UMIN-CTR 臨床試験登録情報の閲覧

一般向け試験名/Public title

日本語

英語
EFFICACY OF PROBIOTIC, CHLORHEXIDINE AND SODIUM FLUORIDE MOUTHRINSES ON MUTANS STREPTOCOCCI IN 8 TO 12 YEAR OLD CHILDREN - A RANDOMIZED CONTROLLED TRIAL

一般向け試験名略称/Acronym

日本語

英語
Efficacy of Probiotic, Chlorhexidine and Sodium Fluoride Mouthrinses on Mutans Streptococci in Children

科学的試験名/Scientific Title

日本語

英語
EFFICACY OF PROBIOTIC, CHLORHEXIDINE AND SODIUM FLUORIDE MOUTHRINSES ON MUTANS STREPTOCOCCI IN 8 TO 12 YEAR OLD CHILDREN - A RANDOMIZED CONTROLLED TRIAL

科学的試験名略称/Scientific Title:Acronym

日本語

英語
Efficacy of Probiotic, Chlorhexidine and Sodium Fluoride Mouthrinses on Mutans Streptococci in Children

試験実施地域/Region

アジア（日本以外）/Asia(except Japan)

対象疾患名/Condition

日本語

英語
Children suffering from dental caries between ages of 8 to 12 years.

疾患区分1/Classification by specialty

歯学/Dental medicine	小児/Child

疾患区分2/Classification by malignancy

悪性腫瘍以外/Others

ゲノム情報の取扱い/Genomic information

いいえ/NO

目的1/Narrative objectives1

日本語

英語
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.

目的2/Basic objectives2

安全性・有効性/Safety,Efficacy

目的2 -その他詳細/Basic objectives -Others

日本語

英語

試験の性質1/Trial characteristics_1

検証的/Confirmatory

試験の性質2/Trial characteristics_2

説明的/Explanatory

試験のフェーズ/Developmental phase

該当せず/Not applicable

主要アウトカム評価項目/Primary outcomes

日本語

英語
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.

副次アウトカム評価項目/Key secondary outcomes

日本語

英語
Confounding (co-variables) variables considered in the analysis were:

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

試験の種類/Study type

介入/Interventional

基本デザイン/Basic design

クロスオーバー試験/Cross-over

ランダム化/Randomization

ランダム化/Randomized

ランダム化の単位/Randomization unit

個別/Individual

ブラインド化/Blinding

二重盲検/Double blind -all involved are blinded

コントロール/Control

実薬・標準治療対照/Active

層別化/Stratification

はい/YES

動的割付/Dynamic allocation

いいえ/NO

試験実施施設の考慮/Institution consideration

ブロック化/Blocking

割付コードを知る方法/Concealment

封筒法/Numbered container method

群数/No. of arms

3

介入の目的/Purpose of intervention

予防・検診・検査/Prevention

介入の種類/Type of intervention

医薬品/Medicine

介入1/Interventions/Control_1

日本語

英語
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.

介入2/Interventions/Control_2

日本語

英語
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.

介入3/Interventions/Control_3

日本語

英語
3rd phase: Use of 10 ml of allocated mouthrinse by all three groups twice a day for 2 weeks.

介入4/Interventions/Control_4

日本語

英語

介入5/Interventions/Control_5

日本語

英語

介入6/Interventions/Control_6

日本語

英語

介入7/Interventions/Control_7

日本語

英語

介入8/Interventions/Control_8

日本語

英語

介入9/Interventions/Control_9

日本語

英語

介入10/Interventions/Control_10

日本語

英語

年齢（下限）/Age-lower limit

8

歳/years-old

以上/<=

年齢（上限）/Age-upper limit

12

歳/years-old

以下/>=

性別/Gender

男女両方/Male and Female

選択基準/Key inclusion criteria

日本語

英語
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.

除外基準/Key exclusion criteria

日本語

英語
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.

目標参加者数/Target sample size

51

責任研究者/Name of lead principal investigator

日本語

名
ミドルネーム
姓

英語

名	KRUTIKA
ミドルネーム	YESHWANT
姓	GEDAM

所属組織/Organization

日本語

英語
YMT Dental College and Hopital

所属部署/Division name

日本語

英語
Department of Pediatric and Preventive Dentistry

郵便番号/Zip code

410210

住所/Address

日本語

英語
Plot no.18, Sector 4, Kharghar, Navi Mumbai, India.

