Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03802305 |
| Other study ID # |
RC18_0268 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2019 |
| Est. completion date |
June 17, 2022 |
Study information
| Verified date |
June 2022 |
| Source |
Nantes University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The irreversible acute pulpitis is the most common emergency at the hospital during dental
consultation. Pulpitis are characterized by intense and spontaneous oro-facial pains. In case
of mandibular molar, the emergency treatment consists in realizing a pulpotomy (eviction of
cameral pulp) under locoregional anesthesia called inferior alveolar nerve block (IANB). The
latter represents a real challenge, since inflammation may decrease its action. To mitigate
this deficiency and the drawbacks of the IANB (onset and duration of the anesthesia, bites
risk reported with IANB) other anesthesias are proposed. In particular the computerized
intraosseous technique anesthesia of which the Quicksleeper™ system is a part. However,
according to the observers, a mild to severe tachycardia have been reported.
Very few valid clinical trials exists on the subject, most being realized with systems of
intraosseous anesthesia other than Quicksleeper™. Therefore, the aim of this study is first
to analyze the variations of the cardiovascular parameters into two groups of anesthesia:
locoregional anesthesia and Quicksleeper ™ system; and then, to compare the efficiency, side
effects, operating consequences of both techniques. This study should provide better data
about potential risk with computerized intraosseous technique such has Quicksleeper ™ system
in healthy or cardiovascular risk patient.
Description:
When the patient arrive in the dental care center, an initial assessment is made to get the
diagnosis of irreversible pulpitis:
1. Anamnesis:
acute and spontaneous oro-facial pain, pulsatile severe intensity, which could irradiate
toward the ear and/or jaw, exacerbated by cold or hot.
2. Clinical exams: positive vitality tests (electric test and cold pressor test)
3. Further examination (radiography)
The inclusion and exclusion criteria will be checked and the informed consent of the patient
will be taken. The patient is then randomized in one of the group (experimental or control).
He will fill a questionnaire (Corah's scale) for evaluating his state of anxiety during care.
A monitoring of cardiac parameters is made during the care at defined moment.
The patient evaluates his pain himself with the VAS (Visual Analog Score), before the
intervention. The anesthesia is carried out by only one experimenter, with the Quickslepper™
handpiece but different specific needles.
Each patient receive 1.8 mL of 4% articaine 1:100 000 on a period of 2 minutes.
