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
COMPARATIVE EVALUATION OF RETENTION RATES OF AMORPHOUS CALCIUM PHOSPHATE SEALANT AND RESIN BASED SEALANT ON PERMANENT 1st MOLARS IN 6-9 YEAR OLD CHILDREN: A RANDOMIZED CONTROLLED TRIAL

一般向け試験名略称/Acronym

日本語

英語
COMPARATIVE EVALUATION OF RETENTION RATES OF AMORPHOUS CALCIUM PHOSPHATE SEALANT AND RESIN BASED SEALANT ON PERMANENT 1st MOLARS IN 6-9 YEAR OLD CHILDREN: A RANDOMIZED CONTROLLED TRIAL

科学的試験名/Scientific Title

日本語

英語
COMPARATIVE EVALUATION OF RETENTION RATES OF AMORPHOUS CALCIUM PHOSPHATE SEALANT AND RESIN BASED SEALANT ON PERMANENT 1st MOLARS IN 6-9 YEAR OLD CHILDREN: A RANDOMIZED CONTROLLED TRIAL

科学的試験名略称/Scientific Title:Acronym

日本語

英語
COMPARATIVE EVALUATION OF RETENTION RATES OF AMORPHOUS CALCIUM PHOSPHATE SEALANT AND RESIN BASED SEALANT ON PERMANENT 1st MOLARS IN 6-9 YEAR OLD CHILDREN: A RANDOMIZED CONTROLLED TRIAL

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
Prevention of Dental Caries

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
1.To assess the retention rates of Amorphous Calcium Phosphate based sealant (Aegis) on permanent first molars at 3, 6 and 12 months post application in 6-9 year old children in Davangere city.
2.To assess the retention rates of resin based sealant (Clinpro) on permanent first molars at 3, 6 and 12 months post application in 6-9 year old children in Davangere city.
3.To compare the retention rates of Amorphous Calcium Phosphate based sealant (Aegis) and Resin based sealant (Clinpro) on permanent first molars at 3, 6 and 12 months post application in 6-9 year old children in Davangere city.

目的2/Basic objectives2

その他/Others

目的2 -その他詳細/Basic objectives -Others

日本語

英語
To compare the retention rates of Amorphous Calcium Phosphate based sealant (Aegis) and Resin based sealant (Clinpro) on permanent first molars at 3, 6 and 12 months post application in 6-9 year old children in Davangere city.

試験の性質1/Trial characteristics_1

その他/Others

試験の性質2/Trial characteristics_2

その他/Others

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
Retention of pit and fissure sealants at the end of 3,6 and 12 months into 3 categories:
complete retention, partial retention and missing sealant based on Simonsen's Evaluation criteria for pit and fissure sealants

副次アウトカム評価項目/Key secondary outcomes

日本語

英語
change in oral hygiene status and decayed, missing and filled tooth surfaces evaluated by OHI-S and DMFS index

試験の種類/Study type

介入/Interventional

基本デザイン/Basic design

並行群間比較/Parallel

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

試験参加者がブラインド化されている単盲検/Single blind -participants are blinded

コントロール/Control

実薬・標準治療対照/Active

層別化/Stratification

いいえ/NO

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

いいえ/NO

割付コードを知る方法/Concealment

封筒法/Numbered container method

群数/No. of arms

2

介入の目的/Purpose of intervention

予防・検診・検査/Prevention

介入の種類/Type of intervention

その他/Other

介入1/Interventions/Control_1

日本語

英語
Application of Aegis pit and fissure sealant on 1st permanent molars of 6-9 year old children

介入2/Interventions/Control_2

日本語

英語
Application of Clinpro pit and fissure sealant on 1st permanent molars of 6-9 year old children

介入3/Interventions/Control_3

日本語

英語

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

6

歳/years-old

以上/<=

年齢（上限）/Age-upper limit

9

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.School children aged between 6-9 years with all four completely erupted, caries free permanent 1st molars with deep pits and fissures which are non-restored and unsealed, occlusal surface fully visible and free of mucosal tissue.
2.Subjects who were likely to participate in the study at all the time intervals of the study period.
3.Subjects whose guardians consented to their participation.

除外基準/Key exclusion criteria

日本語

英語
1.Children with carious, restored, grossly decayed, mal-aligned, fractured, attrited teeth or with any caries preventive measure carried out in any of the permanent first molars.
2.Children with developmental anomalies of first permanent molars.
3.Long term regimen of medication that could affect the salivary flow such as Antihistamines, Antipsychotics, Antidepressants, Decongestants, Bronchodilators and Hypnotics.
4.Uncooperative children.
5.History of para-functional habits like bruxism, mouth breathing, tongue thrusting, thumb/finger sucking etc.

