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

Dental Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03953001
• Other study ID #: JH123456
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: June 1, 2018

Study information

• Verified date: May 2019
• Source: Imam Abdulrahman Bin Faisal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: June 1, 2018
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Anxiety
• Local Anaesthetic

Intervention

Device:
• Adminstration Technique using Buzzy external distractor
External application of Buzzy distractor during administration of dental anesthetic

Drug:
• 2% Lidocaine with 1:50,000 epinephrine
Local Dental anesthetic infiltration
• Topical Anesthetic
20% Benzocaine gel was applied on the area of infiltration

Locations

Country	Name	City	State
Saudi Arabia	imam adbulrahman Bin Faisal University- College of Dentistry	Dammam

Sponsors (1)

Lead Sponsor	Collaborator
Imam Abdulrahman Bin Faisal University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self Reported pain intensity: Visual analogue scale (VAS) of pain intensity	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).	Procedure (immediately after the administration of Dental anesthesia)
Secondary	Parents Perception for the child tolerance of pain; Observational Pain rating scale	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)	Procedure (immediately after the administration of Dental anesthesia.)
Secondary	External observation for Facial and Physical expression. Using Sounds, Eyes, and Motor (SEM) scale (RANGE 0-9).	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.	Procedure (immediately during and after the administration of Dental anesthesia.)
Secondary	Faces Legs Activity Cry Consolability (FLACC) Scale (RANGE 0-10)	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.	Procedure (immediately during and after the administration of Dental anesthesia.)