Dental Anaesthesia Affects Pain Level

Not Applicable

Completed

• Conditions: Anesthesia, Local; Dental Anxiety
• Interventions: Device: DENTAL LOCAL ANESTHESİA

• Registration Number: NCT05002673
• Lead Sponsor: Karadeniz Technical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-01
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-01
• Study First Submitted: 2021-07-16
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-11
• Last Update Submitted: 2021-08-11
• Study First Posted: 2021-08-12
• Last Update Posted: 2021-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
COMFORTIN	DENTAL LOCAL ANESTHESİA	-
SLEEPERONE	DENTAL LOCAL ANESTHESİA	-

Primary Outcome Measures

Name	Time	Method
level of opiorphin (from saliva samples)	one year
Score of scales (face, legs, activity, cry, consolability)	one year	(0-10) (0= relaxed, 10=severe discomfort)
Score of scales (frankl behavior rating scale)	one year	(1-4) (1= definitely negative, 4=definitely positive)
heart rate (pulse oximeter)	one year
Score of scales (wong baker faces pain rating scale)	one year	(0-10) (0= no hurt, 10= hurts worst)

Trial Locations

Locations (1)

Nagehan Yılmaz; 🇹🇷 Trabzon, None Selected, Turkey