Deep Caries, Molar Incisor Hypomineralisation
Conditions
Keywords
MIH of the first permanent molar
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
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.
Interventions
1 / Anesthesia of periosteum (Articaine 1/100000) 2 / penetration of the needle rotated to the apex 3 / osteocentral injection
PROCEDUREconventional anasthesia
para-apical maxillary and locoregional mandibular (Articaine 1/100000) anaesthesia
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 15 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Outcome results
None listed