Cost-effectiveness Clinical Trial
Official title:
Economic Evaluation of ART Sealant in Preventing Pit and Fissure Caries in Permanent First Molars in an Asia Population
NCT number | NCT03034837 |
Other study ID # | 201503121 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | January 2016 |
Est. completion date | June 2018 |
Verified date | July 2019 |
Source | Zhengzhou University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Eruption of the first permanent molar is the earliest in our oral cavity, leading to a high
occurrence of dental caries in its pits and fissures. Early prevention of pit and fissure
caries in this tooth is therefore of great importance for the preservation of a healthy
dentition in one's life long time.
It has been shown that sealing the occlusal surface with pit and fissure sealant is a highly
effective method to prevent pit and fissure caries. It has also been shown that the
performance of sealing pits and fissures by glass ionomer materia l (the high viscosity,
classification type 2 GIC material) using finger press method used in the atraumatic
restoration method is as significant as that of using the traditional resin sealant material
and technique.
The purpose of this study is to evaluate the long-term cost-effectiveness performance of the
two sealing materials in the prevention of pits and fissures caries in young permanent molars
of schoolchildren in a dental public health program to be held in primary schools. The
findings will provide valuable information for decision making on the election of proper
material and method for use in dental public program, especially for child population in the
rural or social-economically deprived areas.
Status | Completed |
Enrollment | 329 |
Est. completion date | June 2018 |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 7 Years to 10 Years |
Eligibility |
Inclusion Criteria: - generally healthy grade 1-2 school children - with written parental consent - with at least 1 sound and fully erupted permanent first molar Exclusion Criteria: - Can not cooperate with the treatment - Can not obtain the child's parental consent |
Country | Name | City | State |
---|---|---|---|
China | Jianxinjie Primary School | Zhengzhou | Henan |
China | Ruhelu Primary School | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
Zhengzhou University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | cost-effectiveness of sealing | the incrental cost-effectiveness ratio of different sealing material used in this study in preventing pit and fissure caries in the permanent molars. | 24-month |
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