Comparison of a computer-controlled bone anaesthesia delivery system the versus conventional anaesthesia in child dental patients

ISRCTN	ISRCTN51792136
DOI	https://doi.org/10.1186/ISRCTN51792136
Sponsor	Aristotle University of Thessaloniki
Funder	Aristotle University of Thessaloniki

Submission date: 10/01/2026
Registration date: 14/01/2026
Last edited: 14/01/2026

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Plain English summary of protocol not provided at time of registration.

Contact information

Mrs Anastasia Dermata
Principal investigator, Scientific, Public

Mitropoleos 119, Thessaloniki, Greece
Thessaloniki
54622
Greece

ORCID ID	0000-0002-6631-7161
Phone	6978382505
Email	adermat@dent.auth.gr

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Open (masking not used)
Control	Active
Assignment	Parallel
Purpose	Treatment
Scientific title	Comparison of computer controlled intraosseous anaesthesia and conventional anaesthesia in paediatric dental patients. A randomised controlled trial
Study objectives	This is a randomised controlled split-mouth comparison of the efficacy, acceptance and preference of computer-controlled intraosseous anaesthesia and conventional local anesthesia for paediatric dental patients.
Ethics approval(s)	Approved 01/10/2020, Bio-Ethics Committee of the School of Dentistry, Aristotle University of Thessaloniki, Greece (Aristotle University of Thessaloniki GR 54124, Thessaloniki Greece, Thessaloniki, 54124, Greece; +32310999652; econom@dent.auth.gr), ref: 93/01-10-2020
Health condition(s) or problem(s) studied	Comparison of the efficacy, acceptance and preference of computer controlled intraosseous anaesthesia and conventional local anesthesia for paediatric dental patients.
Intervention	Healthy children aged 5-9 years old requiring similar treatment in both sides of the upper or the lower jaw are recruited in the Paediatric Dentistry Department of Dental School of Aristotle University of Thessaloniki, Greece, and randomized with split- mouth design to intraosseous anesthesia with Quicksleeper 5® (Dental HiTec, Cholet, France) on one side and conventional local anesthesia to the other side, with one week between them. The side as well as the order of administration are randomly assigned. A single experienced paediatric dentist is applying both methods and data collection. Patients are asked questions to assess their acceptance/preference for the two methods. Data are analyzed statistically with linear/logistic regressions at alpha=5%.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Efficacy, acceptance and preference, child cooperation measured using the Frankl scale for child cooperation, treatment completion recorded as completed or not completed, acceptance and preference were assessed using questionnaires at during anaesthetic administration, immediately after administration, on a third appointment after a week from the last administration
Key secondary outcome measure(s)
Completion date	28/09/2024

Eligibility

Participant type(s)
Age group	Child
Lower age limit	5 Years
Upper age limit	9 Years
Sex	All
Target sample size at registration	61
Total final enrolment	64
Key inclusion criteria	1. Healthy children aged 5-9 years 2. Cooperative children, Frankl scale 3 or 4 3. Patients should require two bilateral similar dental treatments in homologous teeth 4. Patient should require one third treatment requiring dental anaesthesia
Key exclusion criteria	1. Unhealthy 2. Uncooperative (Frankl 1 or 2) 3. Not eligible for split-mouth design
Date of first enrolment	20/06/2023
Date of final enrolment	28/09/2024

Locations

Countries of recruitment

Greece

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan

Editorial Notes

14/01/2026: The contact email was amended.
12/01/2026: Study’s existence confirmed by the Aristotle University of Thessaloniki School of Dentistry Bio-Ethics Committee, Greece.