Ignite Creation Date:
2024-05-06 @ 12:53 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03870958
Status:
UNKNOWN
Last Update Posted:
2020-09-16
First Post:
2018-12-03
Brief Title:
Glass Ionomer Cement Sealant in the Prevention of Post-eruptive Fractures in Molars Affected by MIH
Sponsor:
Isabel Cristina Olegário da Costa
Organization:
University of Sao Paulo
Study Overview
Official Title:
Cost-effectiveness of the Application of Glass Ionomer Cement Sealant GC Fuji TRIAGE in the Prevention of Post-eruptive Fractures in Molars Affected by Molar-Incisor Hipomineralisation Controlled and Randomized Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2020-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIHMex
Brief Summary:
This trial will compare the application of Glass Ionomer Cement GIC sealant with no-intervention for the most clinically- and cost-effective strategy for managing MIH molars without post-eruptive breakdown in a school setting using low-technology and child-friendly dental techniques MethodsDesign This two-arm parallel group patient-randomized controlled superiority trial will have treatment provided in schools Schoolchildren age 6-9 presenting at least one MIH molar n molars 195 will have random allocation to treatment with or without the application of a GIC sealant GC Fuji TRIAGE GC Europe Leuven Belgium Baseline measures and outcome data will be assessed through participant report and clinical examination The primary outcome is the presence of post-eruptive fracture and development of caries lesions Secondary outcomes are 1 self-reported dental hypersensitivity 2 oral health-related-quality of life reported by children 3 plaque index 4 gingival health 5 caries status according to ICCMS scores in primary and permanent teeth 6 the incremental cost-effectiveness A trained and calibrated examiner will evaluate the treated teeth every six months post treatment for a period of 36 months Kaplan-Meier and Cox regression tests will be used to investigate the primary outcome The Logistic Regression and Poisson Regression Analysis will be used to analyze the secondary outcomes α5
Detailed Description:
Background Molar-Incisor Hypomineralisation MIH is defined as a qualitative defect that occurs during the mineralization phase of enamel of at least one first permanent molar The opacities vary in size and color and are demarcated by healthy enamel MIH molars present lower mechanical properties when compared to non-affected molars due to the enamels decreased mineralization Allied to that patients often report dental hypersensitivity which impairs the mechanical removal of dental plaque therefore those molars are more prone to post-eruptive fractures and present higher risk of developing dental caries This trial will compare the application of Glass Ionomer Cement GIC sealant with no-intervention for the most clinically- and cost-effective strategy for managing MIH molars without post-eruptive breakdown in a school setting using low-technology and child-friendly dental techniques MethodsDesign This two-arm parallel group patient-randomized controlled superiority trial will have treatment provided in schools Schoolchildren age 6-9 presenting at least one MIH molar n molars 195 will have random allocation to treatment with or without the application of a GIC sealant GC Fuji TRIAGE GC Europe Leuven Belgium Baseline measures and outcome data will be assessed through participant report and clinical examination The primary outcome is the presence of post-eruptive fracture and development of caries lesions Secondary outcomes are 1 self-reported dental hypersensitivity 2 oral health-related-quality of life reported by children 3 plaque index 4 gingival health 5 caries status according to ICCMS scores in primary and permanent teeth 6 the incremental cost-effectiveness A trained and calibrated examiner will evaluate the treated teeth every six months post treatment for a period of 36 months Kaplan-Meier and Cox regression tests will be used to investigate the primary outcome The Logistic Regression and Poisson Regression Analysis will be used to analyze the secondary outcomes α5
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None