CompletedEarly Phase 1

Pain Reduction Using Vibration and Topical Anesthesia

Pakistan60 participantsStarted 2024-11-28

Plain-language summary

The goal of this clinical trial is to study if a powered toothbrush providing vibrations compared with 20% benzocaine topical gel is more effective in reducing pain before local anesthetic injections in children aged 6-12 years undergoing dental procedures. The main questions it aims to answer are: Does the powered toothbrush reduce pain more effectively than the 20% benzocaine topical gel? How do children perceive and respond to each method using subjective and objective pain measurement tools? Researchers will compare the use of a powered toothbrush to 20% benzocaine topical gel to see which method minimizes pain during infiltration anesthesia in pediatric patients. Participants will: Be divided into two groups: Group A: Receive 20% benzocaine topical gel before injection. Group B: Use a powered toothbrush at the injection site before administration. Report pain levels using the Wong-Baker FACES Pain Scale and have their pain responses measured using the SEM Scale. Study Details: Randomized clinical trial with convenience sampling. Inclusion criteria: Children aged 6-12 years, ASA I classification, and positive Frankl behavior rating. Exclusion criteria: Intellectual impairments, allergies to local anesthesia, or systemic health conditions. Study duration: \[November 2024 to December 2024\]. Ethical Considerations: Participation is voluntary, with informed consent required. Responses will remain confidential, and all ethical guidelines will be followed.

Who can participate

Age range

6 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Children aged 6-12 years. * Children classified as ASA I (American Society of Anesthesiologists). * Children with FRANKL Behavior Rating Scale of "positive" or "definitely positive." Exclusion Criteria: * Intellectually impaired/Autistic * Patient allergic to L.A * Patient with systemic health condition

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Measure Title: Pain Levels as Assessed by SEM (Sound, Eye, Motor) Scale

Timeframe: "During the intervention, within 5 minutes"

Pain Levels as Assessed by Wong-Baker FACES Pain Scale

Timeframe: "Immediately after the intervention, within 1-5 minutes"

Trial details

NCT IDNCT06804616

SponsorUniversity of Lahore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-30

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