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

NCT07379515 | Not Yet Recruiting

• 1 other identifier: MBRU IRB-2024-695
• Study Type: interventional
• Target: 204
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 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. 2.Intervention: Participants would be randomly assigned to different groups based on the type or method of topical anesthesia being tested.
3. 3.Treatment Procedure: Dental caries management would be performed under local anesthesia, with the designated topical anesthetic applied beforehand.
4. 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. 5.Follow-Up: Participants might be monitored for a short duration post-treatment to assess any residual pain or side effects.

Conditions

Pain Management; Pulpitis

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 5 minutes after local anesthesia administration, during dental procedure, directly after finishing the procedure, and 48 hours postoperatively.

Secondary Outcomes (5)

• Pain score with prick pain test (PPT)

  One minute after topical anesthesia.

• Pain score with pulpal stimulation using electric pulp tester (EPT)

  After 2 minutes of topical anesthesia.

• Amount of local anesthesia to be given

  At the end of dental procedure.

• Need for additional analgesics

  Within 48 hours postoperatively.

• Reporting of any adverse effects, such as mucosal irritation, allergic reactions, and delayed pain relief.

  Within 48 hours postoperatively.

Study Arms (3)

Non-medicated anelgesia

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Medicated anelgesia

ACTIVE COMPARATOR

Other: Medicated analgesia

Interventions

Medicated analgesia OTHER

Topical anesthesia (Benzocaine 20%)

Medicated anelgesia

Placebo OTHER

Placebo with no intervention.

Placebo

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

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

Non-medicated anelgesia

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dubai Health: lead

MeSH Terms

Conditions

Pulpitis; Agnosia

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: January 30, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share