Unique ID issued by UMIN | UMIN000036405 |
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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 |
Painfree Local Anesthesia in Children
PaFein
Evaluation of Painfree Local Anesthesia in Children
Evaluation of Painfree Local Anesthesia (PaFein) in Children
Asia(except Japan) | Europe |
Active research
Dental medicine | Child |
Others
NO
To improve the postgraduate students' essential knowledge, skills and attitudes for providing pain-free dental local anesthesia in children
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
Exploratory
Explanatory
Not applicable
Reduction in pain and anxiety scores of children during dental local anesthesia procedures
Improvement of postgraduate dental students' knowledge, skills and attitudes related to pain-free dental local anesthesia techniques in children
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
No treatment
2
Educational,Counseling,Training
Behavior,custom | Maneuver | Other |
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.
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.
5 | years-old | < |
14 | years-old | > |
Male and Female
Requirement of pain control (dental injection) due to a dental problem.
No need for pain control (dental injection) due to a dental problem.
300
1st name | Serap |
Middle name | |
Last name | Akyuz |
Marmara University, School of Dentistry
Pediatric Dentistry
34854
Basibuyuk MU Saglik Yerleskesi 9/3 Maltepe Istanbul Turkey
+902164211621
sakyuz@marmara.edu.tr
1st name | Ozgur |
Middle name | Onder |
Last name | Kuscu |
Kent University, School of Dentistry
Pediatric Dentistry
34433
Cihangir Mahallesi, Siraselviler Caddesi, No:71, Beyoglu ISTANBUL TURKEY
+905327690065
ookuscu@yahoo.com
Marmara University, School of Dentistry, Department of Pediatric Dentistry
Marmara University, School of Dentistry, Department of Pediatric Dentistry
Self funding
Marmara University School of Dentistry Research Ethics Committee
MU Basibuyuk Saglik Yerleskesi 9/3 Maltepe Istanbul Turkey
0216 421 16 21 (1559)
dhf.etikkurul@marmara.edu.tr
NO
2020 | Year | 06 | Month | 30 | Day |
http://upload.umin.ac.jp/rd/rd_e.cgi?t=ic&n=R000039233&k=3002ROmVyZr9zqJAbiwjcknL
Published
https://doi.org/10.1002/jdd.12785, https://doi.org/10.1002/jdd.13120
172
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
2021 | Year | 04 | Month | 04 | Day |
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
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
none
1) Pain perception of children during dental local anesthesia,
2) Anxiety levels of childen after dental local anesthesia
Completed
2018 | Year | 11 | Month | 12 | Day |
2018 | Year | 04 | Month | 26 | Day |
2019 | Year | 04 | Month | 07 | Day |
2020 | Year | 03 | Month | 31 | Day |
2019 | Year | 04 | Month | 04 | Day |
2023 | Year | 09 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039233
Research Plan | |
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Registered date | File name |
2020/02/27 | Research Plan.docx |
Research case data specifications | |
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Registered date | File name |
2020/02/27 | Research Case Data Specifications.docx |
Research case data | |
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Registered date | File name |
2020/04/22 | UMIN-Final Results.xlsx |