NCT02084433

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 12, 2014

Completed
10 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

2.1 years

First QC Date

March 6, 2014

Last Update Submit

February 22, 2017

Conditions

Deep CariesMolar Incisor Hypomineralisation

Keywords

MIH of the first permanent molar

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • latency

    up to 15 minutes

  • need for additional anesthesia during the treatment

    1 hour

  • pain felt during the treatment

    1 hour

Study Arms (2)

conventional anasthesia

ACTIVE COMPARATOR

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

Procedure: conventional anasthesia

intraosseous anaesthesia

EXPERIMENTAL

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 "

Procedure: intraosseous anaesthesia using a computerized system

Interventions

intraosseous anaesthesia using a computerized systemPROCEDURE

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

intraosseous anaesthesia
conventional anasthesiaPROCEDURE

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

conventional anasthesia

Eligibility Criteria

Age7 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Bretonneau

Paris, 75018, France

Location

Related Publications (2)

  • Smail-Faugeron V, Muller-Bolla M, Sixou JL, Courson F. Evaluation of intraosseous computerized injection system (QuickSleeper) vs conventional infiltration anaesthesia in paediatric oral health care: A multicentre, single-blind, combined split-mouth and parallel-arm randomized controlled trial. Int J Paediatr Dent. 2019 Sep;29(5):573-584. doi: 10.1111/ipd.12494. Epub 2019 Apr 8.

    PMID: 30883951DERIVED

  • Smail-Faugeron V, Muller-Bolla M, Sixou JL, Courson F. Split-mouth and parallel-arm trials to compare pain with intraosseous anaesthesia delivered by the computerised Quicksleeper system and conventional infiltration anaesthesia in paediatric oral healthcare: protocol for a randomised controlled trial. BMJ Open. 2015 Jul 10;5(7):e007724. doi: 10.1136/bmjopen-2015-007724.

    PMID: 26163031DERIVED

MeSH Terms

Conditions

Molar Hypomineralization

Condition Hierarchy (Ancestors)

Dental Enamel HypomineralizationDevelopmental Defects of EnamelTooth AbnormalitiesStomatognathic System AbnormalitiesStomatognathic DiseasesTooth DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Frédéric Courson, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor, hospital practitionner

Study Record Dates

First Submitted

March 6, 2014

First Posted

March 12, 2014

Study Start

January 1, 2015

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

FR(1)