Pain Reduction Using Vibration and Topical Anesthesia

NCT06804616 | Completed Early Phase 1 FDA Drug FDA Device

• 1 other identifier: UCD/ERCA/24/1108
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain Management

Keywords

Pediatric Dentistry; Pain Management; Local Anesthesia; Benzocaine Gel; Powered Toothbrush; SEM Scale; Wong-Baker Pain Scale; Pain Reduction Techniques; Randomized Control Trial

Outcome Measures

Primary Outcomes (2)

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

  Evaluation of objective pain responses during local anesthesia administration using the SEM scale. Scores range from 0 (no pain) to 9 (severe pain).

  "During the intervention, within 5 minutes"

• Pain Levels as Assessed by Wong-Baker FACES Pain Scale

  Self-reported subjective pain levels assessed by the Wong-Baker FACES scale, ranging from 0 (no hurt) to 10 (hurts worst).

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

Study Arms (2)

Topical Anesthesia Group (20% Benzocaine Gel)

ACTIVE COMPARATOR

Participants in this group will receive 20% Benzocaine Gel applied topically to the injection site for 5 minutes before administering local anesthesia. Pain levels will be assessed using both subjective (Wong-Baker FACES Pain Scale) and objective (SEM Scale) measures.

Drug: 20% benzocaine Gel

Vibration Group (Powered Toothbrush)

EXPERIMENTAL

Participants in this group will receive vibratory stimulation using a powered toothbrush applied to the injection site for a minimum of one minute before administering local anesthesia. Pain levels will be assessed using both subjective (Wong-Baker FACES Pain Scale) and objective (SEM Scale) measures.

Device: Powered Toothbrush

Interventions

20% benzocaine Gel DRUG

Participants in this group received 20% Benzocaine Gel applied to the injection site for 5 minutes prior to local anesthesia administration. The gel acts as a topical anesthetic to numb the area and reduce pain perception during the injection procedure.

Also known as: Oral Anesthetic Gel, Benzocaine Oral Gel, Hurricaine Gel

Topical Anesthesia Group (20% Benzocaine Gel)

Powered Toothbrush DEVICE

Participants in this group received vibration stimulation using a powered toothbrush applied to the injection site for 1 minute before the local anesthesia injection. The vibration works on the principle of gate control theory, aiming to disrupt pain signals and reduce discomfort during the injection procedure.

Also known as: Oral-B Powered Toothbrush, Vibrating Toothbrush, Electric Toothbrush

Vibration Group (Powered Toothbrush)

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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."

You may not qualify if:

• Intellectually impaired/Autistic
• Patient allergic to L.A
• Patient with systemic health condition

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

University Of Lahore

Lahore, Punjab Province, 53700, Pakistan

Location

Related Publications (4)

• AlHareky M, AlHumaid J, Bedi S, El Tantawi M, AlGahtani M, AlYousef Y. Effect of a Vibration System on Pain Reduction during Injection of Dental Anesthesia in Children: A Randomized Clinical Trial. Int J Dent. 2021 Jan 30;2021:8896408. doi: 10.1155/2021/8896408. eCollection 2021.

  PMID: 33564311 BACKGROUND

• Shilpapriya M, Jayanthi M, Reddy VN, Sakthivel R, Selvaraju G, Vijayakumar P. Effectiveness of new vibration delivery system on pain associated with injection of local anesthesia in children. J Indian Soc Pedod Prev Dent. 2015 Jul-Sep;33(3):173-6. doi: 10.4103/0970-4388.160343.

  PMID: 26156269 BACKGROUND

• Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965 Nov 19;150(3699):971-9. doi: 10.1126/science.150.3699.971. No abstract available.

  PMID: 5320816 BACKGROUND

• Shaefer JR, Lee SJ, Anderson NK. A Vibration Device to Control Injection Discomfort. Compend Contin Educ Dent. 2017 Jun;38(6):e5-e8.

  PMID: 28586233 BACKGROUND

Related Links

• Vibrating toothbrush, ice, or topical anesthetic agent to reduce pain of local anesthetic injection in 5- to 12-year-old children undergoing dental procedures - a randomized controlled trial
• Comparison of Three Different Techniques to Allay Anxiety before Local Anesthesia Injection in Pediatric Population

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Irsam Haider, BDS, MCPS

  University of Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: February 3, 2025
• Study Start: November 28, 2024
• Primary Completion: December 30, 2024
• Study Completion: February 3, 2025
• Last Updated: April 2, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)