Clinical trial NCT03953001: Effect of a Vibration System on Pain Reduction During Injection of Local Dental Anaesthesia in Children
Official title: Effect of a Vibration System on Pain Reduction During Injection of Local Dental Anaesthesia in Children: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Local Anaesthetic
Dental Anxiety
Lead sponsor: Imam Abdulrahman Bin Faisal University
Sponsor class: OTHER
First posted: 2019-05-16
Enrollment: 51
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Self Reported pain intensity: Visual analogue scale (VAS) of pain intensity
timeFrame: Procedure (immediately after the administration of Dental anesthesia)
Secondary outcomes:
measure: Parents Perception for the child tolerance of pain; Observational Pain rating scale
timeFrame: Procedure (immediately after the administration of Dental anesthesia.)
measure: External observation for Facial and Physical expression. Using Sounds, Eyes, and Motor (SEM) scale (RANGE 0-9).
timeFrame: Procedure (immediately during and after the administration of Dental anesthesia.)
measure: Faces Legs Activity Cry Consolability (FLACC) Scale (RANGE 0-10)
timeFrame: Procedure (immediately during and after the administration of Dental anesthesia.)
Other outcomes:
Locations:
city: Dammam
country: Saudi Arabia
facility: imam adbulrahman Bin Faisal University- College of Dentistry
Study officials:
affiliation: imam Abdulrahman Bin Faisal
name: Jehan A AlHumaid, DSc
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.