Effects of Topical Anesthesia Approaches on Dental Pain During and After Restorative Management of Dental Caries
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Photobiomodulation (PBM)-induced analgesia device using multi-wavelength LED, Medicated analgesia, Placebo.
- Who it may be relevant to
- Registry conditions: Pulpitis, Pain Management. Basic parameters: 18 years — 59 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Topical Anesthesia Approaches on Dental Pain During and After Restorative Management of Dental Caries - Randomized Clinical Trial
Overview
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.
Interventions
- Device Photobiomodulation (PBM)-induced analgesia device using multi-wavelength LED
Photobiomodulation (PBM)-induced analgesia device using multi-wavelength LED - Other Medicated analgesia
Topical anesthesia (Benzocaine 20%) - Other Placebo
Placebo with no intervention.
Primary outcome measures
- 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.]
Secondary outcome measures (5)
- 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07379515 · MBRU IRB-2024-695