電話/TEL

+91-9820-31-8848

Email/Email

dr.krutikagedam@gmail.com

試験問い合わせ窓口担当者/Name of contact person

日本語

名
ミドルネーム
姓

英語

名	AMAR
ミドルネーム	NARAYAN
姓	KATRE

組織名/Organization

日本語

英語
YMT Dental College and Hospital

部署名/Division name

日本語

英語
Department of Pediatric and Preventive Dentistry

郵便番号/Zip code

410210

住所/Address

日本語

英語
Plot no.18, Sector 4, Kharghar, Navi Mumbai, India.

電話/TEL

+91-22-27744429

試験のホームページURL/Homepage URL

Email/Email

amar_katre@hotmail.com

機関名/Institute

日本語
その他

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

機関名/Institute
（機関選択不可の場合）

日本語

部署名/Department

日本語

個人名/Personal name

日本語

英語

機関名/Organization

日本語
その他

英語
Not applicable

機関名/Organization
（機関選択不可の場合）

日本語

組織名/Division

日本語

組織の区分/Category of Funding Organization

自己調達/Self funding

研究費拠出国/Nationality of Funding Organization

日本語

英語

共同実施組織/Co-sponsor

日本語

英語
None

その他の研究費提供組織/Name of secondary funder(s)

日本語

英語
None

組織名/Organization

日本語

英語
Institutional Review Board, YMT Dental College and Hopital.

住所/Address

日本語

英語
Plot no.18, Sector 4, Kharghar, Navi Mumbai, India.

電話/Tel

+91-22-27744429

Email/Email

info@ymtdental.org

他機関から発行された試験ID/Secondary IDs

いいえ/NO

試験ID1/Study ID_1

ID発行機関1/Org. issuing International ID_1

日本語

英語

試験ID2/Study ID_2

ID発行機関2/Org. issuing International ID_2

日本語

英語

治験届/IND to MHLW

試験実施施設名称/Institutions

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

一般公開日（本登録希望日）/Date of disclosure of the study information

2021

年

01

月

09

日

プロトコル掲載URL/URL releasing protocol

IAPD CONFERENCE - https://program.eventact.com/viewabstract?Abst=182775&Code=3860959

試験結果の公開状況/Publication of results

中間解析等の途中公開/Partially published

結果掲載URL/URL related to results and publications

Results presented at IAPD Global Summit on Early Childhood Caries, November 2018, Thailand.

組み入れ参加者数/Number of participants that the trial has enrolled

117

主な結果/Results

日本語

英語
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.

主な結果入力日/Results date posted

2021

年

01

月

08

日

結果掲載遅延/Results Delayed

結果遅延理由/Results Delay Reason

日本語

英語
Not Applicable

最初の試験結果の出版日/Date of the first journal publication of results

参加者背景/Baseline Characteristics

日本語

英語
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.

参加者の流れ/Participant flow

日本語

英語
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.

有害事象/Adverse events

日本語

英語
None reported

評価項目/Outcome measures

日本語

英語
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.

個別症例データ共有計画/Plan to share IPD

日本語

英語

個別症例データ共有計画の詳細/IPD sharing Plan description

日本語

英語

試験進捗状況/Recruitment status

試験終了/Completed

プロトコル確定日/Date of protocol fixation

2015

年

11

月

01

日

倫理委員会による承認日/Date of IRB

2015

年

12

月

01

日

登録・組入れ開始（予定）日/Anticipated trial start date

2017

年

03

月

04

日

フォロー終了(予定)日/Last follow-up date

2017

年

06

月

11

日

入力終了(予定)日/Date of closure to data entry

2017

年

07

月

08

日

データ固定（予定）日/Date trial data considered complete

2017

年

07

月

08

日

解析終了(予定)日/Date analysis concluded

2017

年

09

月

27

日

その他関連情報/Other related information

日本語

英語
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

登録日時/Registered date

2021

年

01

月

09

日

最終更新日/Last modified on

2021

年

01

月

09

日

閲覧ページへのリンク/Link to view the page

日本語
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000049006

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