Skip to content

Comparison between a needle-free system (Comfort-In) and needle dental anaesthesia in adult volunteers

Comparison of efficacy, acceptance and preference between Comfort-In local anaesthetic device and conventional infiltration technique in adult volunteers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17400733
Enrollment
63
Registered
2021-01-18
Start date
2019-03-30
Completion date
Unknown
Last updated
2021-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Method of dental anaesthesia Oral Health

Interventions

Upper premolars without any restorations or caries and with vital pulp tissue were chosen to be anaesthetized. One technique was applied on the right side whilst the other on the left side sequentiall

Sponsors

Aristotle University of Thessaloniki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Measured at 3, 5, 10, 15, 20, 25 and 30 minutes (unless otherwise noted): 1. Pulp vitality measured using electric pulp test (Pulppen DP2000 Digital, Dental Electronic) 2. Pulp sensitivity measured using the cold test (ethyl chloride spray) 3. Soft tissue pain measured using the reaction test (pinch via a pair of forceps) 4. Acceptance during the session and preference at the end of the session, at 24 hours and at 7 days were measured via questionnaires

Secondary

MeasureTime frame
1. Length of subjective feeling of numbness was self-reported by volunteers at 24 hours 2. Adverse events were self-reported by volunteers at 24 hours and at 7 days

Countries

Greece

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 23, 2026