UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053118 |
|---|---|
| Receipt number | R000060606 |
| Scientific Title | Factors Influencing the Retention Rate of Resin Based Pit and Fissure Sealant Among Primary School Children- A Randomized Clinical Trail |
| Date of disclosure of the study information | 2023/12/15 |
| Last modified on | 2023/12/15 13:10:37 |
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Basic information
Public title
Factors Influencing the Retention Rate of Resin Based Pit and Fissure Sealant Among Primary School Children- A Randomized Clinical Trail
Acronym
PFs - Pit and Fissure Sealants
RCT - Randomized Clinical Trail
Scientific Title
Factors Influencing the Retention Rate of Resin Based Pit and Fissure Sealant Among Primary School Children- A Randomized Clinical Trail
Scientific Title:Acronym
Factors Influencing the Retention Rate of Resin Based Pit and Fissure Sealant (PFs) Among Primary School Children- A Randomized Clinical Trail (RCT)
Region
| Asia(except Japan) |
Condition
Condition
Prevention of Dental Caries
Classification by specialty
| Dental medicine | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate retention of Pit and fissure sealants on mandibular permanent first molar among primary school children
Basic objectives2
Others
Basic objectives -Others
1. To assess and compare the retention rate of pit and fissure sealant with or without bonding agent.
2. To assess and compare the retention rate of pit and fissure sealant with or without opening fissures (Altered Morphology).
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Retention of Pit and fissure sealant on occlusal surface of mandibular permanent first molar after 1yr follow-up
Key secondary outcomes
Prevention of Dental caries on Mandibular permanent first of the children
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
active
Interventions/Control_2
active
Interventions/Control_3
active
Interventions/Control_4
placebo
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 6 | years-old | <= |
Age-upper limit
| 9 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Pit and fissure separated by transverse ridge.
2) Recently erupted teeth.
3) Deep, narrow pit and fissure.
Key exclusion criteria
1) Carious pit and fissure
2) Broad/shallow, well coalesced pit and fissure
3) Proximal lesions.
4) Non co-operative children.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Prashanth |
| Middle name | Y |
| Last name | Vishwakarma |
Organization
ACPM Dental College & Hospital
Division name
Public Health Dentistry
Zip code
424001
Address
ACPM Dental College & Hospital, Sakri Road, Dhule, Maharashtra, India
TEL
919766745627
dr_prashanthvk@yahoo.com
Public contact
Name of contact person
| 1st name | Prashanth |
| Middle name | Y |
| Last name | Vishwakarma |
Organization
ACPM Dental College & Hospital
Division name
Public Health Dentistry
Zip code
424001
Address
ACPM Dental College & Hospital, Sakri Road, Dhule, Maharashtra, India
TEL
919766745627
Homepage URL
dr_prashanthvk@yahoo.com
Sponsor or person
Institute
ACPM Dental College Dhule
Institute
Department
Personal name
Dr Prashanth Y Vishwakarma
Funding Source
Organization
ACPM Dental College & Hospital
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
Annasaheb Chudaman Patil Memorial Dental College
Address
Post Box No 145, Sakri Road, Dhule
Tel
+91 256200674
jmfacpmdc@gmail.com
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
ACPM Dental College & Hospital
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
50
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 02 | Day |
Date of closure to data entry
| 2023 | Year | 02 | Month | 10 | Day |
Date trial data considered complete
| 2023 | Year | 02 | Month | 16 | Day |
Date analysis concluded
| 2023 | Year | 02 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 15 | Day |
Last modified on
| 2023 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060606
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