Pain Clinical Trial
Official title:
Comparative Evaluation of Pain Perception With a New Needle-Free System and Dental Injection in Children: A Randomized Clinical Trial
Verified date | December 2020 |
Source | Tokat Gaziosmanpasa University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate and compare the pain perception associated with a needle-free injection system( Comfort-In) and dental injection method in filling and pulpotomy treatments
Status | Completed |
Enrollment | 56 |
Est. completion date | August 5, 2019 |
Est. primary completion date | August 5, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 4 Years to 11 Years |
Eligibility | Inclusion Criteria: - Aged between 4-11 years - Having no developmental or systemic disorder or no history of allergy - Having "positive" or "definitely positive" cooperation level according to the Frankl Behavior Scale - Having sufficient mouth opening - Operation only on primary teeth - Having decayed teeth that require anesthesia Exclusion Criteria: - Patients younger than five years, older than 11 years, - Patients with systemic or developmental disorders - Children with an allergy history - 'Negative' or 'definitly negative' behavior rating according to the Frankl scale - Patients whose mouth opening is not sufficient for dental treatment - Operating only on permanent teeth - Teeth that are beyond the treatment stage - When pain occurred during treatment, supplemental anesthetics administrated, and these children were excluded. |
Country | Name | City | State |
---|---|---|---|
Turkey | Tokat Gaziosmanpasa University, Faculty of Dentistry | Tokat | Center |
Lead Sponsor | Collaborator |
---|---|
Tokat Gaziosmanpasa University |
Turkey,
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* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain at different anesthesia methods | The pain perception scores in the two anesthesia methods were assessed with Wong-Baker Pain Scale (Wong-Baker Scale is pain assessment method.It consists of 6 facial expressions that are evaluated from 0 to 10 according to the severity of the pain.) | after dental treatments to 24 hour |
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