Effect of a Vibration System on Pain Reduction During Injection of Local Dental Anaesthesia in Children

Imam Abdulrahman Bin Faisal University

Status: Completed

Conditions: Dental Anxiety; Local Anaesthetic

Treatments: Device: Adminstration Technique using Buzzy external distractor; Drug: 2% Lidocaine with 1:50,000 epinephrine; Drug: Topical Anesthetic

Study type: Interventional

Funder types: Other

Identifiers

NCT03953001

JH123456

Details and patient eligibility

About

The study assesses the effect of a new vibration system on pain reduction during the injection of local anesthesia. Children undergoing dental treatment are allocated to two groups; one receiving the Buzz, a vibration system and another group receiving nothing. Pain during injection of local anesthetic is assessed using a validated tool in addition to assessment of child cooperation during treatment.

Full description

Eligibility of children for inclusion into the study will be assessed followed by random sequence generation and randomization into one of the two study group and allocation concealment. Topical anaesthesia will be administered to the two groups followed by implementation of the vibration system in the test group. . Behavior and pain will assessed at the time of injection.

Enrollment: 51 patients

Sex: All

Ages: 5 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Children 5-12 years of age.
2. Positive or definitely positive behavior on Frankl scale.6
3. Children receiving treatment on the dental chair.
4. Free from allergies to topical anesthetic used in the study.
5. Parental consent for child participation in the study.

Exclusion criteria

1. Those in need of treatment under general anesthesia will be excluded from the study.
2. Children with allergies from topical anesthesia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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51 participants in 2 patient groups

Buzzy

Experimental group

Description:

Buzzy was used during Maxillary anesthetic infiltration injection with 2%lidocaine with 1:50,000 epinephrine after topical application with 20% Benzocaine topical gel.

Treatment:

Drug: 2% Lidocaine with 1:50,000 epinephrine

Device: Adminstration Technique using Buzzy external distractor

Drug: Topical Anesthetic

Control

Active Comparator group

Description:

Maxillary anesthetic infiltration injection with 2%lidocaine with 1:50,000 epinephrine after topical application with 20% Benzocaine topical gel only.

Treatment:

Drug: 2% Lidocaine with 1:50,000 epinephrine

Drug: Topical Anesthetic