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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
Sponsor:
Information provided by (Responsible Party):
Liu Baoying, Zhengzhou University

Brief Summary:

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

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 329 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
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.
Other Names:
  • GIC sealant
  • 3M ESPE KetacTM Molar Easymix" glass ionomer cement




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   7 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
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China, Henan
Jianxinjie Primary School
Zhengzhou, Henan, China, 450000
Ruhelu Primary School
Zhengzhou, Henan, China, 450000
Sponsors and Collaborators
Zhengzhou University
Investigators
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Principal Investigator: Baoying Liu, PhD Zhengzhou University

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Responsible Party: Liu Baoying, Dr., Zhengzhou University
ClinicalTrials.gov Identifier: NCT03034837     History of Changes
Other Study ID Numbers: 201503121
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors