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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of Osteocentral Versus Locoregional Anesthesia in Case of Mandibular Molar Pulpitis

NCT03802305

Endodontic Inflammation

COMPLETED NA

Efficacy of Computer Controlled Intraosseous Anesthesia in Pediatric Dental Patients

NCT06245161

Irreversible Pulpitis Tooth Extraction

UNKNOWN NA

Effect of Intrapulpal Injections on the Post-endodontic Pain

NCT06088446

Pulpitis - Irreversible

COMPLETED NA

Intraosseous Local Anesthesia System in Children With Molar Incisor Hypomineralization

NCT06461143

Molar Incisor Hypomineralization Hypersensitivity Composite Restoration

SUSPENDED NA

Intraosseus Injection Using Extra-short Needle Combined With Infiltration in Pediatric Patients With Molar Incisor Hypomineralization

NCT07239050

Molar Hypomineralization

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Deep Caries Molar Incisor Hypomineralisation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

conventional anasthesia

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

Group Type ACTIVE_COMPARATOR

conventional anasthesia

Intervention Type PROCEDURE

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

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 "

Group Type EXPERIMENTAL

intraosseous anaesthesia using a computerized system

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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 "

Intervention Type PROCEDURE

conventional anasthesia

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

7 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes