Effectiveness and Economic Evaluation of Glass Ionomer Material Using as Dental Sealant
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|ClinicalTrials.gov Identifier: NCT03034837|
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : July 8, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Glass Ionomer Cement Cost-effectiveness Pit and Fissure Caries (Disorder)||Drug: resin sealant Drug: ART sealant||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||329 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Health Services Research|
|Official Title:||Economic Evaluation of ART Sealant in Preventing Pit and Fissure Caries in Permanent First Molars in an Asia Population|
|Study Start Date :||January 2016|
|Actual Primary Completion Date :||June 2018|
|Actual Study Completion Date :||June 2018|
Active Comparator: Resin sealant
Sealing pit and fissures of the included permanent first molars using "SDI conseal f" resin sealant material once at the baseline of the study.
Drug: resin sealant
Sealing the occlusal surface of the included molars using the market product of SDI conseal f once.
Other Name: SDI conseal f
Experimental: ART sealant
Sealing pit and fissures of the included permanent first molars using "3M ESPE KetacTM Molar Easymix" glass ionomer cement material once at the baseline of the study.
Drug: ART sealant
Sealing the occlusal surface of the included molars using the market product of 3M ESPE KetacTM Molar Easymix" glass ionomer cement once.
- cost-effectiveness of sealing [ Time Frame: 24-month ]the incrental cost-effectiveness ratio of different sealing material used in this study in preventing pit and fissure caries in the permanent molars.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034837
|Jianxinjie Primary School|
|Zhengzhou, Henan, China, 450000|
|Ruhelu Primary School|
|Zhengzhou, Henan, China, 450000|
|Principal Investigator:||Baoying Liu, PhD||Zhengzhou University|