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

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

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.

Study Overview

• Status: Completed
• Conditions: Cost-effectiveness; Glass Ionomer Cement; Pit and Fissure Caries (Disorder)
• Intervention / Treatment: Drug: resin sealant; Drug: ART sealant

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.

• Study Type: Interventional
• Enrollment (Actual): 329
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Jianxinjie Primary School
    • Zhengzhou, Henan, China, 450000
      • Ruhelu Primary School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 10 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Zhengzhou University
• Investigators: Principal Investigator: Baoying Liu, PhD, Zhengzhou University

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (ACTUAL): June 1, 2018
• Study Completion (ACTUAL): June 1, 2018

Study Registration Dates

• First Submitted: January 23, 2017
• First Submitted That Met QC Criteria: January 24, 2017
• First Posted (ESTIMATE): January 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 8, 2019
• Last Update Submitted That Met QC Criteria: July 4, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 201503121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO