About this trial
The purpose of the Research Study and Overview of Participation: This study will compare different approaches used to prevent pain when giving local anesthesia to numb the teeth while managing dental cavities and decay. Specifically, it seeks to determine which approach will reduce the pain and discomfort during or after the procedure. This will help dentists to choose the best approach to reduce patient's pain and discomfort and improve the overall experience of dental treatment.
Participants in the study would likely undergo the following:
1. Screening and Consent: Participants would be assessed for eligibility (e.g., age, health status, and presence of dental caries requiring treatment) and would provide informed consent. 2. Intervention: Participants would be randomly assigned to different groups based on the type or method of topical anesthesia being tested. 3. Treatment Procedure: Dental caries management would be performed under local anesthesia, with the designated topical anesthetic applied beforehand. 4. Pain Assessment: Participants would rate their pain levels during and after the procedure using validated pain measurement scales (e.g., visual analog scale). 5. Follow-Up: Participants might be monitored for a short duration post-treatment to assess any residual pain or side effects.
This design ensures that the study collects reliable data on the effectiveness of the different topical anesthetic approaches while prioritizing patient safety and comfort.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Healthy participants: American Society of Anesthesiology Class I or II
Adults aged 18-59 years
No history of allergy to local anesthesia or excipients included in the vial
Participant requiring caries management for a maxillary premolar tooth (ICDAS I-V), with reversible pulpitis.
Disqualifiers
American Society of Anesthesiology Class III or higher
Participants with systemic conditions affecting pain perception
Participants on chronic pain medication
Pregnant or breastfeeding women
Trial design
Parallel
Treatments tested in this trial
Photobiomodulation (PBM)-induced analgesia device using multi-wavelength LED
DevicePhotobiomodulation (PBM)-induced analgesia device using multi-wavelength LED
Medicated analgesia
Other interventionTopical anesthesia (Benzocaine 20%)
Placebo
Other interventionPlacebo with no intervention.
Treatment groups
Trial outcomes
Primary outcomes
Pain score after local anesthesia administration, dental procedure, and 48 hours postoperatively.
Pain score based on Visual Analog Scale (1-10) with highest score indicates the most severe pain.
Secondary outcomes
Pain score with prick pain test (PPT)
Pain score will be reported as "pain" or "no pain".
Pain score with pulpal stimulation using electric pulp tester (EPT)
Digital reading from 1 to 64 with the highest score indicates no pain response on electric stimulation.
Amount of local anesthesia to be given
Counting the number of used local anesthetic carpules.
Need for additional analgesics
Count the number and dose of oral analgesics taken by the patient.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: