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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036405
Receipt No. R000039233
Scientific Title Pain-free Dental Local Anesthesia in Children: Evaluation of the effectiveness of an educational activity
Date of disclosure of the study information 2020/06/30
Last modified on 2020/04/09

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Basic information
Public title Pain-free Dental Local Anesthesia in Children
Acronym PafDeLAC
Scientific Title Pain-free Dental Local Anesthesia in Children: Evaluation of the effectiveness of an educational activity
Scientific Title:Acronym PafDeLAC:EEEA
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
Institute Marmara University, School of Dentistry, Department of Pediatric Dentistry
Institute
Department

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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
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
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
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
2020 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.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


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