Comparison between a needle-free system (Comfort-In) and needle dental anaesthesia in adult volunteers
Not Applicable
Completed
- Conditions
- Method of dental anaesthesiaOral Health
- Registration Number
- ISRCTN17400733
- Lead Sponsor
- Aristotle University of Thessaloniki
- Brief Summary
2021 results in https://pubmed.ncbi.nlm.nih.gov/33912990/ (added 30/04/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 63
Inclusion Criteria
1. Healthy adults, aged 19 - 40 years
2. History of previous dental anaesthesia
3. Present upper premolars with vital pulp tissue
Exclusion Criteria
1. History of dental phobia or any other phobia
2. History of drug or substance abuse
3. Upper premolars with restorations/caries
4. Pregnant women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Measured at 3, 5, 10, 15, 20, 25 and 30 minutes (unless otherwise noted):<br> 1. Pulp vitality measured using electric pulp test (Pulppen DP2000 Digital, Dental Electronic)<br> 2. Pulp sensitivity measured using the cold test (ethyl chloride spray)<br> 3. Soft tissue pain measured using the reaction test (pinch via a pair of forceps)<br> 4. Acceptance during the session and preference at the end of the session, at 24 hours and at 7 days were measured via questionnaires<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Length of subjective feeling of numbness was self-reported by volunteers at 24 hours<br> 2. Adverse events were self-reported by volunteers at 24 hours and at 7 days<br>