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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ChiCTR
Last refreshed on: 18 April 2017
Main ID:  ChiCTR-TRC-13003764
Date of registration: 2013-11-09
Prospective Registration: No
Primary sponsor: West China School of Stomatology, Sichuan University
Public title: Assessment of fluoride varnish and fluoride film for white spot lesion around orthodontic brackets after orthodontic treatment
Scientific title: Assessment of fluoride varnish and fluoride film for white spot lesion around orthodontic brackets after orthodontic treatment
Date of first enrolment: 2011-12-24
Target sample size: Control group:80;Fluoride varnish group:80;Fluoride film group:80;
Recruitment status: Completed
URL:  http://www.chictr.org.cn/showproj.aspx?proj=5796
Study type:  Interventional study
Study design:  Randomized parallel controlled trial  
Phase:  I (Phase I study)
Countries of recruitment
China
Contacts
Name: Tao He   
Address:  NO.14, 3rd Section of Ren Min Nan Rd. Chengdu, Sichuan 610041, China
Telephone: +86 13880456741
Email: 229880130@qq.com
Affiliation:  West China School of Stomatology, Sichuan University
Name: Deyu Hu   
Address:  NO.14, 3rd Section of Ren Min Nan Rd. Chengdu, Sichuan 610041, China
Telephone: +86 13908034990
Email: hudeyu@vip.sina.com
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: Aged between 12 and 25Good general health, no systemic deseaseAt least 4 upper anterior teeth of which at least 1 tooth had white spot lesion on its buccal surfaceSubjects can take a 6-month clinic study and understand test requirementsSubject do not take part in other similar clinical study
Exclusion criteria: Were Subject is suffering from oral ulcer, ulcerous gingivitis or acute bronchial asthma;
Subjects will be or are being treated with fluoride;
Subject is from the high fluorine area;
Woman who is known to be pregnant or in suckling period over the duration of the study.


Age minimum: 12
Age maximum: 25
Gender: Both
Health Condition(s) or Problem(s) studied
early cary, white spot lesion
Intervention(s)
Control group:Placebo treatment;Fluoride varnish group:Fluoride varnish treatment per one month;Fluoride film group:Fluoride varnish treatment per one month;
Primary Outcome(s)
?F;white spot area;?Q;
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Prevention Department, West China School of Stomatology, Sichuan University
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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