Symptomatic Apical PeriodontitisNCT07886723
Photobiomodulation After Nonsurgical Root Canal Treatment
A study testing Adjunctive Photobiomodulation in people with Symptomatic Apical Periodontitis and Postoperative Pain, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Symptomatic Apical Periodontitis, Postoperative Pain, Mechanical Allodynia
- What is being tested?
- Adjunctive Photobiomodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2026to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 24Show fewer
- 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
- Prisoners
- Adults lacking capacity to consent or adults with diminished or fluctuating capacity to consent
- Non-English speakers
- Individuals unable to read
- Employees of the researcher
- Students of the researcher
- Individuals with a serious health condition for which there are no satisfactory standard treatments
- Individuals with fear of negative consequences for not participating
- Any other circumstance that could increase vulnerability to coercion or exploitation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Minnesota School of Dentistry Graduate Endodontic Clinic
Minneapolis, Minnesota, 55455
Sophie Bengson, 701-240-7238, bengs027@umn.edu
Ronald Ordinola-Zapata,, DDS, MS, PhD
About this study
Official title: Effect of Adjunctive Photobiomodulation on Mechanical Allodynia and Postoperative Pain Following Nonsurgical Root Canal Treatment in Teeth With Symptomatic Apical Periodontitis
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.
Read the detailed description
Postoperative pain and mechanical allodynia are common concerns after nonsurgical root canal treatment, particularly in teeth diagnosed with symptomatic apical periodontitis. Mechanical allodynia may reduce functional biting capacity and contribute to discomfort even after endodontic treatment.
Photobiomodulation is a noninvasive therapeutic approach using low-level laser energy to stimulate cellular responses without producing thermal tissue damage. It has been studied for analgesic and anti-inflammatory effects, but prior endodontic studies have mainly relied on subjective pain measures. This study combines a patient-reported pain outcome with an objective functional measure of recovery using maximum occlusal force.
This study will enroll 60 adults presenting to the University of Minnesota School of Dentistry Graduate Endodontic Clinic for primary nonsurgical root canal treatment of a tooth diagnosed with symptomatic apical periodontitis. Participants will be randomized 1:1 to adjunctive photobiomodulation or sham photobiomodulation.
All participants will receive standardized nonsurgical root canal treatment in a single appointment. Participants randomized to adjunctive photobiomodulation will receive PBM using the Fotona LightWalker Nd:YAG laser immediately after obturation. Participants randomized to the sham group will undergo an identical simulated laser procedure without laser energy delivery.
Outcome assessments will be completed at baseline, 2 days after treatment, and 7 to 10 days after treatment. Mechanical allodynia will be assessed by measuring maximum occlusal force on the treated tooth and the corresponding contralateral asymptomatic tooth. Postoperative pain will be assessed using the Numeric Rating Scale in response to percussion testing.
- Being tested
- Adjunctive Photobiomodulation, Sham Photobiomodulation
- Keywords
- Endodontic Disease, Root Canal Treatment
- Medical subject headings
- Pain, Postoperative, Hyperalgesia, Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjunctive PhotobiomodulationDevice
Also called Fotona LightWalker Nd:YAG Laser
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.
Sham PhotobiomodulationDevice
Also called Simulated Laser Procedure
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 7 to 10 days after treatment
Secondary outcomes (3)
Change in Postoperative Pain Measured by Numeric Rating Scale
Postoperative pain will be assessed using the 11-point Numeric Rating Scale in response to percussion testing of the treated tooth. The secondary endpoint is the change in Numeric Rating Scale pain score from baseline to follow-up.
Measured: Baseline
Change in Postoperative Pain Measured by Numeric Rating Scale
Postoperative pain will be assessed using the 11-point Numeric Rating Scale in response to percussion testing of the treated tooth. The secondary endpoint is the change in Numeric Rating Scale pain score from baseline to follow-up.
