Photobiomodulation for Dental Pain in Children
This study is testing a new, gentle way to reduce discomfort during dental treatments for children aged 6 to 12. It uses a special light device called photobiomodulation (PBM) to help with tooth and gum pain. The study will compare PBM to traditional methods like topical benzocaine (a numbing gel) and local anesthesia (numbing injections). The goal is to see if PBM can reduce pain and anxiety during dental procedures, potentially even for simple fillings without injections. We are looking for 200 healthy children who need routine dental care. Success will be measured by how children respond to cold tests on their teeth, their anxiety levels, and the pain they report during gum probing.
- Study design
- This is an interventional study planning to enroll 200 school-aged children. It involves a series of three clinical studies.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Pain and anxiety are measured during and immediately after procedures. Response to cold pulp testing is measured during the intervention.
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Photobiomodulation and Tooth Analgesia
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Study 1- Response to Cold Pulp (Pulp sensibility) testingduring the intervention (application of cold stimuli)
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.
- Study 1- Anxiety related to routine gingival probingpre-procedure (baseline) and immediately after the procedure
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
- Study 1- Pain (physician documented) related to routine gingival probingpre-procedure (baseline), during procedure, and immediately after procedure
Name of the measurement: Heart rate Measurement tool: Pulse oximetry. Unit of measurement: Heart rate per minute
- Study 1- Self-reported Pain related to routine gingival probingpre-procedure (baseline) and immediately after procedure
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
- Study 2- Anxiety related to local anesthesia injection (local infiltration)pre-procedure (baseline) and immediately after the procedure
Name of the measurement: Assessment of procedural 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
- Study 2- Pain (physician documented) related to local anesthesia injection (local infiltration)pre-procedure (baseline), during procedure, and immediately after procedure
Name of the measurement: Heart rate Measurement tool: Pulse oximetry. Unit of measurement: Heart rate per minute
- Study 2- Self-reported Pain related to local anesthesia injection (local infiltration)pre-procedure (baseline) and immediately after procedure
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
- Study 2- Cooperative behavior related to local anesthesia injection (local infiltration)pre-procedure (baseline), during, and immediately after procedure
Name of the measurement: Cooperative behavior Measurement tool: Frankel's Behavior rating scale (definitely negative, negative, positive, definitely positive) Unit of measurement: Rating Scale
- Study 3- Anxiety during restorative procedurepre-procedure (baseline) and immediately after the procedure
Name of the measurement: Assessment of procedural 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
- Study 3- Pain (physician documented) during restorative procedurepre-procedure (baseline), during procedure, and immediately after procedure
Name of the measurement: Heart rate Measurement tool: Pulse oximetry. Unit of measurement: Heart rate per minute
- Study 3- Self-reported Pain during restorative procedurepre-procedure (baseline) and immediately after procedure
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
- Study 3- Cooperative behavior during restorative procedurepre-procedure (baseline), during, and immediately after procedure
Name of the measurement: Cooperative behavior Measurement tool: Frankel's Behavior rating scale (definitely negative, negative, positive, definitely positive) Unit of measurement: Rating Scale