Restoration Quality in Molars Affected by Molar Incisor Hypo Mineralization

Not Applicable

• Conditions: Molar Incisor Hypomineralization
• Interventions: Procedure: preformed stainless steel crowns cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)

• Registration Number: NCT04475419
• Lead Sponsor: Cairo University

Brief Summary

Restoration quality of molars affected by MIH using two different types of restorations direct composite and preformed crowns

Detailed Description

MIH or molar incisor hypomineralization is one of the difficult clinical situations to be managed by dentists the aim of this study is to specify which is the better treatment among composite restorations and preformed crowns in terms of gingival health patient satisfaction pain hypersensetivity acceptability by the patienat hypersensetivity and the need for future retreatment

Study Timeline

• Study First Submitted: 2019-07-31
• Status Verified: 2020-07
• Study First Submitted QC: 2020-07-14
• Last Update Submitted: 2020-07-14
• Study First Posted: 2020-07-17
• Last Update Posted: 2020-07-17
• Study Start: 2020-09-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

.Children with molar incisor hypo mineralization in one fully erupted molar or more.

• Age ranging from 7-12 years.
• Cooperative children
• Good general health

Exclusion Criteria

• Patients participating in other experiments .Patients with parents planning to move away within the following year.
• Patients with only mildly affected MIH molars that do not require extensive restorative treatment.
• MIH-affected molars that have a very poor prognosis and require extraction.
• First permanent molars that are affected with other developmental defects, such as hypoplasia, dental fluorosis or amelogenesis imperfecta.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Direct composite restorations	preformed stainless steel crowns cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)	bulk-fill composite (Filtek BulkFlow, 3M Espe) will be used and covered using a nanohybrid composite, (Filtek XT, 3M Espe)
preformed metal crowns	preformed stainless steel crowns cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)	preformed stainless steel crowns cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)

Primary Outcome Measures

Name	Time	Method
pain after the restoration .Binary (yes or No)	12 MONTHS	questionnaire

Secondary Outcome Measures

Name	Time	Method
health-related quality of life changes by the therapies	12 months	measured as difference in Child Perceptions Questionnaire CPQ 8-10/11-14)
restoration quality Score index	12 months	(FDI criteria; criterion marginal adaptation)
Acceptability of the treatment Binary (yes or No)	12 months	questionnaire