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NCT Number: NCT03953001

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

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.

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Key information

Conditions

Local Anaesthetic Dental Anxiety

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

imam adbulrahman Bin Faisal University- College of Dentistry

Dammam, 32412, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Adminstration Technique using Buzzy external distractor

Device

External application of Buzzy distractor during administration of dental anesthetic

2% Lidocaine with 1:50,000 epinephrine

Drug

Local Dental anesthetic infiltration

Topical anesthetic

Drug

20% Benzocaine gel was applied on the area of infiltration

Primary outcomes

  1. Self Reported pain intensity: Visual analogue scale (VAS) of pain intensity

    Time frame: Procedure (immediately after the administration of Dental anesthesia)

    Self reported pain intensity before the injection and directly after the injection. Each child scored pain intensity twice, one before the injection and one directly after the injection (0=no pain; 10=Very painful).

Secondary outcomes

  1. Parents Perception for the child tolerance of pain; Observational Pain rating scale

    Time frame: Procedure (immediately after the administration of Dental anesthesia.)

    The parents were asked about the reaction and attitude of the child during the dental anesthesia administration. Parents rated the child ability to tolerate pain with (0=Didn't Tolerate and 10= Tolerated with a smile)

  2. External observation for Facial and Physical expression. Using Sounds, Eyes, and Motor (SEM) scale (RANGE 0-9).

    Time frame: Procedure (immediately during and after the administration of Dental anesthesia.)

    Video was recorded for each child before, during and after the administration of local anesthesia. Each video was assessed by an external calibrated evaluator to score each child response. SEM (0=Comfortable, with no sound, no eye signs of discomfort and Hands are relaxed, no apparent body tenseness, 9= Painful, with verbal complain, crying tears and moving the hands to make aggressive physical contact and pulling the head away. The lowest record mean the child was comfortable and the higher the score mean the child experienced discomfort.

  3. Faces Legs Activity Cry Consolability (FLACC) Scale (RANGE 0-10)

    Time frame: Procedure (immediately during and after the administration of Dental anesthesia.)

    Video was recorded for each child before, during and after the administration of local anesthesia. Each video was assessed by an external calibrated evaluator to score each child response. FLACC (0=The child did not express any facial discomfort with normal legs position no abnormal activity, not crying and relaxed. The highest score 10= Child experienced discomfort, moving his legs jerking crying and difficult to console. The lowest record mean the child was comfortable and the higher the score mean the child experienced discomfort.

Sponsors and collaborators

Lead sponsor

Imam Abdulrahman Bin Faisal University

Other

Registry information

Official study title

Effect of a Vibration System on Pain Reduction During Injection of Local Dental Anaesthesia in Children: a Randomized Controlled Clinical Trial

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 16, 2019
Registry last updated
May 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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