Evaluation of a Photobiomodulation Device for Dental Analgesia in Pediatric Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Study 1- Response to Cold Pulp (Pulp sensibility) testing
Study Overview
Brief Summary
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.
Detailed Description
Dental anxiety and fear of pain during procedures are major barriers to oral health care, especially among children. Traditional local anesthesia injections can be distressing for pediatric patients. The fear of needle and dental pain are perhaps among the top reasons for avoidance of dental care. Photomodulation (PBM) is a promising non-tissue penetrating (i.e. minimally invasive) approach for achieving tooth and soft tissue anesthesia/analgesia in dental patients.Investigators plan to use an intra-oral PBM device 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. This could significantly reduce dental anxiety and facilitate access to care and the implications of such an alternative to needles will be a gamechanger especially in pediatric dentistry. The proposed randomzied clinical trials will evaluate if photobiomodulation (PBM) with the near-infrared device produces dental analgesia comparable to local anesthetic injection in pediatric patients. This will be a series of three prospective, clinical studies in 200 school-aged children aged 6-12 years requiring routine dental procedures. The first trial will test the effectiveness of PBM in tooth and soft tissue analgesia by assessing response to diagnostic approaches such as cold pulp testing and gingival probing. The second trial will assess the pre-emptive analgesic effect of PBM on soft tissues at the site of injection prior to local anesthesia infiltration to reduce the discomfort of injection, and the third trial will assess effectiveness of PBM in providing tooth analgesia (compared to routinely used topical anesthesia/local infiltration) for simple restorative procedures in primary teeth.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 6 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy children, aged 6-12 years, requiring routine dental treatment
Exclusion Criteria
- •Children with uncooperative behavior or signficant medical history
Arms & Interventions
no PBM- Study 3
Topical benzocaine/Local infiltration followed by traditional tooth preparation with burs/handpiece and placement of restoration.
Intervention: Topical Benzocaine (Drug)
no PBM- Study 3
Topical benzocaine/Local infiltration followed by traditional tooth preparation with burs/handpiece and placement of restoration.
Intervention: Local Anesthesia (Drug)
PBM- Study 1
In PBM group, the selected tooth will receive one burst of light application (20 seconds) before being subjected to sensibility testing and gingival probing.
Intervention: Photobiomodulation (Device)
PBM- Study 2
PBM (one burst/ 20 seconds application) at injection site (prior to local anesthesia infiltration)
Intervention: Photobiomodulation (Device)
PBM- Study 3
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.
Intervention: Photobiomodulation (Device)
no PBM - Study 1
In the control (no PBM) group, the selected tooth will be subjected to sensibility testing and gingival probing without PBM.
no PBM- Study 2
Topical benzocaine at injection site (prior to local anesthesia infiltration)
Intervention: Topical Benzocaine (Drug)
Outcomes
Primary Outcomes
Study 1- Response to Cold Pulp (Pulp sensibility) testing
Time Frame: during 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 probing
Time Frame: pre-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 probing
Time Frame: 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 1- Self-reported Pain related to routine gingival probing
Time Frame: 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- Anxiety related to local anesthesia injection (local infiltration)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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 procedure
Time Frame: 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 3- Pain (physician documented) during restorative procedure
Time Frame: 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 3- Self-reported Pain during restorative procedure
Time Frame: 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 3- Cooperative behavior during restorative procedure
Time Frame: 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
Secondary Outcomes
- Study 1- Duration of tooth analgesia in PBM group(baseline and immediately after response is felt)
- Study 1- Duration of soft tissue analgesia(baseline, immediately after response is felt)