UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000037668
Receipt No. 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 (Ver. 1)

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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
Email 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
Email tanushreedalvi92@gmail.com

Sponsor
Institute Department of Public Health Dentistry, Bapuji Dental College and hospital, Davangere, Karnataka, India
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042957