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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 Quicksleeperâ„¢ 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 Quicksleeperâ„¢. 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 â„¢ 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 â„¢ system in healthy or cardiovascular risk patient.
When the patient arrive in the dental care center, an initial assessment is made to get the diagnosis of irreversible pulpitis:
Anamnesis:
acute and spontaneous oro-facial pain, pulsatile severe intensity, which could irradiate toward the ear and/or jaw, exacerbated by cold or hot.
Clinical exams: positive vitality tests (electric test and cold pressor test)
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 Quickslepperâ„¢ handpiece but different specific needles.
Each patient receive 1.8 mL of 4% articaine 1:100 000 on a period of 2 minutes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Computerized intraosseous technique (Quicksleeperâ„¢) | Experimental | patients will receive the anesthetic solution with computerized intraosseous technique anesthesia near the tooth roots involved. |
|
| loco-regional anesthesia (IANB technique) | Active Comparator | patients will receive the anesthetic solution with the loco-regional anesthesia technique: near the place where the nerve goes into the jaw, based on osteo muscular markers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| computerized intraosseous technique (Quicksleeperâ„¢) | Device | The anesthetic solution is administered with a specific equipment allowing the injection step by step:
|
| Measure | Description | Time Frame |
|---|---|---|
| time required (in minutes) to re-obtain the baseline cardiovascular parameters like reported before injection: expected event. |
| at day 0, from T0 minute to T14 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the pain of the patient between the two anesthetic techniques | Scores measured with Visual Analog Score( Heft-Parker's pain assessment) (minimum score : no pain ; maximal score : maximum pain unimaginable) | 3 days |
| Compare the possible postoperative course between the 2 anesthetic techniques |
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Inclusion Criteria:
Exclusion Criteria:
ASA > 1
Pregnant and breastfeeding women
Minors
Adults under guardianships
Adults deprived of freedom
Impossibility to obtain for informed consent
Allergy to anesthetic components
Contraindication of vasoconstrictor
Angle closure glaucoma
Acute apical periodontitis
Pulpitis on wisdom teeth
Vital teeth with fixed prosthesis
Active periodontal disease
Local anatomic difficulty
No reference tooth for vitality dental test
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nantes Universitary Hospital | Nantes | Loire-Atlantique | 44093 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37209243 | Derived | Gaudin A, Clouet R, Boeffard C, Laham A, Martin H, Amador Del Valle G, Enkel B, Prud'homme T. Comparing intraosseous computerized anaesthesia with inferior alveolar nerve block in the treatment of symptomatic irreversible pulpitis: A randomized controlled trial. Int Endod J. 2023 Aug;56(8):922-931. doi: 10.1111/iej.13935. Epub 2023 May 29. | |
| 36471427 |
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| ID | Term |
|---|---|
| D011671 | Pulpitis |
| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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Number of Arms: 2 Masking: Simple Blinded, Masked Roles: Subject Allocation: Randomized Study Endpoint Classification: Interventional Research with Minimal Risk and Constraints, Safety/Efficacy Enrollment: subjects (anticipated)
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|
| loco-regional anesthesia (IANB technique) | Device | The anesthetic solution is delivered by a needle near to the inferior alveolar nerve before it enters the mandibular foramen. |
|
The postoperative course will be evaluated using a post-operative table to be completed by the patient at Day + 1, Day + 2 and Day + 3. Collection of information by phone call to the patient. The presence or absence of the following item is measured : pain after waking up, swelling, hematoma, seepage, higher tooth sensation, bite, possibility of feeding, mouth opening limitation. |
| 3 days |
| Laham A, Clouet R, Del Valle GA, Gaudin A, Prud'homme T. Anaesthetic efficacy and influence on cardiovascular parameters change of intraosseous computerised anaesthesia versus inferior alveolar nerve block anaesthesia in acute irreversible pulpitis of mandibular molars: study protocol for a prospective randomised controlled trial. Trials. 2022 Dec 5;23(1):979. doi: 10.1186/s13063-022-06915-4. |