Effects of Topical Anesthesia Approaches on Dental Pain During and After Restorative Management of Dental Caries

Dubai Health

Status: Not yet enrolling

Conditions: Pulpitis; Pain Management

Treatments: Other: Medicated analgesia; Other: Placebo; Device: Photobiomodulation (PBM)-induced analgesia device using multi-wavelength LED

Study type: Interventional

Funder types: Other

Identifiers

NCT07379515

MBRU IRB-2024-695

Details and patient eligibility

About

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.

Enrollment: 204 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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204 participants in 3 patient groups, including a placebo group

Non-medicated anelgesia

Experimental group

Treatment:

Device: Photobiomodulation (PBM)-induced analgesia device using multi-wavelength LED

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo

Medicated anelgesia

Active Comparator group

Treatment:

Other: Medicated analgesia