Photobiomodulation for Pain After Root Canal Surgery

Overseen By Juliana Barros, DDS,MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Uncontrolled diabetes, Heavy smokers, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of Photobiomodulation (PBM) in easing pain and aiding healing after root canal surgery. PBM uses special light therapy to potentially reduce pain and improve recovery. The trial compares two groups: one receiving the actual PBM treatment and another receiving a sham treatment for comparison. Suitable participants have a tooth requiring surgery with a specific type of gum cut (flap) and are generally healthy without uncontrolled health issues. As an unphased trial, this study provides an opportunity to explore innovative methods for pain relief and healing.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that photobiomodulation (PBM) is generally safe. PBM is a type of light therapy that does not involve heat or surgery. Studies have found it can help reduce pain and swelling and might also aid in healing tissues. One study found PBM effective in reducing pain after dental treatments. However, some reports suggest that the evidence for PBM's pain-reducing ability is not very strong. There are no major reports of harmful side effects, making PBM a treatment that is usually well-tolerated.

For those considering joining a trial using PBM, this information may provide confidence in its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about photobiomodulation (PBM) therapy for pain after root canal surgery because it offers a non-invasive alternative to traditional pain management methods, like medications or more invasive procedures. Unlike most treatments that rely on pharmaceuticals to manage pain, PBM uses a 660 nm diode laser to stimulate tissue repair and reduce inflammation directly at the site of the surgery. This approach not only minimizes the risk of side effects associated with drugs but also potentially accelerates healing by enhancing cellular activity. By offering a targeted, drug-free solution, PBM could revolutionize post-surgical pain management for dental patients.

What evidence suggests that this trial's treatments could be effective for pain after root canal surgery?

This trial will compare the effects of EMS combined with PBM treatment to EMS combined with a PBM sham treatment. Studies have shown that photobiomodulation (PBM), or light therapy, can significantly reduce pain after dental procedures like root canals. In seven out of nine studies, PBM effectively relieved pain following these procedures. Although some research describes the evidence as not very strong, PBM consistently outperforms sham treatments. This therapy uses a special laser to reduce pain and aid healing, offering a promising option for those seeking relief after dental surgery. ^{3 6 7 8 9}

Who Is on the Research Team?

Juliana Barros, DDS,MS

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for patients at the University of Texas Health Science Center's School of Dentistry who are undergoing endodontic microsurgery (EMS) for various dental pulp and periapical diseases. Participants should be in need of EMS due to conditions like gum disease or nonvital teeth.

Inclusion Criteria

My surgery plan includes a specific flap design.

I am in good or mild systemic disease condition.

At least one tooth will receive EMS

Exclusion Criteria

Any event or condition that would make continued participation in the study not in the best interest of the subject, as determined by the investigator

Initiation of any treatment or exposure that might affect therapy's healing, as determined by the investigator

I have a serious but not life-threatening health condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo endodontic microsurgery (EMS) with either PBM treatment or PBM sham treatment

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain and healing post-surgery using visual analog pain scale and Early Wound Healing Score

1 week

1 visit (in-person) for sutures removal

What Are the Treatments Tested in This Trial?

Interventions

• EMS
• PBM sham treatment
• PBM treatment

Trial Overview The study is testing the effectiveness of Photobiomodulation (PBM), a light therapy, on reducing pain and improving healing after EMS. Patients will receive either actual PBM treatment or a sham (placebo) version to compare outcomes.

How Is the Trial Designed?

Group I: EMS and PBM treatment Experimental Treatment 2 Interventions

Photobiomodulation (PBM) therapy will be performed using a 660 nm diode laser (SiroLaser Advance Plus, Dentsply Sirona Inc, Charlotte, North Carolina, USA) following the outline of the incision flap in a contact mode. Each site will be irradiated for 25 seconds with an energy density of 10 J/cm2 (irradiation mode).

Group II: EMS and PBM sham treatment Placebo Group 2 Interventions

The laser tip will be placed following the outline of the incision flap in a contact mode but without activating it (no irradiation).

EMS is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Electrical Muscle Stimulation for:

• Muscle strengthening and rehabilitation
• Pain management

Approved in European Union as Neuromuscular Electrical Stimulation for:

• Muscle strengthening and rehabilitation
• Pain management

Approved in Canada as EMS for:

• Muscle strengthening and rehabilitation
• Pain management

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Published Research Related to This Trial

This study evaluates the effectiveness of photobiomodulation using LED light therapy in reducing pain, swelling, and trismus after the surgical removal of lower third molars, involving 38 adult participants in a randomized, double-blind, placebo-controlled trial.

Preliminary results suggest that LED therapy may improve postoperative recovery outcomes, including quality of life, although this is the first study specifically investigating LED efficacy in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of diode-emitting diode (LED) photobiomodulation in pain management, facial edema, trismus, and quality of life after extraction of retained lower third molars: A randomized, double-blind, placebo-controlled clinical trial. Tenis, CA., Martins, MD., Gonçalves, MLL., et al.[2022]

In a study of 20 patients with inferior alveolar nerve injury after wisdom tooth extraction, those treated with photobiomodulation (PBM) therapy showed significantly greater improvement in pain and nerve function compared to those receiving mecobalamine treatment.

PBM therapy using an 808-nm laser was effective in managing postoperative paresthesia, suggesting it could be a promising treatment option, although further research with larger trials is necessary to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation therapy for management of inferior alveolar nerve injury post-extraction of impacted lower third molars. Qi, W., Wang, Y., Huang, YY., et al.[2022]

In a study involving 20 patients undergoing crown lengthening surgery, photobiomodulation using a diode laser significantly reduced pain intensity on the third day post-surgery compared to a control group, indicating its efficacy in pain management.

