Status:
COMPLETED
Effectiveness of DentalVibe in Reducing Injection Pain and Anxiety During Local Anaesthesia in Children
Lead Sponsor:
Plovdiv Medical University
Conditions:
Pain Management
Local Anaesthesia
Eligibility:
All Genders
8-12 years
Phase:
NA
Brief Summary
The aim of this study is to determine the effectiveness of DentalVibe (DV) in reducing injection pain and anxiety associated with local anaesthesia in paediatric patients. The clinical trial is a ran...
Detailed Description
Achieving local anaesthesia in children is one of the critical aspects of pain management. In recent years, several innovative dental appliances have been developed on the concept to reduce the pain ...
Eligibility Criteria
Inclusion
- Exclusion criteria:
- Children who are considered medically compromised or medically complex patients. The absence of disease is confirmed by anamnestic interview with a parent or a care-giver of the child and excludes general acute or chronic disease, cognitive impairment, psychogenic nonepileptic events.
- Patients who are undergoing therapy with neurological, sedative, analgesic and/or anti-inflammatory drugs 7 days prior to treatment.
- Patients with allergy to local anesthetics of the amide group.
- Children, who are first time ever dental patients.
- Inclusion criteria:
- Patients, identified as positive or definitely positive through Frankl behavioral rating scale.
- Children, requiring local anaesthesia infiltration for extraction of two primary upper jaw molars bilaterally.
- Indications for extraction of primary molars: over-retention - in case of delayed physiological change and tendency of eruption of the permanent tooth; orthodontic reasons - tooth removed to prevent or correct malocclusion; advanced root resorption and imminent physiological tooth replacement; teeth with a severely damaged clinical crown (from trauma or caries and its complications); teeth with failed pulpotomy, acute or chronic diffuse periodontitis, endangering the germ of the permanent tooth.
- Obtained informed consent from parents or gave-givers to participate in the study.
Exclusion
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 10 2019
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT03445182
Start Date
April 1 2018
End Date
September 10 2019
Last Update
June 4 2021
Active Locations (1)
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1
Faculty of Dental Medicine, Medical University - Plovdiv
Plovdiv, Bulgaria, 4000