Comparison of Osteocentral Versus Locoregional Anesthesia in Case of Mandibular Molar Pulpitis (COQ)
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|ClinicalTrials.gov Identifier: NCT03802305|
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : April 1, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Endodontic Inflammation||Device: computerized intraosseous technique (Quicksleeper™) Device: loco-regional anesthesia (IANB technique)||Not Applicable|
When the patient arrive in the dental care center, an initial assessment is made to get the diagnosis of irreversible pulpitis:
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 Quickslepper™ handpiece but different specific needles.
Each patient receive 1.8 mL of 4% articaine 1:100 000 on a period of 2 minutes.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||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)|
|Official Title:||Comparison of the Variations of the Cardiovascular Parameters and the Efficiency of the Osteocentral Anesthesia (Quicksleeper™) and the Locoregional Anesthesia in the Case of Mandibular Pulpitis|
|Actual Study Start Date :||March 1, 2019|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2020|
Experimental: Computerized intraosseous technique (Quicksleeper™)
patients will receive the anesthetic solution with computerized intraosseous technique anesthesia near the tooth roots involved.
Device: computerized intraosseous technique (Quicksleeper™)
The anesthetic solution is administered with a specific equipment allowing the injection step by step:
Active Comparator: loco-regional anesthesia (IANB technique)
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.
Device: loco-regional anesthesia (IANB technique)
The anesthetic solution is delivered by a needle near to the inferior alveolar nerve before it enters the mandibular foramen.
- time required (in minutes) to re-obtain the baseline cardiovascular parameters like reported before injection: expected event. [ Time Frame: at day 0, from T0 minute to T14 minutes ]
- 3 successive values of heart rate similar to those registered before injection.
- 3 successive values of blood pressure (diastolic and systolic) similar to those registered before injection.
- Compare the pain of the patient between the two anesthetic techniques [ Time Frame: 3 days ]Scores measured with Visual Analog Score( Heft-Parker's pain assessment) (minimum score : no pain ; maximal score : maximum pain unimaginable)
- Compare the possible postoperative course between the 2 anesthetic techniques [ Time Frame: 3 days ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03802305
|Contact: Alexis GAUDIN||+33 2 40 41 29 email@example.com|
|Contact: Tony PRUD'HOMME||+33 6 77 48 96 48||Tony.Prudhomme@univ-nantes.fr|
|Nantes Universitary Hospital||Recruiting|
|Nantes, Loire-Atlantique, France, 44093|
|Contact: Alexis GAUDIN|
|Principal Investigator: Alexis GAUDIN|