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OpenTrials
Completed

NCT Number: NCT02084433

Comparison of Intraosseous Anaesthesia Using a Computerized System (QuickSleeper) to Conventional Anesthesia

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intraosseous anaesthesia using a computerized system

Procedure

"1 / Anesthesia of periosteum (Articaine 1/100000) 2 / penetration of the needle rotated to the apex 3 / osteocentral injection "

conventional anasthesia

Procedure

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

Primary outcomes

  1. Pain reported by the patient according to the visual analogue scale (VAS)

    Time frame: 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 outcomes

  1. latency

    Time frame: 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)

  2. need for additional anesthesia during the treatment

    Time frame: 1 hour

  3. pain felt during the treatment

    Time frame: 1 hour

    need for additional anesthesia during the treatment; pain felt during the treatment evaluated at the end of treatment according to the VAS

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: QUICK

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 12, 2014
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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