UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036405
Receipt number R000039233
Scientific Title Evaluation of Painfree Local Anesthesia in Children
Date of disclosure of the study information 2020/06/30
Last modified on 2023/09/12 17:28:08

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Basic information

Public title

Painfree Local Anesthesia in Children

Acronym

PaFein

Scientific Title

Evaluation of Painfree Local Anesthesia in Children

Scientific Title:Acronym

Evaluation of Painfree Local Anesthesia (PaFein) in Children

Region

Asia(except Japan) Europe


Condition

Condition

Active research

Classification by specialty

Dental medicine Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To improve the postgraduate students' essential knowledge, skills and attitudes for providing pain-free dental local anesthesia in children

Basic objectives2

Others

Basic objectives -Others

1) To improve postgraduate students' knowledge and skills on behaviour management techniques for better cooperation with anxious and fearful child patients 2) To improve postgraduate students psychomotor and affective skills for providing pain-free dental local anaesthesia 3) To investigate the relation of anxiety and pain regarding local anaesthesia site, technique and other possible related factors

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Reduction in pain and anxiety scores of children during dental local anesthesia procedures

Key secondary outcomes

Improvement of postgraduate dental students' knowledge, skills and attitudes related to pain-free dental local anesthesia techniques in children


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom Maneuver Other

Interventions/Control_1

Following baseline measurements, postgraduate students in the intervention group will get additional education aiming improvements in knowledge, skill and attitude to perform pain-free local dental injections (reductions are anticipated in pain scores) in children. Each postgrad. either in study or control group will administer 30 injections (14 infiltration, 8 mandibular, 8 palatinal) to randomly assigned patients who are in the need of dental injection for their dental treatments.

Interventions/Control_2

Following baseline measurements, postgraduate students in the control group will not get any additional education. Each postgrad. either in study or control group will administer 30 injections (14 infiltration, 8 mandibular, 8 palatinal) to randomly assigned patients who are in the need of dental injection for their dental treatments.

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

5 years-old <

Age-upper limit

14 years-old >

Gender

Male and Female

Key inclusion criteria

Requirement of pain control (dental injection) due to a dental problem.

Key exclusion criteria

No need for pain control (dental injection) due to a dental problem.

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Serap
Middle name
Last name Akyuz

Organization

Marmara University, School of Dentistry

Division name

Pediatric Dentistry

Zip code

34854

Address

Basibuyuk MU Saglik Yerleskesi 9/3 Maltepe Istanbul Turkey

TEL

+902164211621

Email

sakyuz@marmara.edu.tr


Public contact

Name of contact person

1st name Ozgur
Middle name Onder
Last name Kuscu

Organization

Kent University, School of Dentistry

Division name

Pediatric Dentistry

Zip code

34433

Address

Cihangir Mahallesi, Siraselviler Caddesi, No:71, Beyoglu ISTANBUL TURKEY

TEL

+905327690065

Homepage URL


Email

ookuscu@yahoo.com


Sponsor or person

Institute

Marmara University, School of Dentistry, Department of Pediatric Dentistry

Institute

Department

Personal name



Funding Source

Organization

Marmara University, School of Dentistry, Department of Pediatric Dentistry

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Marmara University School of Dentistry Research Ethics Committee

Address

MU Basibuyuk Saglik Yerleskesi 9/3 Maltepe Istanbul Turkey

Tel

0216 421 16 21 (1559)

Email

dhf.etikkurul@marmara.edu.tr


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2020 Year 06 Month 30 Day


Related information

URL releasing protocol

http://upload.umin.ac.jp/rd/rd_e.cgi?t=ic&n=R000039233&k=3002ROmVyZr9zqJAbiwjcknL

Publication of results

Published


Result

URL related to results and publications

https://doi.org/10.1002/jdd.12785, https://doi.org/10.1002/jdd.13120

Number of participants that the trial has enrolled

172

Results

Total VAS Pain Scores (0-10)

Study group: 1,28

Control group: 2,59

P<0,0001



Buccal infiltration anesthesia VAS Pain Scores (0-10)

Study group:1,08

Control group:1,90

p<0,02


Mandibular anesthesia VAS Pain Scores (0-10)

Study group:1,58

Control group:3,37

p<0,0001


Palatinal/Lingual infiltration anesthesia VAS Pain Scores (0-10)

Study group:1,34

Control group: 3,02

p<0,0001

Results date posted

2021 Year 04 Month 04 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Assessed for eligiblity (n=100 children)
Excluded (n=15 children)
- Not meeting inclusion criteria (n=9)
- Declined to participate (n=6)
- Allocated to baseline intervention (n= 85 children)

baseline pain scores of 120 injections: 2,78
pain scores by anaesthesia type:
buccal infiltration (n:60): 2,09
palatal/lingual infiltration(n:30): 3,91
mandibular block (n:30): 3,02

Participant flow

Assessed for eligiblity (n=191 children)
Excluded (n=19 children)
- Not meeting inclusion criteria (n=13)
- Declined to participate (n=6)
- Allocated to randomized intervention (n= 172 children)

Study group:74 children
Control group: 98 children

Adverse events

none

Outcome measures

1) Pain perception of children during dental local anesthesia,
2) Anxiety levels of childen after dental local anesthesia

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 11 Month 12 Day

Date of IRB

2018 Year 04 Month 26 Day

Anticipated trial start date

2019 Year 04 Month 07 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 04 Month 04 Day

Last modified on

2023 Year 09 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039233


Research Plan
Registered date File name
2020/02/27 Research Plan.docx

Research case data specifications
Registered date File name
2020/02/27 Research Case Data Specifications.docx

Research case data
Registered date File name
2020/04/22 UMIN-Final Results.xlsx