While both groups reported pain relief over time, the laser group experienced notably lower pain levels (2.90±0.74) on day three compared to the control group (4.0±0.67), highlighting the potential of photobiomodulation as a beneficial treatment following dental procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of photobiomodulation on pain control after clinical crown lengthening surgery. Sadighi, M., Faramarzi, M., Chitsazha, R., et al.[2022]

Photobiomodulation therapy (PBMT) has been shown to effectively reduce pain, swelling, and trismus after third molar tooth extractions, based on a review of 46 clinical trials.

Optimal PBMT parameters for pain relief include wavelengths of 650-980 nm, power settings between 4-300 mW, and energy densities of 3-85.7 J/cm², highlighting the need for standardized protocols in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation in Oral Surgery: A Review. Hosseinpour, S., Tunér, J., Fekrazad, R.[2020]

Low-level laser energy irradiation (LLEI) showed no significant benefits in reducing pain or swelling after the surgical removal of impacted mandibular third molars, based on a systematic review of 10 trials.

However, LLEI did result in a moderate reduction in trismus, with patients experiencing 4.2 mm and 5.2 mm less trismus on days 2 and 7 post-surgery, respectively, compared to those receiving no active treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is adjuvant laser therapy effective for preventing pain, swelling, and trismus after surgical removal of impacted mandibular third molars? A systematic review and meta-analysis. Brignardello-Petersen, R., Carrasco-Labra, A., Araya, I., et al.[2022]

In a study involving 60 patients undergoing endodontic treatment, photobiomodulation therapy (PBM) with low-level laser irradiation significantly reduced the prevalence of postoperative pain at 6 and 24 hours after treatment compared to a control group that did not receive PBM.

The results suggest that PBM therapy can be an effective adjunct to endodontic procedures, potentially benefiting patients by minimizing pain following treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of photobiomodulation therapy on postoperative pain after endodontic treatment: a randomized, controlled, clinical study. Lopes, LPB., Herkrath, FJ., Vianna, ECB., et al.[2020]

In a randomized clinical trial involving 44 patients with symptomatic irreversible pulpitis, the use of photobiomodulation (PBM) therapy before anesthesia significantly reduced the need for supplemental injections during endodontic treatment.

Patients who received PBM reported lower pain intensity during procedures compared to those who did not receive the laser treatment, indicating that PBM effectively enhances the depth of anesthesia in dental procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Photobiomodulation on the Depth of Anesthesia During Endodontic Treatment of Teeth With Symptomatic Irreversible Pulpitis (Double Blind Randomized Clinical Trial). Ghabraei, S., Chiniforush, N., Bolhari, B., et al.[2020]

Low-level laser therapy (LLLT) appears to significantly reduce postoperative pain after endodontic treatments, according to a review of 12 studies, although the overall quality of evidence is considered low to very low.

There is a need for further research due to inconsistencies in laser parameters and medication use across studies, which may affect the reliability of the findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of low-level laser therapy on postoperative endodontic pain: An updated systematic review. Guerreiro, MYR., Monteiro, LPB., de Castro, RF., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10899165/

Effect of photobiomodulation on postoperative endodontic pain Seven out of nine studies showed that PMB has a significant impact on relieving postoperative endodontic pain, with no statistically significant difference.

2. mdpi.com mdpi.com/2075-4426/15/8/347

Effect of Photobiomodulation on Post-Endodontic Pain ... The evidence for photobiomodulation in reducing postoperative pain after endodontic instrumentation is classified as low or very low certainty, indicating a ...

3. nature.com nature.com/articles/s41598-024-74998-x

Lasers efficacy in pain management after primary and ... Intraoral laser therapy demonstrated no significant advantage over conventional treatments but consistently outperformed placebo, particularly ...

4. liebertpub.com liebertpub.com/doi/full/10.1089/photob.2023.0129?doi=10.1089/photob.2023.0129

Effect of Laser Photobiomodulation on Postoperative Pain ... Application of photobiomodulation before anesthesia is effective in reducing pain and supplementary injection during root canal therapy. Luana ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1572100024003302

Effectiveness of Low-Level Laser Therapy in reducing ... A single dose of 22.5 J LLLT per implant helps to decrease postoperative pain in dental implant surgery at 24 h for partially edentulous patients.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11674469/

Effect of Laser Photobiomodulation on Postoperative Pain ... Conclusions: Laser photobiomodulation (PBM) was found to be effective in reducing postoperative pain following single-visit endodontic treatment ...

7. ada.org ada.org/-/media/project/ada-organization/ada/ada-org/files/resources/practice/dental-standards/aip-review/189_aip_11_23.pdf

PHOTOBIOMODULATION (PBM) IN ORAL HEALTH This non-thermal and non-surgical light treatment has been noted to reduce pain or inflammation, modulate immune responses, and promote tissue healing and ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S199179022400285X

The impact of low-level laser therapy (photobiomodulation) ... Does the use of low-level light therapy postoperatively reduce pain, oedema, and neurosensory disorders following orthognathic surgery? a systematic review.

9. bmcoralhealth.biomedcentral.com bmcoralhealth.biomedcentral.com/articles/10.1186/s12903-025-06216-7

Protocol for low-level laser therapy (LLLT) to control post ... This blind clinical trial protocol was designed to evaluate the analgesic effect of low-level laser therapy (LLLT) and its impact on post- ...