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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02084433
Other study ID # 75018
Secondary ID
Status Completed
Phase N/A
First received March 6, 2014
Last updated February 22, 2017
Start date January 2015
Est. completion date February 2017

Study information

Verified date February 2017
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

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

Study Design


Intervention

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 "
conventional anasthesia
para-apical maxillary and locoregional mandibular (Articaine 1/100000) anaesthesia

Locations

Country Name City State
France Hôpital Bretonneau Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

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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