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
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
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
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
