UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037668 |
|---|---|
| Receipt number | R000042957 |
| Scientific Title | COMPARATIVE EVALUATION OF RETENTION RATES OF AMORPHOUS CALCIUM PHOSPHATE SEALANT AND RESIN BASED SEALANT ON PERMANENT 1st MOLARS IN 6-9 YEAR OLD CHILDREN: A RANDOMIZED CONTROLLED TRIAL |
| Date of disclosure of the study information | 2019/08/12 |
| Last modified on | 2019/08/12 18:31:56 |
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Basic information
Public title
COMPARATIVE EVALUATION OF RETENTION RATES OF AMORPHOUS CALCIUM PHOSPHATE SEALANT AND RESIN BASED SEALANT ON PERMANENT 1st MOLARS IN 6-9 YEAR OLD CHILDREN: A RANDOMIZED CONTROLLED TRIAL
Acronym
COMPARATIVE EVALUATION OF RETENTION RATES OF AMORPHOUS CALCIUM PHOSPHATE SEALANT AND RESIN BASED SEALANT ON PERMANENT 1st MOLARS IN 6-9 YEAR OLD CHILDREN: A RANDOMIZED CONTROLLED TRIAL
Scientific Title
COMPARATIVE EVALUATION OF RETENTION RATES OF AMORPHOUS CALCIUM PHOSPHATE SEALANT AND RESIN BASED SEALANT ON PERMANENT 1st MOLARS IN 6-9 YEAR OLD CHILDREN: A RANDOMIZED CONTROLLED TRIAL
Scientific Title:Acronym
COMPARATIVE EVALUATION OF RETENTION RATES OF AMORPHOUS CALCIUM PHOSPHATE SEALANT AND RESIN BASED SEALANT ON PERMANENT 1st MOLARS IN 6-9 YEAR OLD CHILDREN: A RANDOMIZED CONTROLLED TRIAL
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
1.To assess the retention rates of Amorphous Calcium Phosphate based sealant (Aegis) on permanent first molars at 3, 6 and 12 months post application in 6-9 year old children in Davangere city.
2.To assess the retention rates of resin based sealant (Clinpro) on permanent first molars at 3, 6 and 12 months post application in 6-9 year old children in Davangere city.
3.To compare the retention rates of Amorphous Calcium Phosphate based sealant (Aegis) and Resin based sealant (Clinpro) on permanent first molars at 3, 6 and 12 months post application in 6-9 year old children in Davangere city.
Basic objectives2
Others
Basic objectives -Others
To compare the retention rates of Amorphous Calcium Phosphate based sealant (Aegis) and Resin based sealant (Clinpro) on permanent first molars at 3, 6 and 12 months post application in 6-9 year old children in Davangere city.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Retention of pit and fissure sealants at the end of 3,6 and 12 months into 3 categories:
complete retention, partial retention and missing sealant based on Simonsen's Evaluation criteria for pit and fissure sealants
Key secondary outcomes
change in oral hygiene status and decayed, missing and filled tooth surfaces evaluated by OHI-S and DMFS index
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Application of Aegis pit and fissure sealant on 1st permanent molars of 6-9 year old children
Interventions/Control_2
Application of Clinpro pit and fissure sealant on 1st permanent molars of 6-9 year old children
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
| 6 | years-old | <= |
Age-upper limit
| 9 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.School children aged between 6-9 years with all four completely erupted, caries free permanent 1st molars with deep pits and fissures which are non-restored and unsealed, occlusal surface fully visible and free of mucosal tissue.
2.Subjects who were likely to participate in the study at all the time intervals of the study period.
3.Subjects whose guardians consented to their participation.
Key exclusion criteria
1.Children with carious, restored, grossly decayed, mal-aligned, fractured, attrited teeth or with any caries preventive measure carried out in any of the permanent first molars.
2.Children with developmental anomalies of first permanent molars.
3.Long term regimen of medication that could affect the salivary flow such as Antihistamines, Antipsychotics, Antidepressants, Decongestants, Bronchodilators and Hypnotics.
4.Uncooperative children.
5.History of para-functional habits like bruxism, mouth breathing, tongue thrusting, thumb/finger sucking etc.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Dr. Tanushri |
| Middle name | Mahendra |
| Last name | Dalvi |
Organization
Bharati Vidyapeeth Deemed University Dental college and hospital, Sangli.
Division name
Sangli, Maharashtra, India
Zip code
416416
Address
Bharati Vidyapeeth Deemed University Dental college and hospital, Wanlesswadi, Sangli, Maharashtra, India
TEL
0251-2329184
tanushreedalvi92@gmail.com
Public contact
Name of contact person
| 1st name | Dr. Tanushri |
| Middle name | Mahendra |
| Last name | Dalvi |
Organization
Bharati Vidyapeeth Deemed University Dental college and hospital, Sangli.
Division name
Sangli, Maharashtra, India
Zip code
416416
Address
Bharati Vidyapeeth Deemed University Dental college and hospital, Wanlesswadi, Sangli, Maharashtra,
TEL
0251-2329184
Homepage URL
tanushreedalvi92@gmail.com
Sponsor or person
Institute
Department of Public Health Dentistry, Bapuji Dental College and hospital, Davangere, Karnataka, India
Institute
Department
Personal name
Funding Source
Organization
Department of Public Health Dentistry, Bapuji Dental College and hospital, Davangere, Karnataka, India
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
India
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Public Health Dentistry, Bapuji Dental College and hospital, Davangere, Karnataka, India
Address
Bapuji Dental College and hospital, MCC B block, Davangere, Karnataka, India
Tel
9108192220573
bapujidental@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
Bapuji Dental College and Hospital, Davangere, Karnataka, India.
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 12 | Day |
Related information
URL releasing protocol
rguhs.ac.in
Publication of results
Unpublished
Result
URL related to results and publications
rguhs.ac.in
Number of participants that the trial has enrolled
30
Results
The complete retention rates of Aegis sealant at 3, 6 and 12 months were 96.7%, 63.3% and 53.3% respectively. The complete retention rates of Clinpro sealants at 3, 6 and 12 months were 96.7%, 76.7% and 46.7% respectively. The mean survival time for Aegis and Clinpro sealants were 9.7 months and 10.5 months respectively. Complete sealant retention rates was significantly higher (72.7%) in moderate caries risk group as compared to high caries risk group (23.5%).
Results date posted
| 2019 | Year | 08 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
6-9 year old children having deep retentive pits and fissures on 1st permanent molars.
Participant flow
The complete retention rates of Aegis sealant at 3, 6 and 12 months were 96.7%, 63.3% and 53.3% respectively. The complete retention rates of Clinpro sealants at 3, 6 and 12 months were 96.7%, 76.7% and 46.7% respectively. The mean survival time for Aegis and Clinpro sealants were 9.7 months and 10.5 months respectively. Complete sealant retention rates was significantly higher (72.7%) in moderate caries risk group as compared to high caries risk group (23.5%).
Adverse events
None
Outcome measures
Retention of Pit and fissure sealants categorised as: complete retention, partial retention and total loss.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 08 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 08 | Month | 05 | Day |
Date trial data considered complete
| 2017 | Year | 08 | Month | 10 | Day |
Date analysis concluded
| 2017 | Year | 09 | Month | 08 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 12 | Day |
Last modified on
| 2019 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042957
