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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. |
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Register:
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EUCTR |
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Last refreshed on:
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30 June 2019 |
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Main ID: |
EUCTR2010-023476-23-GB |
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Date of registration:
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17/02/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Seal or Varnish? A Randomised Trial To Determine The Relative Cost And Effectiveness Of Pit And Fissure Sealants And Fluoride Varnish In Preventing Dental Decay - Seal or Varnish
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Scientific title:
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Seal or Varnish? A Randomised Trial To Determine The Relative Cost And Effectiveness Of Pit And Fissure Sealants And Fluoride Varnish In Preventing Dental Decay - Seal or Varnish |
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Date of first enrolment:
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17/03/2011 |
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Target sample size:
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920 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-023476-23 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: yes
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo:
Other: yes
Other specify the comparator: Delton Light Curing Pit & Fissure Sealant (Dentsply Ltd; CE0086)
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion criteria:
• Year 2 children, (aged 6-7) years, attending the schools participating in the current Cardiff and Vale UHB Designed to Smile Programme
• Children for whom the person with parental responsibility has provided written informed consent
• Children with at least one fully-erupted caries-free first permanent molar (determined at baseline examination)
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
• Children whose medical history precludes inclusion (i.e. those with a history of hospitalisation for asthma, or severe allergies, or allergy to Elastoplast; determined from Medical History Form completed by parents)
• Children with known sensitivity to colophony (kolophonium), or any of the product ingredients (e.g. methylacrylate in PFS; determined from Medical History Form completed by parents)
• Children with ulcerative gingivitis or stomatitis (determined by clinical examination)
• Children with any facial or oral infections e.g. cold sores (determined by clinical examination)
• Children with any abnormality of the lips, face or soft tissues of the mouth that would cause discomfort in the provision of PFS/FV (determined by clinical examination)
• Children who are showing obvious signs of systemic illness (e.g. colds, ‘flu, chicken pox etc) (determined by clinical examination)
• Children currently participating in another clinical trial involving an investigational medicinal product (IMP; determined from Medical History Form completed by parents).
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Dental Caries
MedDRA version: 13.1
Level: LLT
Classification code 10012318
Term: Dental Caries
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Intervention(s)
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Trade Name: Duraphat 50 mg/ml Dental Suspension
Product Name: Duraphat 50 mg/ml dental suspension
Pharmaceutical Form: Dental suspension
INN or Proposed INN: sodium fluoride
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
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Primary Outcome(s)
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Main Objective: The proposed clinical trial will address the following principal research question:
“What is the relative cost and effectiveness of pit and fissure sealants and fluoride varnish in preventing dental decay in the first permanent molar teeth of children”.
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Primary end point(s): The primary outcome measure will be the development of dental caries on first permanent molars at 36 months.
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Secondary Objective: The secondary research objectives are:
• To establish the costs and budget impact of pit and fissure sealants (PFS) and fluoride varnish (FV) delivered in a community/school setting and the relative cost-effectiveness of these technologies
• To examine the impact of PFS and FV on children and their parents/carers in terms of quality of life/treatment acceptability measures.
• To examine the implementation of treatment in a community setting with respect to the experience of children, parents, schools and clinicians.
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Secondary ID(s)
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SPON766-09
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ISRCTN17029222
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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