drugset / Trial / NCT06804616

Pain Reduction Using Vibration and Topical Anesthesia

NCT06804616

Phase 0 Completed 60 enrolled University of Lahore
RandomizedParallel-groupSingle-blindPrevention

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.

Timeline

Start
2024-11-28
Primary completion
2024-12-30
Completion
2025-02-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Benzocaine Small molecule 20 % Topical

Indications

No indication recorded.