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

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ClinicalTrials.gov Identifier: NCT03953001
Recruitment Status : Completed
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Jehan AlHumaid, 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.

Condition or disease Intervention/treatment Phase
Local Anaesthetic Dental Anxiety Device: Adminstration Technique using Buzzy external distractor Drug: 2% Lidocaine with 1:50,000 epinephrine Drug: Topical Anesthetic Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of a Vibration System on Pain Reduction During Injection of Local Dental Anaesthesia in Children: a Randomized Controlled Clinical Trial
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : April 1, 2018
Actual Study Completion Date : June 1, 2018

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

Drug: Topical Anesthetic
20% Benzocaine gel was applied on the area of infiltration

Active Comparator: Control
Maxillary anesthetic infiltration injection with 2%lidocaine with 1:50,000 epinephrine after topical application with 20% Benzocaine topical gel only.
Drug: 2% Lidocaine with 1:50,000 epinephrine
Local Dental anesthetic infiltration

Drug: Topical Anesthetic
20% Benzocaine gel was applied on the area of infiltration




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03953001


Locations
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Saudi Arabia
imam adbulrahman Bin Faisal University- College of Dentistry
Dammam, Saudi Arabia, 32412
Sponsors and Collaborators
Imam Abdulrahman Bin Faisal University
Investigators
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Principal Investigator: Jehan A AlHumaid, DSc imam Abdulrahman Bin Faisal

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Responsible Party: Jehan AlHumaid, Associate Professor, Imam Abdulrahman Bin Faisal University
ClinicalTrials.gov Identifier: NCT03953001     History of Changes
Other Study ID Numbers: JH123456
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lidocaine
Benzocaine
Anesthetics
Epinephrine
Racepinephrine
Epinephryl borate
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents