Dental Anaesthesia Affects Pain Level

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05002673

Enrollment

Registered

2021-08-12

Start date

2020-07-01

Completion date

2021-07-01

Last updated

2021-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Local, Dental Anxiety

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.

Interventions

DEVICEDENTAL LOCAL ANESTHESİA

doing local and topical anesthesia with two different device

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

8 Years to 10 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Score of scales (wong baker faces pain rating scale)	one year	(0-10) (0= no hurt, 10= hurts worst)
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	—
level of opiorphin (from saliva samples)	one year	—

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026