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

Not Applicable

Completed

• Conditions: Local Anaesthetic; Dental Anxiety
• Interventions: Device: Adminstration Technique using Buzzy external distractor; Drug: Topical Anesthetic

• Registration Number: NCT03953001
• Lead Sponsor: Imam Abdulrahman Bin Faisal University

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.

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2018-04-01
• Study Completion: 2018-06-01
• Study First Submitted: 2019-03-29
• Status Verified: 2019-05
• Study First Submitted QC: 2019-05-15
• Last Update Submitted: 2019-05-15
• Study First Posted: 2019-05-16
• Last Update Posted: 2019-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Buzzy	Adminstration Technique using Buzzy external distractor	Buzzy was used during Maxillary anesthetic infiltration injection with 2%lidocaine with 1:50,000 epinephrine after topical application with 20% Benzocaine topical gel.
Buzzy	Topical Anesthetic	Buzzy was used during Maxillary anesthetic infiltration injection with 2%lidocaine with 1:50,000 epinephrine after topical application with 20% Benzocaine topical gel.
Control	Topical Anesthetic	Maxillary anesthetic infiltration injection with 2%lidocaine with 1:50,000 epinephrine after topical application with 20% Benzocaine topical gel only.

Primary Outcome Measures

Name	Time	Method
Self Reported pain intensity: Visual analogue scale (VAS) of pain intensity	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 Outcome Measures

Name	Time	Method
Parents Perception for the child tolerance of pain; Observational Pain rating scale	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)
External observation for Facial and Physical expression. Using Sounds, Eyes, and Motor (SEM) scale (RANGE 0-9).	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.
Faces Legs Activity Cry Consolability (FLACC) Scale (RANGE 0-10)	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.

Trial Locations

Locations (1)

imam adbulrahman Bin Faisal University- College of Dentistry; 🇸🇦 Dammam, Saudi Arabia