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Completed

NCT Number: NCT03034837

Effectiveness and Economic Evaluation of Glass Ionomer Material Using as Dental Sealant

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.

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Key information

Age range

7 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Jianxinjie Primary School, Zhengzhou, Henan, China

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About this study

Primary school children will be recruited and cluster randomized into three groups. Baseline dental check-up will be conducted to all the recruited children and dental status will be recorded. Placement of resin sealant or sealant using the glass ionomer material to the eligible permanent first molars or providing of oral health education will be interventions to the three groups respecively according to the group allocation. All the interventions will be provided only once in this study, and the children will be followed for at least 24 months at an six month interval to motor the dental caries of the included permanent first molars. Cost-effectiveness of placement of resin sealant and glass ionomer sealant will be evaluated and reported.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

resin sealant

Drug

Sealing the occlusal surface of the included molars using the market product of SDI conseal f once.

Other names: SDI conseal f

ART sealant

Drug

Sealing the occlusal surface of the included molars using the market product of 3M ESPE KetacTM Molar Easymix" glass ionomer cement once.

Other names: GIC sealant, 3M ESPE KetacTM Molar Easymix" glass ionomer cement

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Zhengzhou University

Other

Registry information

Official study title

Economic Evaluation of ART Sealant in Preventing Pit and Fissure Caries in Permanent First Molars in an Asia Population

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 27, 2017
Registry last updated
Jul 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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