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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-59
SponsorDubai Health

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

American Society of Anesthesiology Class III or higher

Participants with systemic conditions affecting pain perception

Participants on chronic pain medication

Pregnant or breastfeeding women

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Device

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

  • Medicated analgesia

    Other intervention

    Topical anesthesia (Benzocaine 20%)

  • Placebo

    Other intervention

    Placebo with no intervention.

Treatment groups

204 Participants
are divided into 3 treatment groups
Group A: Non-medicated anelgesiaExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Group C: Medicated anelgesiaActive comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Pain score with prick pain test (PPT)

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

Time frame
One minute after topical anesthesia.
2

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.

Time frame
After 2 minutes of topical anesthesia.
3

Amount of local anesthesia to be given

Counting the number of used local anesthetic carpules.

Time frame
At the end of dental procedure.
4

Need for additional analgesics

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

Time frame
Within 48 hours postoperatively.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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