QUICK: Comparison of Intraosseous Anaesthesia Using a Computerized System (QuickSleeper) to Conventional Anesthesia
Study Details
Study Description
Brief Summary
The purpose is to compare the efficacy of an intraosseous anaesthesia using a computerized system (QuickSleeper) to a conventional infiltration anesthesia. Our hypothesis is that anesthesia via QuickSleeper system can reduce pain during anesthesia and obtain a more rapid local anesthesia compared to the anesthesia via conventional technique by infiltration.
Design: split-mouth design AND parallel-arm design
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Local anesthesia is commonly used in oral health care and intra-mucosal infiltration anesthesia is most commonly used by practitioners. Anesthesia may cause children a great deal of anxiety because of the fear of the injection. The latter can be painful if the product is delivered too quickly in the mucosa. Recent developments in the techniques and anesthesia systems allow reducing pain during the injection. In particular, computerized systems (electronically assisted local anesthesia) allow a slow injection limiting pressure. Moreover, these systems look like a pen which prevents the negative impression of the image related to the syringe metal. The intraosseous electronically-assisted anesthesia could be an interesting alternative to conventional infiltration anesthesia by making the act less stressful but also less painful for the child.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: conventional anasthesia para-apical maxillary and locoregional mandibular (Articaine 1/100000) anaesthesia |
Procedure: conventional anasthesia
para-apical maxillary and locoregional mandibular (Articaine 1/100000) anaesthesia
|
| Experimental: intraosseous anaesthesia intraosseous anaesthesia using a computerized system (Quicksleeper) "1 / Anesthesia of periosteum (Articaine 1/100000) 2 / penetration of the needle rotated to the apex 3 / osteocentral injection " |
Procedure: intraosseous anaesthesia using a computerized system
"1 / Anesthesia of periosteum (Articaine 1/100000) 2 / penetration of the needle rotated to the apex 3 / osteocentral injection "
|
Outcome Measures
Primary Outcome Measures
- Pain reported by the patient according to the visual analogue scale (VAS) [up to 10 minutes]
Pain reported by the patient according to the visual analogue scale (VAS) will be evaluated at the end of the injection / infiltration. The assessment will concern the insertion of the needle and the injection / infiltration
Secondary Outcome Measures
- latency [up to 15 minutes]
latency (in minutes) evaluated by examining the sensitivity of the sulcus using a probe (an exam will be conducted every minute until the sulcus is insensitive to the probe)
- need for additional anesthesia during the treatment [1 hour]
- pain felt during the treatment [1 hour]
need for additional anesthesia during the treatment; pain felt during the treatment evaluated at the end of treatment according to the VAS
Eligibility Criteria
Criteria
Inclusion Criteria:
-
split-mouth randomized controlled trial: patients with at least two first permanent molars requiring the same treatment with anesthesia
-
parallel-arm radnomized controlled trial: patients with first permanent molar requiring treatment with anesthesia
-
vital pulp
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patient did not take any pain medication 48 hours before randomization
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non-opposition of the child and two holders of parental participation in the study
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Treatments can be conservative treatment or endodontic treatment limited to pulpotomy.
Exclusion Criteria:
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Patients with periodontal disease (periodontal pockets or tooth mobility) or radiological defects (necrosis, furcation or periapical radiolucency)
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Disabled or autistic patients
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Patients with cancer, heart disease or sickle cell anemia
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hôpital Bretonneau | Paris | France | 75018 |
Sponsors and Collaborators
- Assistance Publique - Hôpitaux de Paris
Investigators
- Principal Investigator: Frédéric Courson, PhD, Assistance Publique - Hôpitaux de Paris
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 75018