Restoration Quality in Molars Affected by Molar Incisor Hypo Mineralization

NCT ID: NCT04475419

Last Updated: 2020-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2020-12-31

Brief Summary

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

Detailed Description

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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

Conditions

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Molar Incisor Hypomineralization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

parallel groups
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Direct composite restorations

bulk-fill composite (Filtek BulkFlow, 3M Espe) will be used and covered using a nanohybrid composite, (Filtek XT, 3M Espe)

Group Type ACTIVE_COMPARATOR

preformed stainless steel crowns cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)

Intervention Type PROCEDURE

covering the affected molar with preformed metal crown cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)

preformed metal crowns

preformed stainless steel crowns cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)

Group Type ACTIVE_COMPARATOR

preformed stainless steel crowns cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)

Intervention Type PROCEDURE

covering the affected molar with preformed metal crown cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)

Interventions

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preformed stainless steel crowns cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)

covering the affected molar with preformed metal crown cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud mohamed hassan

Assisstant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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manalf M elshiekh, MASTER

Role: STUDY_CHAIR

CU

Central Contacts

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Eman m elmasry, PHD

Role: CONTACT

01001651946 ext. 12345

osama M alshahawy, master

Role: CONTACT

01001651946 ext. 12345

Other Identifiers

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01008322329

Identifier Type: -

Identifier Source: org_study_id

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