Determination of the Effect of Two Different Methods of Dental Anaesthesia on Pain Level in Paediatric Patients: A Cross-over, Randomised Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- level of opiorphin (from saliva samples)
Study Overview
Brief Summary
Background: Needles are the most feared tools, making anaesthetic injection a worrying practice.
Aim: To compare intraosseous (IOA) and needle-free dental anaesthesia (NFA) methods that painless anaesthesia.
Design: Twenty patients aged 8-10 years were included in this cross-over study. To determine the anxiety levels and pain experienced by the patients, visual and behavior scales were used. The pulse rate (PR) and opiorphin levels (OL) determined. The Friedman and Wilcoxon signed-rank tests were used. p<0.05 was considered significant.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 8 Years to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients aged 8-10 years,
- •systemically healthy,
- •had undergone dental treatment (except for extraction) previously but with at least 1 week passed since then
- •were compatible enough to undergo therapy in the clinic in a sitting position,
- •had infection between the roots with a rate over 1/3, had 2/3 root formation,
- •had been indicated for extraction of the maxillary primary molar teeth (55/65 No. teeth),
- •did not have acute and/or subacute infection of the related or other teeth or mouth and surrounding tissues
Exclusion Criteria
- •who scored above 41 in the state anxiety subscale and above 44 in the trait anxiety subscale of the Spielberger State-Trait Anxiety Scale (SSAS-SAAS)
- •not meeting the inclusion criteria
Arms & Interventions
COMFORTIN
Intervention: DENTAL LOCAL ANESTHESİA (Device)
SLEEPERONE
Intervention: DENTAL LOCAL ANESTHESİA (Device)
Outcomes
Primary Outcomes
level of opiorphin (from saliva samples)
Time Frame: one year
Score of scales (face, legs, activity, cry, consolability)
Time Frame: one year
(0-10) (0= relaxed, 10=severe discomfort)
Score of scales (frankl behavior rating scale)
Time Frame: one year
(1-4) (1= definitely negative, 4=definitely positive)
heart rate (pulse oximeter)
Time Frame: one year
Score of scales (wong baker faces pain rating scale)
Time Frame: one year
(0-10) (0= no hurt, 10= hurts worst)
Secondary Outcomes
No secondary outcomes reported
Investigators
Nagehan Yilmaz
Assistant Prof
Karadeniz Technical University