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

Primary Purpose

Postoperative Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

PBM Therapy

PBM Sham

About this trial

This is an interventional supportive care trial for Postoperative Pain focused on measuring endodontic treatment, mandibular molar teeth, apical periodontitis.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

PBM Therapy

PBM Sham

Arm Description

Outcomes

Primary Outcome Measures

Pain as Assessed by the Visual Analog Scale

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

Secondary Outcome Measures

Pain as Assessed by the Visual Analog Scale

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

Full Information

NCT ID

NCT05032612

First Posted

August 26, 2021

Last Updated

March 1, 2023

Sponsor

The University of Texas Health Science Center, Houston

1. Study Identification

Unique Protocol Identification Number

NCT05032612

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

September 16, 2021 (Actual)

Primary Completion Date

March 16, 2022 (Actual)

Study Completion Date

March 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

Keywords

endodontic treatment, mandibular molar teeth, apical periodontitis.

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PBM Therapy

Arm Type

Experimental

Arm Title

PBM Sham

Arm Type

Sham Comparator

Intervention Type

Device

Intervention Name(s)

PBM Therapy

Intervention Description

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 .

Intervention Type

Device

Intervention Name(s)

PBM Sham

Intervention Description

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

Primary Outcome Measure Information:

Title

Pain as Assessed by the Visual Analog Scale

Description

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

Time Frame

72 hours after treatment

Secondary Outcome Measure Information:

Title

Pain as Assessed by the Visual Analog Scale

Description

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

Time Frame

0 hours, 6 hours, 12 hours and 24 hours hours after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ryne Jackson, DMD

Organizational Affiliation

The University of Texas Health Science Center, Houston

Official's Role

Principal Investigator

Facility Information:

Facility Name

The University of Texas Health Science Center at Houston

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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