Photobiomodulation for Toothache

Overseen By Kue-Ling Hsu, DDS, MS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Disqualifiers: Uncooperative behavior, significant medical history

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

Compensation: Varies

Number of Visits: 3

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a non-invasive light treatment called photobiomodulation (PBM) to determine its effectiveness in reducing discomfort during dental visits for children. The study examines PBM's impact on tooth and gum sensitivity, its ability to reduce pain from injections, and its potential to assist with simple fillings without numbing shots. It targets healthy children aged 6-12 who require routine dental work.

As an unphased trial, this study provides a unique opportunity for children to potentially experience less discomfort during dental procedures.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this non-invasive light device is safe for reducing discomfort during dental treatments in children?

Research has shown that photobiomodulation (PBM), a type of light therapy, is generally safe and well-tolerated in dental treatments. Some studies have found that PBM can reduce pain and swelling, making it a potentially comfortable option for managing dental discomfort.

PBM has been used to aid wound healing after dental procedures, with treatment times typically lasting between 30 to 120 seconds. Most reports did not indicate any major side effects during these uses. Additionally, two studies found that PBM significantly reduced pain levels, supporting its safety as an effective pain management tool.

While PBM's safety is promising, it remains under study in various settings. However, its non-invasive nature and positive results in past research suggest it is a promising option for those considering joining trials involving PBM. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about photobiomodulation (PBM) for treating toothaches because it offers a non-invasive pain relief option using light therapy, which is quite different from standard treatments like topical anesthetics and local anesthesia. Unlike these traditional methods that rely on numbing agents, PBM uses light to stimulate cellular activity, promoting pain relief and healing. This approach could potentially minimize the need for needles and chemical anesthetics, making dental procedures more comfortable for patients. Additionally, PBM might provide faster pain relief, as it can be applied directly to the problem area and adjusted based on the patient's feedback.

What evidence suggests that photobiomodulation is effective for reducing discomfort during dental treatments in children?

Research has shown that photobiomodulation (PBM), a non-surgical light therapy, may help reduce dental pain. In this trial, participants will join different study arms to assess PBM's effectiveness. A review of studies found PBM effective in reducing pain and swelling after wisdom tooth removal. Other research suggests it can also lessen pain from needles during dental anesthesia. Although more studies are needed, these findings suggest PBM could ease discomfort during dental treatments. Early results are promising, making it a potential option for those seeking pain relief without traditional methods. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for healthy children aged 6-12 who need routine dental treatment. It's not suitable for those outside this age range or with health conditions that might affect the study.

Inclusion Criteria

My child is healthy, aged 6-12, and needs routine dental care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Study 1: PBM Effectiveness

Testing the effectiveness of PBM in tooth and soft tissue analgesia by assessing response to cold pulp testing and gingival probing.

4 weeks

1 visit (in-person)

Study 2: Pre-emptive Analgesic Effect

Assessing the pre-emptive analgesic effect of PBM on soft tissues at the site of injection prior to local anesthesia infiltration.

4 weeks

1 visit (in-person)

Study 3: PBM for Restorative Procedures

Testing the effectiveness of PBM in providing tooth analgesia for simple restorative procedures in primary teeth.

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Photobiomodulation

Trial Overview The trial tests photobiomodulation (PBM), a non-invasive light therapy, against topical benzocaine and local anesthesia to see if it reduces pain during dental procedures in three separate studies on tooth response, discomfort from injections, and effectiveness in filling cavities without numbing.

How Is the Trial Designed?

Group I: PBM- Study 3 Experimental Treatment 1 Intervention

PBM (one burst/ 20 seconds application) followed by traditional tooth preparation with burs/handpiece and placement of restoration. Additional bursts may be provided every 20 minutes depending on the length of the procedure and patient-reported discomfort.

Group II: PBM- Study 2 Experimental Treatment 1 Intervention

PBM (one burst/ 20 seconds application) at injection site (prior to local anesthesia infiltration)

Group III: PBM- Study 1 Experimental Treatment 1 Intervention

In PBM group, the selected tooth will receive one burst of light application (20 seconds) before being subjected to sensibility testing and gingival probing.

Group IV: no PBM- Study 2 Active Control 1 Intervention

Topical benzocaine at injection site (prior to local anesthesia infiltration)

Group V: no PBM - Study 1 Active Control 1 Intervention

In the control (no PBM) group, the selected tooth will be subjected to sensibility testing and gingival probing without PBM.

Group VI: no PBM- Study 3 Active Control 2 Interventions

Topical benzocaine/Local infiltration followed by traditional tooth preparation with burs/handpiece and placement of restoration.

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11148411/

The efficacy of photobiomodulation on dental injection pain Based on current evidence, PBMT may help reduce needle pain related to dental anesthesia. Further standardized studies are needed to assess the significance of ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0300571225005238

Challenges in Evaluating the Analgesic Effects of ... Photobiomodulation (PBM) shows promising potential as a non-invasive analgesic approach in dentistry. However, its integration into clinical ...

3. mdpi.com mdpi.com/2077-0383/13/19/5709

Efficacy of Photobiomodulation in the Management of Pain ... A recent systematic review indicated that LLLT was effective in reducing pain, edema, and trismus after wisdom tooth surgery, defining it as a ...

4. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06988722

Laser Photobiomodulation After Dental Implant Surgery ... Primary outcome: Pain intensity measured using an 11-point Numeric Rating Scale (NRS) at 2, 6, 12, 24, 48, and 72 hours after surgery. Secondary outcomes: ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39407769/

Efficacy of Photobiomodulation in the Management of Pain ... The aim of this study is to quantitatively measure pain and inflammation and to compare the proposed PBM treatment with a simulated treatment ( ...

6. 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 process results in beneficial therapeutic outcomes including, but not limited to, the alleviation of pain or inflammation, immunomodulation, and promotion ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10877507/

Photobiomodulation in dental extraction therapy Clinical wound healing outcomes were reported in 6 articles for 7 groups with treatment times ranging from 30 through 120 seconds and wavelengths from 660 ...

8. mdpi.com mdpi.com/2077-0383/14/15/5210

Effects of Photobiomodulation Therapy (PBMT) in the ... Results: Two studies showed statistically significant reductions in pain with PBMT. Kahraman et al. reported lower pain scores in the intraoral PBMT (p = 0.001) ...