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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the effect of Photobiomodulation (PBM) in postoperative pain after endodontic microsurgery (EMS) in patients from the University of Texas Health Science Center at Houston, School of Dentistry Graduate Endodontic Clinic and to assess the soft tissue healing of the vertical releasing incision (VRI) after PBM

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.

What data supports the effectiveness of this treatment for pain after root canal surgery?

Research shows that photobiomodulation therapy (PBM), which uses low-level laser therapy (LLLT), can effectively reduce pain after various dental surgeries, including endodontic treatments and tooth extractions. Studies indicate that PBM helps in pain relief, swelling reduction, and improved recovery, suggesting it may be beneficial for managing pain after root canal surgery. ^{1 2 3 4 5}

Is photobiomodulation therapy safe for humans?

Research suggests that photobiomodulation therapy (PBM), also known as low-level laser therapy (LLLT), is generally safe for humans. It has been used in various dental procedures to reduce pain, swelling, and improve healing without significant safety concerns. ^{1 2 4 6 7}

How does photobiomodulation treatment differ from other treatments for pain after root canal surgery?

Photobiomodulation (PBM) treatment is unique because it uses low-level laser therapy to reduce pain and promote healing by stimulating cellular processes, unlike traditional pain medications that primarily block pain signals. This non-invasive approach can also help with swelling and tissue recovery, making it a novel option for managing postoperative discomfort. ^{1 2 3 4 8}

Research Team

Juliana Barros, DDS,MS

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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

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

I have no health issues that could interfere with the treatment.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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 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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Effect of photobiomodulation therapy on postoperative pain after endodontic treatment: a randomized, controlled, clinical study. [2020]

2. United States 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. [2022]

3. Iran pubmed.ncbi.nlm.nih.gov

Effect of photobiomodulation on pain control after clinical crown lengthening surgery. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Photobiomodulation in Oral Surgery: A Review. [2020]

5. Scotland pubmed.ncbi.nlm.nih.gov

Effect of low-level laser therapy on postoperative endodontic pain: An updated systematic review. [2022]

6. United States 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. [2022]

7. Iran 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). [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Photobiomodulation therapy for management of inferior alveolar nerve injury post-extraction of impacted lower third molars. [2022]