Clinical trial NCT02675387: Efficacy of External Cold and a Vibrating Device in Reducing Discomfort of Dental Injections in Children
Official title: Efficacy of External Cold and a Vibrating Device in Reducing Discomfort of Dental Injections in Children - A Split Mouth Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Lead sponsor: Riyadh Colleges of Dentistry and Pharmacy
Sponsor class: OTHER
First posted: 2016-02-05
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Children in their seventh year of life (age range of 6 to 7 years) will be included in the study. All children included in the study would have to classified according to the Wright behavior classification as potentially co-operative and rated as per the Frankl behavior rating scale as positive (++) Group A and negative (-) Group B . All children included must have had no prior experience of dental anesthesia and must have at least one tooth requiring restorative procedure on either side of the maxillary arch. Intervention Description

1. Regular Anesthesia All the subjects received local anesthesia injection in maxillary arch as is commonly practiced in dental clinics. Information obtained before assignment of intervention or standard care included age, gender, type of injection given alongside the vibration device will be recorded beforehand. During the delivery of anesthesia for all the groups, anticipated and actual pain will be recorded to show the impact of anxiety on the experience of participants. During the entire process, all participants will use standard needles with confirmed specification to control for any potential confounders
2. Buzzy® The use of the external cold and a vibrating Device will follow the manufacturer's recommendations to ensure that normal clinical scenario is created.

Detailed description: Methodology Ethical Clearance:The study will be registered at the clinical trials registry of the United States National Institutes of Health (NIH), following which ethical approval will be obtained from the institutional review board of the Riyadh Colleges of Dentistry and Pharmacy Patient Recruitment The sample will comprise of 60 children reporting to the clinics of the Riyadh Colleges of Dentistry and Pharmacy determine to have treatment that involve the use of local anesthesia.

Sample Power Calculation Sample power calculation was done using the G Power sample size calculator (Universtat Kiel, Kiel, Germany) . Given the split mouth study design proposed a high effect size of 0.8 was assumed. The minimum number of individuals for an alpha of 0.05 and a power of 0,95 was 19 subjects per group. Given the risk of attrition of subjects in the study, the total sample size recruited will be 30 per group (n=60)

The Inclusion Criteria Children in their seventh year of life (age range of 6 to 7 years) will be included in the study. All children included in the study would have to classified according to the Wright behavior classification as potentially co-operative and rated as per the Frankl behavior rating scale as positive (++) Group A and negative (-) Group B . All children included must have had no prior experience of dental anesthesia and must have at least one tooth requiring restorative procedure on either side of the maxillary arch. The classification of each patient will be done separately by two experienced pediatric dentists (NG and SCP) and consensus on the classification will be obtained before including the patient in the study. Informed consent will be obtained from the parent of all patients who agree to participate in the study.

Exclusion Criteria Patients with a history of hospitalization or surgery, those with chronic illness will be excluded from the study. The study will also exclude patients diagnosed with neurobehavioral disorders such as autism, ADHD or learning disability. Patients with congenital syndromes or intellectual disability will also be excluded from the study.

Intervention Description

1. Regular Anesthesia All the subjects received local anesthesia injection in maxillary arch as is commonly practiced in dental clinics. Information obtained before assignment of intervention or standard care included age, gender, type of injection given alongside the vibration device will be recorded beforehand. During the delivery of anesthesia for all the groups, anticipated and actual pain will be recorded to show the impact of anxiety on the experience of participants. During the entire process, all participants will use standard needles with confirmed specification to control for any potential confounders
2. Buzzy® The use of the external cold and a vibrating Device will follow the manufacturer's recommendations to ensure that normal clinical scenario is created.

Eligibility criteria: Inclusion Criteria:

* No prior experience of dental anesthesia
* At least one upper tooth on either side requiring anesthesia before restoration

Exclusion Criteria:

* History of mental illness
* Extensive hospitalization for chronic illness
* Past history of surgery

Primary outcomes:
measure: Pain of injection ( Wong Baker Face Pain Scale)
timeFrame: 0 min - at the time of injection
measure: Pain of injection ( Wong Baker Face Pain Scale)
timeFrame: 5 min after the injection
measure: Pain of injection ( Wong Baker Face Pain Scale)
timeFrame: 30 min after the injection
Secondary outcomes:
measure: Behavior ( Frankl behavior rating scale)
timeFrame: 5min before procedure, 5 min after completion of procedure
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Riyadh Colleges of Dentistry and Pharmacy
state: Al Riyadh
Study officials:
affiliation: Riyadh Colleges of Dentistry and Pharmacy
name: Sharat C Pani
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Roeber B, Wallace DP, Rothe V, Salama F, Allen KD. Evaluation of the effects of the VibraJect attachment on pain in children receiving local anesthesia. Pediatr Dent. 2011 Jan-Feb;33(1):46-50.
citation: Whelan HM, Kunselman AR, Thomas NJ, Moore J, Tamburro RF. The impact of a locally applied vibrating device on outpatient venipuncture in children. Clin Pediatr (Phila). 2014 Oct;53(12):1189-95. doi: 10.1177/0009922814538494. Epub 2014 Jun 12.
citation: Wiederhold MD, Gao K, Wiederhold BK. Clinical use of virtual reality distraction system to reduce anxiety and pain in dental procedures. Cyberpsychol Behav Soc Netw. 2014 Jun;17(6):359-65. doi: 10.1089/cyber.2014.0203.
citation: Alanazi KJ, Pani S, AlGhanim N. Efficacy of external cold and a vibrating device in reducing discomfort of dental injections in children: A split mouth randomised crossover study. Eur Arch Paediatr Dent. 2019 Apr;20(2):79-84. doi: 10.1007/s40368-018-0399-8. Epub 2018 Dec 5.