Measured: 2 days after treatment
Change in Postoperative Pain Measured by Numeric Rating Scale
Postoperative pain will be assessed using the 11-point Numeric Rating Scale in response to percussion testing of the treated tooth. The secondary endpoint is the change in Numeric Rating Scale pain score from baseline to follow-up.
Measured: 7 to 10 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start19 Oct 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Apical PeriodontitisStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronald Ordinola-Zapata, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07886723
- Sponsor's protocol ID
- STUDY00029266
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adjunctive Photobiomodulation on Mechanical Allodynia and Postoperative Pain Following Nonsurgical Root Canal Treatment in Teeth With Symptomatic Apical Periodontitis
- ClinicalTrials.gov ID
- NCT07886723
- Acronym / sponsor ID
- STUDY00029266
- Keywords
- Endodontic Disease, Root Canal Treatment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 19 Oct 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 21 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Postoperative pain and mechanical allodynia are common concerns after nonsurgical root canal treatment, particularly in teeth diagnosed with symptomatic apical periodontitis. Mechanical allodynia may reduce functional biting capacity and contribute to discomfort even after endodontic treatment.
Photobiomodulation is a noninvasive therapeutic approach using low-level laser energy to stimulate cellular responses without producing thermal tissue damage. It has been studied for analgesic and anti-inflammatory effects, but prior endodontic studies have mainly relied on subjective pain measures. This study combines a patient-reported pain outcome with an objective functional measure of recovery using maximum occlusal force.
This study will enroll 60 adults presenting to the University of Minnesota School of Dentistry Graduate Endodontic Clinic for primary nonsurgical root canal treatment of a tooth diagnosed with symptomatic apical periodontitis. Participants will be randomized 1:1 to adjunctive photobiomodulation or sham photobiomodulation.
All participants will receive standardized nonsurgical root canal treatment in a single appointment. Participants randomized to adjunctive photobiomodulation will receive PBM using the Fotona LightWalker Nd:YAG laser immediately after obturation. Participants randomized to the sham group will undergo an identical simulated laser procedure without laser energy delivery.
Outcome assessments will be completed at baseline, 2 days after treatment, and 7 to 10 days after treatment. Mechanical allodynia will be assessed by measuring maximum occlusal force on the treated tooth and the corresponding contralateral asymptomatic tooth. Postoperative pain will be assessed using the Numeric Rating Scale in response to percussion testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Adjunctive Photobiomodulation | Experimental | Device: Adjunctive PhotobiomodulationParticipants will receive standard nonsurgical root canal treatment followed by adjunctive photobiomodulation using the Fotona LightWalker Nd:YAG laser immediately after obturation. |
| Sham Photobiomodulation | Sham comparator | Device: Sham PhotobiomodulationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adjunctive PhotobiomodulationAlso: Fotona LightWalker Nd:YAG LaserAdjunctive 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. | Device | Adjunctive Photobiomodulation |
| Sham PhotobiomodulationAlso: Simulated Laser ProcedureThe 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. | Device | Sham Photobiomodulation |
Primary outcome
Change in Mechanical Allodynia Measured by Maximum Occlusal Force Difference
Time frame: Baseline
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.
Change in Mechanical Allodynia Measured by Maximum Occlusal Force Difference
Time frame: 2 days after treatment
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.
Change in Mechanical Allodynia Measured by Maximum Occlusal Force Difference
Time frame: 7 to 10 days after treatment
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.
3 secondary outcomes
Change in Postoperative Pain Measured by Numeric Rating Scale
Time frame: Baseline
Change in Postoperative Pain Measured by Numeric Rating Scale
Time frame: 2 days after treatment
Change in Postoperative Pain Measured by Numeric Rating Scale
Time frame: 7 to 10 days after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ronald Ordinola-Zapata principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adjunctive Photobiomodulation in people with Symptomatic Apical Periodontitis and Postoperative Pain, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophie Bengson (701-240-7238, bengs027@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mechanical Allodynia Measured by Maximum Occlusal Force Difference (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.