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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042958
Receipt No. R000049006
Scientific Title EFFICACY OF PROBIOTIC, CHLORHEXIDINE AND SODIUM FLUORIDE MOUTHRINSES ON MUTANS STREPTOCOCCI IN 8 TO 12 YEAR OLD CHILDREN - A RANDOMIZED CONTROLLED TRIAL
Date of disclosure of the study information 2021/01/09
Last modified on 2021/01/09

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Basic information
Public title EFFICACY OF PROBIOTIC, CHLORHEXIDINE AND SODIUM FLUORIDE MOUTHRINSES ON MUTANS STREPTOCOCCI IN 8 TO 12 YEAR OLD CHILDREN - A RANDOMIZED CONTROLLED TRIAL
Acronym Efficacy of Probiotic, Chlorhexidine and Sodium Fluoride Mouthrinses on Mutans Streptococci in Children
Scientific Title EFFICACY OF PROBIOTIC, CHLORHEXIDINE AND SODIUM FLUORIDE MOUTHRINSES ON MUTANS STREPTOCOCCI IN 8 TO 12 YEAR OLD CHILDREN - A RANDOMIZED CONTROLLED TRIAL
Scientific Title:Acronym Efficacy of Probiotic, Chlorhexidine and Sodium Fluoride Mouthrinses on Mutans Streptococci in Children
Region
Asia(except Japan)

Condition
Condition Children suffering from dental caries between ages of 8 to 12 years.
Classification by specialty
Dental medicine Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 PRIMARY OBJECTIVES:

To compare and assess the efficacy of Probiotic, Chlorhexidine and Sodium Fluoride mouthrinses on the colony counts of Mutans Streptococci(MS) in 8 to 12 year old children.

SECONDARY OBJECTIVES:

1. To assess the patient acceptance to the taste of Probiotic, Chlorhexidine and Sodium Fluoride mouthrinses.

2. To assess the patient compliance to use of Probiotic, Chlorhexidine and Sodium Fluoride mouthrinses.

3. To assess the adverse effects, if any, of Probiotic, Chlorhexidine and Sodium Fluoride mouthrinses.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The independent variables assessed were:

A. Treatment (type of mouthrinse)
1. Probiotic powder
2. 0.2% Chlorhexidine
3. 0.05% Sodium Fluoride

B. Cycle (sequence of drug administration)

The dependent variables assessed were:
1. Number of MS colonies grown on Mitis Salivarius Bacitracin agar.
Key secondary outcomes Confounding (co-variables) variables considered in the analysis were:

1. Age (8 to 10 and 10 to 12 years)
2. Gender


Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 1st phase: Use of 10 ml of allocated mouthrinse by all three groups twice a day for 2 weeks followed by washout period of 4 weeks.
Interventions/Control_2 2nd phase: Use of 10 ml of allocated mouthrinse by all three groups twice a day for 2 weeks followed by washout period of 4 weeks.
Interventions/Control_3 3rd phase: Use of 10 ml of allocated mouthrinse by all three groups twice a day for 2 weeks.
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 1. Children who had completed 8 years on or before 1 st January 2017 and were to complete 12 years on or after 28 th February 2017.
2. ASA category I children.
3. Children who could visit the department for a regular follow up.
4. Children with a Total Caries Score (dmft + DMFT) [d/D-decay, m/M-missing, f/F-filled teeth] [primary + permanent dentition] between four and ten.
Key exclusion criteria 1. Children with a history of recent or ongoing antibiotics.
2. Children undergoing orthodontic treatment or using a prosthesis.
3. Children who could not brush or rinse on their own.
4. Children with any soft tissue intra-oral pathology.
5. Habitual consumption of Probiotics for dental or medical purposes.
6. Children in whom saliva collection was not possible due to physical/medical/mental handicap.
7. Children whose parents or legal guardians did not give informed consent and the child did not give assent.
Target sample size 51

Research contact person
Name of lead principal investigator
1st name KRUTIKA
Middle name YESHWANT
Last name GEDAM
Organization YMT Dental College and Hopital
Division name Department of Pediatric and Preventive Dentistry
Zip code 410210
Address Plot no.18, Sector 4, Kharghar, Navi Mumbai, India.
TEL +91-9820-31-8848
Email dr.krutikagedam@gmail.com

Public contact
Name of contact person
1st name AMAR
Middle name NARAYAN
Last name KATRE
Organization YMT Dental College and Hospital
Division name Department of Pediatric and Preventive Dentistry
Zip code 410210
Address Plot no.18, Sector 4, Kharghar, Navi Mumbai, India.
TEL +91-22-27744429
Homepage URL
Email amar_katre@hotmail.com

Sponsor
Institute Department of Pediatric and Preventive Dentistry,
YMT Dental College and Hospital,
Navi Mumbai, India.
Institute
Department

Funding Source
Organization Not applicable
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization Institutional Review Board, YMT Dental College and Hopital.
Address Plot no.18, Sector 4, Kharghar, Navi Mumbai, India.
Tel +91-22-27744429
Email info@ymtdental.org

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 Department of Pediatric and Preventive Dentistry,
YMT Dental College and Hospital,
Navi Mumbai, India.

Other administrative information
Date of disclosure of the study information
2021 Year 01 Month 09 Day

Related information
URL releasing protocol IAPD CONFERENCE - https://program.eventact.com/viewabstract?Abst=182775&Code=3860959
Publication of results Partially published

Result
URL related to results and publications Results presented at IAPD Global Summit on Early Childhood Caries, November 2018, Thailand.
Number of participants that the trial has enrolled 117
Results The study concluded that Probiotic was as effective as Chlorhexidine and Sodium Fluoride mouth rinses against Mutans Streptococci and may be recommended as a mouth rinse in 8 to 12 year old children.

Results date posted
2021 Year 01 Month 08 Day
Results Delayed
Results Delay Reason Not Applicable
Date of the first journal publication of results
Baseline Characteristics The study population comprised of 51 children who met the inclusion criteria of which 26 (50.98%) were boys and 25 (49.02%) were girls, between the ages 8 to 12 years. Amongst them, 15 (29.41%) were 8 year old, 14 (27.45%) were 9 year old, 8 (15.68%) were 10 year old, 4 (7.84%) were 11 year old and 10 (19.60%) were 12 year old.
Participant flow Of the 117 participants which were screened, 51 participated in the study and 19 completed all the three phases of the study.
The participants were randomly divided in to 3 groups namely Group I, Group II and Group III.
Children in each group received all three mouthrinses, each coded as A, B and C by computer generated randomized allocation.
Adverse events None reported
Outcome measures Reduction in the colony count of Mutans Streptococci (CFU/ml) calculated using mean change and mean percentage change.
An Intent-To-Treat analysis was applied to account for the attrition of the sample. A per protocol analysis was performed on those number of children who completed all the phases.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 11 Month 01 Day
Date of IRB
2015 Year 12 Month 01 Day
Anticipated trial start date
2017 Year 03 Month 04 Day
Last follow-up date
2017 Year 06 Month 11 Day
Date of closure to data entry
2017 Year 07 Month 08 Day
Date trial data considered complete
2017 Year 07 Month 08 Day
Date analysis concluded
2017 Year 09 Month 27 Day

Other
Other related information This trial was conducted as part of the post-graduate program in the Department of Pediatric and Preventive Dentistry, YMT Dental College, Navi Mumbai, INDIA.

The researchers have no conflicts of interest in the trial conducted. The agencies that supplied the materials had no role in conducting this research or on the outcomes

Management information
Registered date
2021 Year 01 Month 09 Day
Last modified on
2021 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049006

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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