Status:
WITHDRAWN
Effectiveness of Synapse Transcutaneous Electronic Nerve Stimulation (TENS) During Dental Procedures Among Children
Lead Sponsor:
Boston University
Conditions:
Dental Fear
Anesthesia, Local
Eligibility:
All Genders
6-14 years
Phase:
NA
Brief Summary
Dental Fear and Anxiety (DFA) are at higher levels among children and often leads to avoidance of dental treatment. Negative experiences in the early years such as experience of pain during injections...
Detailed Description
Children between 6-14 years will be recruited at the Pediatric Oral Healthcare Center. A sample of 100 male and female children who fit the inclusion and exclusion criteria are recruited. Once parents...
Eligibility Criteria
Inclusion
- Children who are healthy and without any major medical conditions
- Children who are patients at the Pediatric Oral Healthcare Center
- Children requiring restoration on the occlusal surface that involves tooth preparation up to the dentin level in at least two primary or permanent molars or children requiring extractions of primary or permanent molars.
- Children who are scheduled for at least two appointments and who require two restorative procedures or two extractions than can be scheduled over two separate appointments
Exclusion
- Children who have contraindications to local anesthetic
- Children with teeth requiring restoration and have pulp involvement and root resorption on radiological examination (i.e. deep caries)
- Children who have major medical problems
- Children taking medications for major medical illnesses
- Children who have pacemakers
- Children with ADD/ADHD, autism or Down's syndrome and children with a history of behavioral issues that required previous management.
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03779659
Start Date
July 1 2021
End Date
February 1 2023
Last Update
June 8 2021
Active Locations (1)
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1
BU Henry M. Goldman School of Dental Medicine
Boston, Massachusetts, United States, 02118