Health TrialsbyHealthPanel

Photobiomodulation and Tooth Analgesia

ConditionsDental AnaesthesiaDental PainDental Analgesia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorUniversity of Maryland, Baltimore

About this trial

The purpose of this study is to test photobiomodulation (PBM) with a non-invasive light device for reducing discomfort during dental treatments in children. We plan to conduct a series of three clinical studies in 200 school-aged children requiring routine dental treatment. The first study aims to test if PBM works for tooth and soft tissue by assessing response to cold testing and probing of gums. The second study aims to test if use of PBM on soft tissues before injection reduces discomfort. The third study aims to test if PBM can be used to do simple dental fillings in baby teeth without numbing injection.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy children, aged 6-12 years, requiring routine dental treatment

Disqualifiers

Children with uncooperative behavior or signficant medical history

Trial design

Design model

Sequential

Treatments tested in this trial

  • Photobiomodulation

    Device

    Photomodulation (PBM) is a promising non-tissue penetrating (i.e. minimally invasive) approach for achieving tooth and soft tissue anesthesia/analgesia in dental patients. A patent pending near-infrared laser technology that aims to provide dental analgesia will be used for PBM. This intra-oral PBM device comes with a tip comprising of a series of photonic emitters with specific wavelengths that can go through the tooth structure and bone, blocking the nerve conduction like local anesthetics. Research has shown that one burst of light application (for about 20 second) can provide up to 15-20 minutes of pain relief. Based on existing research PBM does not present a serious risk to health, safety, or welfare of a subject.

  • Topical Benzocaine

    Drug

    Topical Benzocaine at injection site to reduce discomfort of local infiltration

  • Local Anesthesia

    Drug

    Local infiltration using local anesthetics with epinephrine

Treatment groups

200 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: PBM- Study 1Experimental treatment 1 intervention
Group B: no PBM - Study 1No intervention 0 interventions
Group C: PBM- Study 2Experimental treatment 1 intervention
Group D: no PBM- Study 2Active comparator 1 intervention
Group E: PBM- Study 3Experimental treatment 1 intervention
Group F: no PBM- Study 3Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

Study 1- Response to Cold Pulp (Pulp sensibility) testing

Name of measurement: Response to cold pulp testing. Measurement tool: Child's acknowledgement of cold sensation. A small amount of cold spray (Endo Ice/Ethyl Chloride) will be sprayed onto a cotton pellet, and gently place the cotton pellet on the middle third of the buccal surface of the tooth for a few seconds or until the child indicates a sensation. Child will be asked to raise their hand when they feel a cold sensation. Unit of measurement: Response will be noted (Yes/No), if the cold sensation is felt by the child on application of cold stimulus. Difference in cold pulp testing between PBM and no PBM group.

Time frame
during the intervention (application of cold stimuli)
2

Study 1- Anxiety related to routine gingival probing

Name of the measurement: Assessment of anxiety Measurement tool: Visual analogue scale (VAS)- a 100-mm horizontal line with two extremes "not anxious" (left) to "very anxious" (right). Measurement unit: rating scale

Time frame
pre-procedure (baseline) and immediately after the procedure
3

Study 1- Pain (physician documented) related to routine gingival probing

Name of the measurement: Heart rate Measurement tool: Pulse oximetry. Unit of measurement: Heart rate per minute

Time frame
pre-procedure (baseline), during procedure, and immediately after procedure
4

Study 1- Self-reported Pain related to routine gingival probing

Name of the measurement: Pain/discomfort Measurement tool: Self-reported Wong Baker faces Scale (six-point scale from score 0 (no hurt) to score 10 (hurts worst). Unit of measurement: Rating Scale

Time frame
pre-procedure (baseline) and immediately after procedure

Secondary outcomes

1

Study 1- Duration of tooth analgesia in PBM group

Name of measurement: Duration or time taken for response to cold pulp testing. Measurement tool: Child's acknowledgement of cold sensation. A small amount of cold spray (Endo Ice/Ethyl Chloride) will be sprayed onto a cotton pellet, and gently place the cotton pellet on the middle third of the buccal surface of the tooth for a few seconds or until the child indicates a sensation. Child will be asked to raise their hand when they feel a cold sensation. Unit of measurement: Time (measured in seconds) taken for response in PBM group and no PBM groups.

Time frame
baseline and immediately after response is felt
2

Study 1- Duration of soft tissue analgesia

Name of measurement: Duration of analgesia or time taken for patient to respond to gingival probing Measurement tool: Yes/No to discomfort experienced during gingival probing Unit of measurement: Time in seconds

Time frame
baseline, immediately after response is felt

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Maryland, Baltimore

Lead sponsor

Source ClinicalTrials.gov
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