PulpitisNCT07379515
Effects of Topical Anesthesia Approaches on Dental Pain During and After Restorative Management of Dental Caries
A study testing Photobiomodulation (PBM)-induced analgesia device using multi-wavelength LED and Medicated analgesia in people with Pulpitis and Pain Management, run by Dubai Health.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Pulpitis, Pain Management
- What is being tested?
- Photobiomodulation (PBM)-induced analgesia device using multi-wavelength LED and Medicated analgesia
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- acetaminophen
- Recent oral trauma
- Deep carious lesion with irreversible pulpitis or pulpal necrosis
About this study
Official title: 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:
Read more
- 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.
- Intervention: Participants would be randomly assigned to different groups based on the type or method of topical anesthesia being tested.
- Treatment Procedure: Dental caries management would be performed under local anesthesia, with the designated topical anesthetic applied beforehand.
- Pain Assessment: Participants would rate their pain levels during and after the procedure using validated pain measurement scales (e.g., visual analog scale).
- 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.
- Conditions
- Pulpitis, Pain Management
- Being tested
- Photobiomodulation (PBM)-induced analgesia device using multi-wavelength LED, Medicated analgesia, Placebo
- Medical subject headings
- Pulpitis, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation (PBM)-induced analgesia device using multi-wavelength LEDDevice
Photobiomodulation (PBM)-induced analgesia device using multi-wavelength LED
Medicated analgesiaOther
Topical anesthesia (Benzocaine 20%)
PlaceboOther
Placebo with no intervention.
| Study group | Role | What they receive |
|---|---|---|
| Non-medicated anelgesia | Experimental | Not described Receives: Device: Photobiomodulation (PBM)-induced analgesia device using multi-wavelength LED |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
| Medicated anelgesia | Active comparator | Not described Receives: Other: Medicated analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Pain score will be reported as "pain" or "no pain".
Measured: 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.
Measured: After 2 minutes of topical anesthesia.
Amount of local anesthesia to be given
Counting the number of used local anesthetic carpules.
Measured: At the end of dental procedure.
Need for additional analgesics
Count the number and dose of oral analgesics taken by the patient.
Measured: Within 48 hours postoperatively.
Reporting of any adverse effects, such as mucosal irritation, allergic reactions, and delayed pain relief.
Reported by the patient.
Measured: Within 48 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start15 Apr 2026 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PulpitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dubai Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sameeha Husain Al Marzooqi, Dubai Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07379515
- Sponsor's protocol ID
- MBRU IRB-2024-695
- Status last verified
- Apr 2026
- First submitted
- 8 Dec 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Topical Anesthesia Approaches on Dental Pain During and After Restorative Management of Dental Caries - Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07379515
- Acronym / sponsor ID
- MBRU IRB-2024-695
- Conditions
- Pulpitis, Pain Management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Dubai HealthOther government
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Intervention: Participants would be randomly assigned to different groups based on the type or method of topical anesthesia being tested.
- Treatment Procedure: Dental caries management would be performed under local anesthesia, with the designated topical anesthetic applied beforehand.
- Pain Assessment: Participants would rate their pain levels during and after the procedure using validated pain measurement scales (e.g., visual analog scale).
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-medicated anelgesia | Experimental | Device: Photobiomodulation (PBM)-induced analgesia device using multi-wavelength LED |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
| Medicated anelgesia | Active comparator | Other: Medicated analgesia |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photobiomodulation (PBM)-induced analgesia device using multi-wavelength LEDPhotobiomodulation (PBM)-induced analgesia device using multi-wavelength LED | Device | Non-medicated anelgesia |
| Medicated analgesiaTopical anesthesia (Benzocaine 20%) | Other | Medicated anelgesia |
| PlaceboPlacebo with no intervention. | Other | Placebo |
Primary outcome
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.
5 secondary outcomes
Pain score with prick pain test (PPT)
Time frame: One minute after topical anesthesia.
Pain score with pulpal stimulation using electric pulp tester (EPT)
Time frame: After 2 minutes of topical anesthesia.
Amount of local anesthesia to be given
Time frame: At the end of dental procedure.
Need for additional analgesics
Time frame: Within 48 hours postoperatively.
Reporting of any adverse effects, such as mucosal irritation, allergic reactions, and delayed pain relief.
Time frame: Within 48 hours postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation (PBM)-induced analgesia device using multi-wavelength LED and Medicated analgesia in people with Pulpitis and Pain Management, run by Dubai Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.