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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034408
Receipt No. R000039234
Official scientific title of the study Pain-free Dental Local Analgesia in Children: Evaluation of the effectiveness of an educational activity
Date of disclosure of the study information 2018/10/11
Last modified on 2018/10/11

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Basic information
Official scientific title of the study Pain-free Dental Local Analgesia in Children: Evaluation of the effectiveness of an educational activity
Title of the study (Brief title) Pain-free Dental Local Analgesia in Children
Region
Asia(except Japan) Europe

Condition
Condition Dental injection pain and dental fear/anxiety
Classification by specialty
Dental medicine Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To improve the postgraduate students' knowledge, skills and attitudes for providing pain-free dental local analgesia in children
Basic objectives2 Others
Basic objectives -Others 1) To improve behavior management skills of the postgraduate students to further develop the cooperation of anxious and fearful child patients 2) To make postgraduate students familiar with local analgesic equipments 3) To corralate the relation of dental anxiety and injection pain also regarding the local analgesic site and technique
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Reductions in pain perception and anxiety scores of children related to dental local analgesia procedures
Key secondary outcomes Improvement of postgraduate dental students' knowledge, skills and attitudes related to pain-free dental local analgesia 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
Other
Interventions/Control_1 Following baseline data collection, postgraduates in the intervention group (n=5) will get additional education aiming improvement in knowledge, skill and attitude to perform pain-free dental local analgesia in children. Each postgraduate will perform 14 infiltration, 8 mandibular block, 8 palatinal injections.
Interventions/Control_2 Following baseline data collection, postgraduates in the control group (n=5) will not get any additional education about pain-free dental local analgesia. Each postgraduate will perform 14 infiltration, 8 mandibular block, 8 palatinal injections.
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
13 years-old >=
Gender Male and Female
Key inclusion criteria Requirement of pain control (local analgesia) due to a dental problem, and willingness to participate in the study
Key exclusion criteria Children
- having no need for pain control (local analgesia) due to a dental problem,
- with systemic and psychological disease,
- referred with acute dental pain
- whose parents are unwilling to participate in the study
Target sample size 300

Research contact person
Name of lead principal investigator Prof.Dr.Serap Akyuz, Res. Asst. Selcuk Mert Ozcelik
Organization Marmara University, School of Dentistry
Division name Pediatric Dentistry Department
Address Marmara University, Dis Hekimligi Fakultesi, Pedodonti Anabilim dali, Basibuyuk Saglik Yerleskesi 9/3, 34854 Maltepe/istanbul/Turkey
TEL +902164211621
Email sakyuz@marmara.edu.tr

Public contact
Name of contact person Assoc.Prof.Dr.Ozgur Onder Kuscu
Organization Istanbul Kent University, School of Dentistry
Division name Pediatric Dentistry Department
Address Cihangir Mahallesi, Siraselviler Caddesi, No:71, 34433 Beyoglu ISTANBUL TURKEY
TEL 90(212)6101010
Homepage URL
Email ookuscu@yahoo.com

Sponsor
Institute Marmara University, School of Dentistry
Pediatric Dentistry Department
Institute
Department

Funding Source
Organization None, researchers will fund by their own
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2018 Year 10 Month 11 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 11 Month 09 Day
Anticipated trial start date
2018 Year 11 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 10 Month 08 Day
Last modified on
2018 Year 10 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039234

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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