Photobiomodulation After Nonsurgical Root Canal Treatment

NCT07886723 | Not Yet Recruiting FDA Device

• 1 other identifier: STUDY00029266
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, double-blind controlled clinical trial will evaluate whether adjunctive photobiomodulation improves recovery after nonsurgical root canal treatment in adults with teeth diagnosed with symptomatic apical periodontitis. Participants will receive standard nonsurgical root canal treatment and will be randomized to adjunctive photobiomodulation using the Fotona LightWalker Nd:YAG laser or to an identical simulated laser procedure without laser energy delivery. The study will evaluate mechanical allodynia using maximum occlusal force measurements comparing the treated tooth with the contralateral asymptomatic tooth. Postoperative pain will also be assessed using the Numeric Rating Scale after percussion testing.

Conditions

Symptomatic Apical Periodontitis; Postoperative Pain; Mechanical Allodynia

Keywords

Endodontic Disease; Root Canal Treatment

Outcome Measures

Primary Outcomes (3)

• Change in Mechanical Allodynia Measured by Maximum Occlusal Force Difference

  Mechanical allodynia will be evaluated by measuring maximum occlusal force on the treated tooth and the corresponding contralateral asymptomatic tooth. The primary endpoint is the change in the difference in maximum occlusal force between the treated and contralateral teeth from baseline to follow-up.

  Baseline

• Change in Mechanical Allodynia Measured by Maximum Occlusal Force Difference

  Mechanical allodynia will be evaluated by measuring maximum occlusal force on the treated tooth and the corresponding contralateral asymptomatic tooth. The primary endpoint is the change in the difference in maximum occlusal force between the treated and contralateral teeth from baseline to follow-up.

  2 days after treatment

• Change in Mechanical Allodynia Measured by Maximum Occlusal Force Difference

  Mechanical allodynia will be evaluated by measuring maximum occlusal force on the treated tooth and the corresponding contralateral asymptomatic tooth. The primary endpoint is the change in the difference in maximum occlusal force between the treated and contralateral teeth from baseline to follow-up.

  7 to 10 days after treatment

Secondary Outcomes (3)

• Change in Postoperative Pain Measured by Numeric Rating Scale

  Baseline

• Change in Postoperative Pain Measured by Numeric Rating Scale

  2 days after treatment

• Change in Postoperative Pain Measured by Numeric Rating Scale

  7 to 10 days after treatment

Other Outcomes (1)

• Adverse Events and Treatment-Related Complications

  Treatment visit through 7 to 10 days after treatment

Study Arms (2)

Adjunctive Photobiomodulation

EXPERIMENTAL

Participants will receive standard nonsurgical root canal treatment followed by adjunctive photobiomodulation using the Fotona LightWalker Nd:YAG laser immediately after obturation.

Device: Adjunctive Photobiomodulation

Sham Photobiomodulation

SHAM COMPARATOR

Participants will receive standard nonsurgical root canal treatment followed by a simulated laser procedure. The laser handpiece will be positioned identically and treatment steps will be replicated, but laser energy will not be delivered.

Device: Sham Photobiomodulation

Interventions

Adjunctive Photobiomodulation DEVICE

Adjunctive photobiomodulation will be delivered using the Fotona LightWalker laser system in Nd:YAG mode immediately after completion of nonsurgical root canal treatment and obturation. The laser will be applied intraorally over the mucosa corresponding to the periapical region using a standardized protocol.

Also known as: Fotona LightWalker Nd:YAG Laser

Adjunctive Photobiomodulation

Sham Photobiomodulation DEVICE

The sham procedure will simulate photobiomodulation treatment. The laser handpiece will be positioned in the same manner and all aspects of the laser procedure will be replicated, but laser energy will not be delivered. Protective eyewear or a visual barrier will be used to maintain participant blinding.

Also known as: Simulated Laser Procedure

Sham Photobiomodulation

Eligibility Criteria

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

You may qualify if:

• Adults 18 years of age or older
• Able to understand the study procedures and provide written informed consent
• Presenting for primary nonsurgical root canal treatment at the University of Minnesota School of Dentistry Graduate Endodontic Clinic
• A tooth diagnosed with symptomatic apical periodontitis
• A pulpal diagnosis of symptomatic irreversible pulpitis or pulp necrosis
• Study tooth is restorable and appropriate for completion of nonsurgical root canal treatment in a single visit
• Presence of a functional opposing tooth suitable for reproducible maximum occlusal force measurements
• Able to comply with study procedures, including percussion testing and maximum occlusal force measurements
• Able and willing to return for the scheduled follow-up visit 7 to 10 days after treatment

You may not qualify if:

• Younger than 18 years of age
• Unable or unwilling to provide informed consent in English
• Pregnant or known or suspected pregnancy
• Previous root canal treatment of the study tooth
• Study tooth cannot be treated and obturated during a single treatment visit
• Non-restorable tooth, vertical root fracture, root resorption, or suspected or confirmed crack extending onto the root surface
• Acute apical abscess requiring incision and drainage or other urgent surgical treatment
• Advanced periodontal disease or tooth mobility that may interfere with maximum occlusal force measurements
• Current chronic opioid therapy or chronic use of medications that, in the opinion of the investigator, would significantly alter pain perception or interfere with study outcome measures
• Unable or unwilling to return for the scheduled follow-up visit
• Any medical, physical, or cognitive condition that, in the opinion of the investigator, would prevent safe participation or completion of study procedures
• Children
• Pregnant women/persons
• Fetuses
• Neonates

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota School of Dentistry Graduate Endodontic Clinic

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Hyperalgesia; Dental Pulp Diseases

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Somatosensory Disorders; Sensation Disorders; Nervous System Diseases; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Ronald Ordinola-Zapata

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie Bengson

CONTACT

701-240-7238; bengs027@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants receiving nonsurgical root canal treatment for teeth diagnosed with symptomatic apical periodontitis will be randomized 1:1 to adjunctive photobiomodulation or sham/simulated laser treatment. Participants in both groups will receive standard nonsurgical root canal treatment. The experimental group will receive adjunctive PBM using the Fotona LightWalker Nd:YAG laser immediately after obturation, while the control group will undergo an identical simulated laser procedure without laser energy delivery.

Study Record Dates

• First Submitted: October 14, 2026
• First Posted: October 21, 2026
• Study Start: October 19, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: October 21, 2026

Record last verified: 2026-10

Locations

US (1)