Dental Anaesthesia Affects Pain Level

Sponsor

Karadeniz Technical University (Other)

Overall Status

Completed

CT.gov ID

NCT05002673

Collaborator

The Scientific and Technological Research Council of Turkey (Other)

Enrollment

Location

Arms

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Anxiety Anesthesia, Local	Device: DENTAL LOCAL ANESTHESİA	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 1, 2020

Actual Primary Completion Date :

Jul 1, 2021

Actual Study Completion Date :

Jul 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SLEEPERONE	Device: DENTAL LOCAL ANESTHESİA doing local and topical anesthesia with two different device
Experimental: COMFORTIN	Device: DENTAL LOCAL ANESTHESİA doing local and topical anesthesia with two different device

Arm

Intervention/Treatment

Experimental: SLEEPERONE

Device: DENTAL LOCAL ANESTHESİA

doing local and topical anesthesia with two different device

Experimental: COMFORTIN

Device: DENTAL LOCAL ANESTHESİA

doing local and topical anesthesia with two different device

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 10 Years

Sexes Eligible for Study:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nagehan Yılmaz	Trabzon	None Selected	Turkey	61080

Sponsors and Collaborators

Karadeniz Technical University
The Scientific and Technological Research Council of Turkey

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nagehan Yilmaz, Assistant Prof, Karadeniz Technical University

ClinicalTrials.gov Identifier:

NCT05002673

Other Study ID Numbers:

Karadeniz

First Posted:

Aug 12, 2021

Last Update Posted:

Aug 12, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Anesthetics

Study Results

No Results Posted as of Aug 12, 2021