UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055217 |
|---|---|
| Receipt number | R000063051 |
| Scientific Title | Effectiveness of Oral Hygiene Instructions to Improve Plaque and Gingival Indices: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2024/08/10 |
| Last modified on | 2024/08/10 22:33:41 |
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Basic information
Public title
Effectiveness of Oral Hygiene Instructions to Improve Plaque and Gingival Indices: A Randomized Controlled Trial
Acronym
EOOHITIPAGIARCT
Scientific Title
Effectiveness of Oral Hygiene Instructions to Improve Plaque and Gingival Indices: A Randomized Controlled Trial
Scientific Title:Acronym
Effectiveness of Oral Hygiene Instructions to Improve Plaque and Gingival Indices: A Randomized Controlled Trial
Region
| Asia(except Japan) |
Condition
Condition
Effectiveness of Oral Hygiene Instructions to Improve Plaque and Gingival Indices: A Randomized Controlled Trial
Classification by specialty
| Dental medicine | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the current study was to evaluate the effectiveness of individual oral hygiene instructions in improving the plaque and gingival indices in children. Individual oral hygiene instructions were compared with an addition of a home task.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
differences between IOHIHT and IOHI groups in plaque and gingival indices
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
participants were divided into two groups: one group was informed to take a daily photo of their teeth after nighttime brushing and then send it to their parents as a home task. If no photo was sent, the parent will send a reminder. This group was referred to as Individual Oral Hygiene Instruction with Home Task (IOHIHT).
Interventions/Control_2
On the other hand, the other group received only individual Oral Hygiene Instructions (IOHI) with no further action
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
| 8 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
all paediatric patients admitted to dental clinic
- Age (8-12 years).
- The pediatric subject can take a photo of their teeth and send it to their parents with comments.
- No physical or mental limitations to perform the assigned home task (taking photos of their teeth).
- No history of antibiotic use within the past 3 weeks.
- No medical condition affecting the gingival health.
- No history of comprehensive dental rehabilitation under general anesthesia.
Key exclusion criteria
- The pediatric subject can Not take a photo of their teeth and send it to their parents with comments.
- physical or mental limitations to perform the assigned home task (taking photos of their teeth).
- history of antibiotic use within the past 3 weeks.
- medical condition affecting the gingival health.
- history of comprehensive dental rehabilitation under general anesthesia.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Abdullah |
| Middle name | A |
| Last name | Marghalani |
Organization
preventive dentistry department, Umm Al-Qura University
Division name
preventive dentistry department
Zip code
24382
Address
Abidiyyah (Mecca), Aziziyah (Mecca), Al-Zahir (Mecca), Al-Lith, Al-Qundufah, Jamoom
TEL
+966125270000
aamarghalani@uqu.edu.sa
Public contact
Name of contact person
| 1st name | Marwa |
| Middle name | M |
| Last name | Alhothali |
Organization
Security Forces Hospital-Makkah
Division name
paediatric dental department
Zip code
24251
Address
2514 Taif Road 6838,Al Mashair 2514 6838 Makkah 24251
TEL
0125278888
Homepage URL
malhuthali@sfhm.med.sa
Sponsor or person
Institute
Security Forces Hospital-Makkah
Institute
Department
Personal name
Funding Source
Organization
none
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
Security Forces Hospital-Makkah
Address
2514 Taif Road 6838 Al Mashair 2514 - 6838, Makkah 24251
Tel
012 527 8888
info@sfhm.med.sa
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
| 2024 | Year | 08 | Month | 10 | Day |
Related information
URL releasing protocol
https://1drv.ms/w/c/051eee0c54d12ca5/EYilvAWu8zVHmcLK_G8ngywBI4BSh1eXahjQLJThjUT__g
Publication of results
Unpublished
Result
URL related to results and publications
https://1drv.ms/w/c/051eee0c54d12ca5/EYilvAWu8zVHmcLK_G8ngywBI4BSh1eXahjQLJThjUT__g
Number of participants that the trial has enrolled
22
Results
For the baseline-post comparison, the IOHIHT group showed a significantly lower plaque index in the follow-up visitFor the baseline-post comparison when gingival index was measured, it also was significantly reduced in the IOHIHT group
Results date posted
| 2024 | Year | 08 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
At baseline, about 7 (63.6%) of all subjects brushed their teeth two times or more daily. At baseline, the plaque index (P = 0.92) and gingival index (P = 0.67) were comparable between the intervention groups
Participant flow
A total of 11 subjects completed the study. There was one subject lost to follow-up and was excluded from the analysis. There were 5 (45.5%) boys in the IOHIHT group and 5 (45.5%) boys in the IOHI group.
Adverse events
none
Outcome measures
lower plaque index and gingival index reduction in the IOHIHT group
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 10 | Day |
Last modified on
| 2024 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063051
