UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042958
Receipt number 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 20:36:10

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049006


Research Plan
Registered date File name

Research case data specifications
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Research case data
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