Clinical trial NCT06804616: Pain Reduction Using Vibration and Topical Anesthesia
Official title: Comparison of Mucosal Vibration and Benzocaine Gel in Reducing Pain During Administration of Local Anesthesia in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
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
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2025-02-03
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Pain management during the administration of local anesthesia in pediatric dental patients is one of the biggest challenges in clinical practice. Pain experience can cause dental anxiety, behavioral management problems, and avoidance of necessary dental care in children. This is a randomized controlled trial of two different methods by which to diminish the perception of pain from injections of local anesthetics, namely, by the use of 20% benzocaine topical gel as a pharmacological measure and by employing a powered toothbrush as a non-pharmacological distraction technique. Investigation of these methods will provide information on their practicality and usefulness in pediatric dental environments.

Study Purpose and Rationale The overall objective of this study is to explore strategies that make dental procedures less distressing for children, ensuring better compliance, reduced anxiety, and an overall improved patient experience. Pain perception in pediatric patients is influenced by both physiological and psychological factors. Although pharmacological interventions such as benzocaine are commonly used to numb the tissue before the injection of local anesthesia, they do not deal with the anxiety or behavioral discomfort that is often associated with the injection process. In contrast, distraction techniques, especially those that incorporate vibration, can change the pain perception by breaking the transmission of pain signals and shifting the child's attention to other things.

A particularly needed contribution in the research area is therefore directly comparing the approach adopted by one or more local anaesthetics versus the benzocaine model. Although well documented in many studies about their numbing capability, the present research did not fill an important gap of comparison and competition between using the simple distraction of a vibration-powered toothbrush to reduce or prevent this severe pain upon visiting the orthodontist without much need of such a type of drug treatment or its pharmaceutical cost.

Study Design Overview

This is a randomized controlled trial. Eligible pediatric patients requiring local anesthesia for dental treatment are assigned to one of two intervention groups:

Group A (Topical Anesthetic Group): Patients in this group receive 20% benzocaine gel applied to the injection site for five minutes before the administration of local anesthesia.

Group B (Vibration Group): This group receives vibrational stimulation in the form of a powered toothbrush that is rubbed against the injection site for one minute before receiving local anesthesia.

The computerized-based randomization distributes participants evenly into the two groups to eliminate selection bias and provide an excellent comparison between interventions.

Tools of Pain Measurement

This study makes use of two valid tools that assess the patient's pain perception:

SEM Scale: This is an observational tool that is used to measure pain-related behaviors during the injection process. It measures the child's vocal responses (sound), eye movements, and motor reactions, providing a composite score that reflects their pain-related behavior.

Wong-Baker FACES Pain Scale: This self-report measure is taken as the child assesses the severity of pain that occurred after receiving the injection. A series of images of facial expressions representing "no pain" through "worst pain" are used, which children then assign a number score.

The above two tools integrate to capture both objective and subjective measurements of pain; therefore, a comprehensive analysis is achieved by evaluating the effectiveness of each intervention.

Intervention Procedures Each intervention is administered immediately before the injection of local anesthesia (2% lidocaine with epinephrine). The procedures are standardized and carried out by a single trained dentist to ensure consistency across participants. This approach minimizes variability and ensures that the outcomes accurately reflect the differences between the interventions.

Study Population and Inclusion Criteria Participants are pediatric patients aged 6 to 12 years requiring local anesthesia for dental procedures.

Patients categorized as ASA Class I, i.e., patients who are healthy. No allergic history of the patient to topical anesthetics and any other materials used in this study.

Patient behavior was graded as positive or definitely positive based on the Frankl Behavior Rating Scale (3 and 4 scores).

Exclusion criteria include systemic complications, severe dental anxiety or phobia, or active oral/systemic infections. These criteria ensure the safety of participants and the reliability of the study results.

Ethical Considerations The study follows the principles of the Declaration of Helsinki and is approved by the appropriate institutional ethics review board. Informed consent is sought from the parents or guardians of all participants.

Significance of the Study This trial is of great significance to pediatric dental practice. If this powered toothbrush is proven as effective as benzocaine gel in pain perception, it will be a cheap, non-invasive alternative to pharmacological agents, especially where such agents may not be easily accessible. Besides, the method of distraction addresses the physical and psychological aspects of pain, thus decreasing dental anxiety and improving compliance with the patient.

By basing evidence on recommendations from this study, improving quality care is hoped to provide a more quality life for these children and promote innovation in applying the patient-friendlier method of techniques at clinical levels.

Data Analysis: Statistical analyses will be performed to compare pain scores between the two groups. Descriptive statistics will summarize demographic and baseline characteristics, while inferential tests such as t-tests or ANOVA will assess differences in SEM and Wong-Baker scale scores.

Eligibility criteria: 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

Primary outcomes:
measure: Measure Title: Pain Levels as Assessed by SEM (Sound, Eye, Motor) Scale
timeFrame: "During the intervention, within 5 minutes"
measure: Pain Levels as Assessed by Wong-Baker FACES Pain Scale
timeFrame: "Immediately after the intervention, within 1-5 minutes"
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: University Of Lahore
state: Punjab
Study officials:
affiliation: University of Lahore
name: Irsam Haider, BDS, MCPS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Shaefer JR, Lee SJ, Anderson NK. A Vibration Device to Control Injection Discomfort. Compend Contin Educ Dent. 2017 Jun;38(6):e5-e8.