Effects of Topical Anesthesia Approaches on Dental Pain During and After Restorative Management of Dental Caries - Randomized Clinical Trial
| Registry | NCT07379515 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 204 (Estimated) |
| Sponsor | Dubai Health (Other gov) |
| Conditions | Pulpitis, Pain Management |
| Interventions | Photobiomodulation (PBM)-induced analgesia device using multi-wavelength LED, Medicated analgesia, Placebo (Device, other) |
| Dates | start 2026-04-15 (estimated), primary completion 2026-07-31 (estimated), completion 2027-03-31 (estimated), first posted 2026-01-30, last updated 2026-04-13 |
Related Papers Related Patents Related Grants Related Experts
All trials for Pulpitis All trials for Pain Management All trials of Photobiomodulation (PBM)-induced analgesia device using multi-wavelength LED All trials of Medicated analgesia
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Non-medicated anelgesia | Experimental | Device: Photobiomodulation (PBM)-induced analgesia device using multi-wavelength LED | |
| Placebo | Placebo comparator | Other: Placebo | Placebo |
| Medicated anelgesia | Active comparator | Other: Medicated analgesia |
Sex: All, ages: 18 Years to 59 Years
Inclusion Criteria: * 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. Exclusion Criteria: * American Society of Anesthesiology Class III or higher * Participants with systemic conditions affecting pain perception * Participants on chronic pain medication * Pregnant or breastfeeding women * History of allergy to topical/local anesthesia * Taking any analgesic 48 hours before testing, such as an NSAID, opioids, or * acetaminophen * Recent oral trauma * Deep carious lesion with irreversible pulpitis or pulpal necrosis