ClinicalTrials.gg
Not yet recruitingNCT07379515Updated Apr 13, 2026

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

An interventional study of Photobiomodulation (PBM)-induced analgesia device using multi-wavelength LED and Medicated analgesia in Pulpitis and Pain Management, sponsored by Dubai Health. Not yet recruiting. Open to participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2026-04-13.

Sponsored by Dubai Health · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
204
Allocation
Randomized
Ages
18 Years to 59 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Pulpitis
  • Pain Management

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03

In context

Pulpitis

316 studies on the registry are indexed under Pulpitis; 90 are open to participants now.

This study's planned enrollment of 204 is above the median of 64 across 288 interventional studies indexed under Pulpitis.

Browse Pulpitis studies →

Lead sponsor

Dubai Health is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 included in the vial
  • Participant requiring caries management for a maxillary premolar tooth (ICDAS I-V), with reversible pulpitis.

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
204 participants (estimated)

Study arms

  • Experimental
    Non-medicated anelgesia

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

  • Placebo comparator
    Placebo

    Placebo

    Other: Placebo

  • Active comparator
    Medicated anelgesia

    Other: Medicated analgesia

Interventions

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

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

  • OtherMedicated analgesia

    Topical anesthesia (Benzocaine 20%)

  • OtherPlacebo

    Placebo with no intervention.

06

What researchers measure

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.

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

    Reported by the patient.

    Time frame: Within 48 hours postoperatively.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07379515
Lead sponsor
Dubai Health
Responsible party
Sameeha Husain Al Marzooqi (Consultant, Dubai Health) — Principal investigator
First posted
Jan 30, 2026
Start date
Apr 15, 2026 (estimated)
Primary completion
Jul 31, 2026 (estimated)
Completion
Mar 31, 2027 (estimated)
Last update
Apr 13, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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