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

NCT03034837 | Completed Phase 4

• 1 other identifier: 201503121
• Study Type: interventional
• Target: 329
• Locations: 1 country
• Sites: 2

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.

Conditions

Glass Ionomer Cement; Cost-effectiveness; Pit and Fissure Caries (Disorder)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Resin sealant

ACTIVE COMPARATOR

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

ART sealant

EXPERIMENTAL

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

Interventions

resin sealant DRUG

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

Also known as: SDI conseal f

Resin sealant

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.

Also known as: GIC sealant, 3M ESPE KetacTM Molar Easymix" glass ionomer cement

ART sealant

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• generally healthy grade 1-2 school children
• with written parental consent
• with at least 1 sound and fully erupted permanent first molar

You may not qualify if:

• Can not cooperate with the treatment
• Can not obtain the child's parental consent

Sponsors & Collaborators

• Zhengzhou University: lead

Study Sites (2)

Jianxinjie Primary School

Zhengzhou, Henan, 450000, China

Location

Ruhelu Primary School

Zhengzhou, Henan, 450000, China

Location

MeSH Terms

Conditions

Van der Woude syndrome

Study Officials

• Baoying Liu, PhD

  Zhengzhou University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: January 23, 2017
• First Posted: January 27, 2017
• Study Start: January 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: July 8, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)