB-21-0579
First Posted:
Sep 2, 2021
Last Update Posted:
Sep 2, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Ryne Jackson, Student, The University of Texas Health Science Center, Houston
endodontic treatment
mandibular molar teeth
apical periodontitis.
Additional relevant MeSH terms:
Periodontitis
Periapical Periodontitis
Pain, Postoperative

Study Results

No Results Posted as of Sep 2, 2021