Deep Caries Clinical Trial
— QUICKOfficial title:
Comparison of Intraosseous Anaesthesia Using a Computerized System (QuickSleeper) to Conventional Anesthesia
Verified date | February 2017 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 158 |
Est. completion date | February 2017 |
Est. primary completion date | February 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 7 Years to 15 Years |
Eligibility |
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 - patient did not take any pain medication 48 hours before randomization - non-opposition of the child and two holders of parental participation in the study - Treatments can be conservative treatment or endodontic treatment limited to pulpotomy. Exclusion Criteria: - Patients with periodontal disease (periodontal pockets or tooth mobility) or radiological defects (necrosis, furcation or periapical radiolucency) - Disabled or autistic patients - Patients with cancer, heart disease or sickle cell anemia |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Bretonneau | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain reported by the patient according to the visual analogue scale (VAS) | 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 | up to 10 minutes | |
Secondary | latency | 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) | up to 15 minutes | |
Secondary | need for additional anesthesia during the treatment | 1 hour | ||
Secondary | pain felt during the treatment | need for additional anesthesia during the treatment; pain felt during the treatment evaluated at the end of treatment according to the VAS | 1 hour |
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