Dental Anaesthesia Affects Pain Level | NCT05002673

Studies
Dental Anaesthesia Affects Pain Level

NCT05002673

Sponsor

Karadeniz Technical University

Status

Completed

Last Update Posted

Aug 12, 2021Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Dental Anxiety
Anesthesia, Local

Interventions

DENTAL LOCAL ANESTHESİA

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2020Actual

Primary Completion Date

Jul 1, 2021Actual

Completion Date

Jul 1, 2021Actual

First Submitted Date

Jul 16, 2021

First Submission Date that Met QC Criteria

Aug 11, 2021

First Posted Date

Aug 12, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 11, 2021

Last Update Posted Date

Aug 12, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nagehan Yilmaz, Assistant Prof, Karadeniz Technical UniversityPrincipal Investigator

Lead Sponsor

Karadeniz Technical UniversityOTHER

Collaborators

Name	Class
The Scientific and Technological Research Council of Turkey	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SLEEPERONE	Experimental		Device: DENTAL LOCAL ANESTHESİA
COMFORTIN	Experimental		Device: DENTAL LOCAL ANESTHESİA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DENTAL LOCAL ANESTHESİA	Device	doing local and topical anesthesia with two different device	COMFORTIN SLEEPERONE

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nagehan Yılmaz		Trabzon	None Selected	61080	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided