UMIN-CTR Clinical Trial

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
Registered date	File name

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