Dental Anaesthesia Affects Pain Level

Anesthesia, Local Clinical Trial

Official title:

Determination of the Effect of Two Different Methods of Dental Anaesthesia on Pain Level in Paediatric Patients: A Cross-over, Randomised Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05002673
• Other study ID #: Karadeniz
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: July 1, 2021

Study information

• Verified date: August 2021
• Source: Karadeniz Technical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Local
• Dental Anxiety

Intervention

Device:
• DENTAL LOCAL ANESTHESIA
doing local and topical anesthesia with two different device

Locations

Country	Name	City	State
Turkey	Nagehan Yilmaz	Trabzon	None Selected

Sponsors (2)

Lead Sponsor	Collaborator
Karadeniz Technical University	The Scientific and Technological Research Council of Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

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