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

NCT05032612 | Completed Results FDA Device

• 1 other identifier: HSC-DB-21-0579
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

endodontic treatment; mandibular molar teeth; apical periodontitis.

Outcome Measures

Primary Outcomes (1)

• Pain as Assessed by the Visual Analog Scale

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

  72 hours after treatment

Secondary Outcomes (1)

• Pain as Assessed by the Visual Analog Scale

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

Study Arms (2)

PBM Therapy

EXPERIMENTAL

Device: PBM Therapy

PBM Sham

SHAM COMPARATOR

Device: PBM Sham

Interventions

PBM Therapy DEVICE

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 Therapy

PBM Sham DEVICE

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

PBM Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Posterior mandibular molars
• No previous root canal therapy on the tooth in question
• Able to complete the endodontic treatment in one visit

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Periapical Periodontitis

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Results Point of Contact

• Title: Timothy Kirkpatrick, DDS
• Organization: The University of Texas Health Science Center at Houston

timothy.c.kirkpatrick@uth.tmc.edu

713-486-4227

Study Officials

• Ryne Jackson, DMD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 2, 2021
• Study Start: September 16, 2021
• Primary Completion: March 16, 2022
• Study Completion: March 16, 2022
• Last Updated: March 24, 2023
• Results First Posted: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)