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

Effects of Topical Anesthesia Approaches on Dental Pain During and After Restorative Management of Dental Caries - Randomized Clinical 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain Management; Pulpitis
• Intervention / Treatment: Device: Photobiomodulation (PBM)-induced analgesia device using multi-wavelength LED; Other: Placebo; Other: Medicated analgesia

• Study Type: Interventional
• Enrollment (Estimated): 204
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Placebo with no intervention.
Experimental: Non-medicated anelgesia	Device: Photobiomodulation (PBM)-induced analgesia device using multi-wavelength LED; Photobiomodulation (PBM)-induced analgesia device using multi-wavelength LED
Active Comparator: Medicated anelgesia	Other: Medicated analgesia; Topical anesthesia (Benzocaine 20%)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score with prick pain test (PPT)	Pain score will be reported as "pain" or "no pain".	One minute after topical anesthesia.
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.	After 2 minutes of topical anesthesia.
Amount of local anesthesia to be given	Counting the number of used local anesthetic carpules.	At the end of dental procedure.
Need for additional analgesics	Count the number and dose of oral analgesics taken by the patient.	Within 48 hours postoperatively.
Reporting of any adverse effects, such as mucosal irritation, allergic reactions, and delayed pain relief.	Reported by the patient.	Within 48 hours postoperatively.

Collaborators and Investigators

• Sponsor: Dubai Health

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: December 8, 2025
• First Submitted That Met QC Criteria: January 27, 2026
• First Posted (Actual): January 30, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Stomatognathic Diseases; Nervous System Diseases; Dental Pulp Diseases; Tooth Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pulpitis; Agnosia; Therapeutics; Laser Therapy; Phototherapy; Low-Level Light Therapy
• Other Study ID Numbers: MBRU IRB-2024-695

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No