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NCT Number: NCT07379515

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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

Medicated analgesia

Other

Topical anesthesia (Benzocaine 20%)

Placebo

Other

Placebo with no intervention.

Primary outcomes

  1. Pain score after local anesthesia administration, dental procedure, and 48 hours postoperatively.

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

    Pain score based on Visual Analog Scale (1-10) with highest score indicates the most severe pain.

Secondary outcomes

  1. Pain score with prick pain test (PPT)

    Time frame: One minute after topical anesthesia.

    Pain score will be reported as "pain" or "no pain".

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

    Time frame: After 2 minutes of topical anesthesia.

    Digital reading from 1 to 64 with the highest score indicates no pain response on electric stimulation.

  3. Amount of local anesthesia to be given

    Time frame: At the end of dental procedure.

    Counting the number of used local anesthetic carpules.

  4. Need for additional analgesics

    Time frame: Within 48 hours postoperatively.

    Count the number and dose of oral analgesics taken by the patient.

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

    Time frame: Within 48 hours postoperatively.

    Reported by the patient.

Sponsors and collaborators

Lead sponsor

Dubai Health

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 30, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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