目標参加者数/Target sample size

60

責任研究者/Name of lead principal investigator

日本語

名
ミドルネーム
姓

英語

名	Dr. Tanushri
ミドルネーム	Mahendra
姓	Dalvi

所属組織/Organization

日本語

英語
Bharati Vidyapeeth Deemed University Dental college and hospital, Sangli.

所属部署/Division name

日本語

英語
Sangli, Maharashtra, India

郵便番号/Zip code

416416

住所/Address

日本語

英語
Bharati Vidyapeeth Deemed University Dental college and hospital, Wanlesswadi, Sangli, Maharashtra, India

電話/TEL

0251-2329184

Email/Email

tanushreedalvi92@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	Dr. Tanushri
ミドルネーム	Mahendra
姓	Dalvi

組織名/Organization

日本語

英語
Bharati Vidyapeeth Deemed University Dental college and hospital, Sangli.

部署名/Division name

日本語

英語
Sangli, Maharashtra, India

郵便番号/Zip code

416416

住所/Address

日本語

英語
Bharati Vidyapeeth Deemed University Dental college and hospital, Wanlesswadi, Sangli, Maharashtra,

電話/TEL

0251-2329184

試験のホームページURL/Homepage URL

Email/Email

tanushreedalvi92@gmail.com

機関名/Institute

日本語
その他

英語
Department of Public Health Dentistry, Bapuji Dental College and hospital, Davangere, Karnataka, 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
Department of Public Health Dentistry, Bapuji Dental College and hospital, Davangere, Karnataka, India

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

その他/Other

研究費拠出国/Nationality of Funding Organization

日本語

英語
India

共同実施組織/Co-sponsor

日本語

英語

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

日本語

英語

組織名/Organization

日本語

英語
Department of Public Health Dentistry, Bapuji Dental College and hospital, Davangere, Karnataka, India

住所/Address

日本語

英語
Bapuji Dental College and hospital, MCC B block, Davangere, Karnataka, India

電話/Tel

9108192220573

Email/Email

bapujidental@gmail.com

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

Bapuji Dental College and Hospital, Davangere, Karnataka, India.

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

2019

年

08

月

12

日

プロトコル掲載URL/URL releasing protocol

rguhs.ac.in

試験結果の公開状況/Publication of results

未公表/Unpublished

結果掲載URL/URL related to results and publications

rguhs.ac.in

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

30

主な結果/Results

日本語

英語
The complete retention rates of Aegis sealant at 3, 6 and 12 months were 96.7%, 63.3% and 53.3% respectively. The complete retention rates of Clinpro sealants at 3, 6 and 12 months were 96.7%, 76.7% and 46.7% respectively. The mean survival time for Aegis and Clinpro sealants were 9.7 months and 10.5 months respectively. Complete sealant retention rates was significantly higher (72.7%) in moderate caries risk group as compared to high caries risk group (23.5%).

主な結果入力日/Results date posted

2019

年

08

月

12

日

結果掲載遅延/Results Delayed

結果遅延理由/Results Delay Reason

日本語

英語

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
6-9 year old children having deep retentive pits and fissures on 1st permanent molars.

参加者の流れ/Participant flow

日本語

英語
The complete retention rates of Aegis sealant at 3, 6 and 12 months were 96.7%, 63.3% and 53.3% respectively. The complete retention rates of Clinpro sealants at 3, 6 and 12 months were 96.7%, 76.7% and 46.7% respectively. The mean survival time for Aegis and Clinpro sealants were 9.7 months and 10.5 months respectively. Complete sealant retention rates was significantly higher (72.7%) in moderate caries risk group as compared to high caries risk group (23.5%).

有害事象/Adverse events

日本語

英語
None

評価項目/Outcome measures

日本語

英語
Retention of Pit and fissure sealants categorised as: complete retention, partial retention and total loss.

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

09

月

08

日

倫理委員会による承認日/Date of IRB

2015

年

11

月

05

日

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

2016

年

06

月

20

日

フォロー終了(予定)日/Last follow-up date

2017

年

07

月

30

日

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

2017

年

08

月

05

日

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

2017

年

08

月

10

日

解析終了(予定)日/Date analysis concluded

2017

年

09

月

08

日

その他関連情報/Other related information

日本語

英語

登録日時/Registered date

2019

年

08

月

12

日

最終更新日/Last modified on

2019

年

08

月

12

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=R000042957

英語
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042957