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試験進捗状況 試験終了/Completed
UMIN試験ID UMIN000042958
受付番号 R000049006
科学的試験名
一般公開日(本登録希望日) 2021/01/09
最終更新日 2021/01/09

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title
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
Efficacy of Probiotic, Chlorhexidine and Sodium Fluoride Mouthrinses on Mutans Streptococci in Children
科学的試験名/Scientific Title
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
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/Condition
対象疾患名/Condition
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/Objectives
目的1/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.
目的2/Basic objectives2 安全性・有効性/Safety,Efficacy
目的2 -その他詳細/Basic objectives -Others

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

評価/Assessment
主要アウトカム評価項目/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.
副次アウトカム評価項目/Key secondary outcomes
Confounding (co-variables) variables considered in the analysis were:

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


基本事項/Base
試験の種類/Study type 介入/Interventional

試験デザイン/Study design
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

介入/Intervention
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
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
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
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

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
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
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
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/Research contact person
責任研究者/Name of lead principal investigator

ミドルネーム

KRUTIKA
ミドルネーム YESHWANT
GEDAM
所属組織/Organization
YMT Dental College and Hopital
所属部署/Division name
Department of Pediatric and Preventive Dentistry
郵便番号/Zip code 410210
住所/Address
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/Public contact
試験問い合わせ窓口担当者/Name of contact person

ミドルネーム

AMAR
ミドルネーム NARAYAN
KATRE
組織名/Organization
YMT Dental College and Hospital
部署名/Division name
Department of Pediatric and Preventive Dentistry
郵便番号/Zip code 410210
住所/Address
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

実施責任組織/Sponsor
機関名/Institute その他 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)

部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 Not applicable
機関名/Organization
(機関選択不可の場合)

組織名/Division
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


その他の関連組織/Other related organizations
共同実施組織/Co-sponsor
None
その他の研究費提供組織/Name of secondary funder(s)
None

IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization
Institutional Review Board, YMT Dental College and Hopital.
住所/Address
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
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

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions Department of Pediatric and Preventive Dentistry,
YMT Dental College and Hospital,
Navi Mumbai, India.

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2021 01 09

関連情報/Related information
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/Result
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
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 01 08
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason
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
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
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
None reported
評価項目/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.
個別症例データ共有計画/Plan to share IPD

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


試験進捗状況/Progress
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 11 01
倫理委員会による承認日/Date of IRB
2015 12 01
登録・組入れ開始(予定)日/Anticipated trial start date
2017 03 04
フォロー終了(予定)日/Last follow-up date
2017 06 11
入力終了(予定)日/Date of closure to data entry
2017 07 08
データ固定(予定)日/Date trial data considered complete
2017 07 08
解析終了(予定)日/Date analysis concluded
2017 09 27

その他/Other
その他関連情報/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

管理情報/Management information
登録日時/Registered date
2021 01 09
最終更新日/Last modified on
2021 01 09


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000049006
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049006

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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