Endodontic Inflammation Clinical Trial
— COQOfficial 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
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 |
Verified date | June 2022 |
Source | Nantes University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 72 |
Est. completion date | June 17, 2022 |
Est. primary completion date | June 17, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - real irreversible pulpitis of a mandibular molar in dental emergency consultation at the Nantes hospital - Healthy patient without medical history (ASA 1), without treatment for heart rate distress (anti arrhythmic, beta-blocking drug) - Major and covered by the social security - Informed consent 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 - Pheochromocytomas - Bisphosphonate IV - Irradiated patient (upper respiratory and gastrointestinal tract cancer) - Contraindication with Mono-amino oxidase inhibitors - 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 |
Country | Name | City | State |
---|---|---|---|
France | Nantes Universitary Hospital | Nantes | Loire-Atlantique |
Lead Sponsor | Collaborator |
---|---|
Nantes University Hospital |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | time required (in minutes) to re-obtain the baseline cardiovascular parameters like reported before injection: expected event. | 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. |
at day 0, from T0 minute to T14 minutes | |
Secondary | 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 | |
Secondary | Compare the possible postoperative course between the 2 anesthetic techniques | 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 |
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