NCT04369768

Brief Summary

The aim of this study is to compare the clinical outcome of using direct esthetic composite restorations and the use of preformed metal crowns in managing MIH cases among a group of Egyptian children.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 30, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

July 20, 2020

Status Verified

July 1, 2020

Enrollment Period

1 year

First QC Date

April 28, 2020

Last Update Submit

July 17, 2020

Conditions

Molar Incisor Hypomineralization

Outcome Measures

Primary Outcomes (1)

  • treating hypersensitivity associated with MIH affected permanent molars by questioning the patient

    questioning the patient about hypersensitivity after performing treatment ( direct composite restorations and preformed metal crowns)

    one year

Study Arms (2)

direct composite restorations

ACTIVE COMPARATOR
Procedure: restoration of permanent molars affected with MIH

preformed metal crowns

ACTIVE COMPARATOR
Procedure: restoration of permanent molars affected with MIH

Interventions

restoration of permanent molars affected with MIHPROCEDURE

restore MIH affected molars using direct composite or preformed metal crowns

direct composite restorationspreformed metal crowns

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with MIH in one fully erupted molar or more.
  • Age ranging from 7-12 years.
  • Cooperative children
  • Good general health.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Molar Hypomineralization

Condition Hierarchy (Ancestors)

Dental Enamel HypomineralizationDevelopmental Defects of EnamelTooth AbnormalitiesStomatognathic System AbnormalitiesStomatognathic DiseasesTooth DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Sandra Nasr Fares

CONTACT

01225167030dr.sandra.nasr@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Sandra Nasr Fares

Study Record Dates

First Submitted

April 28, 2020

First Posted

April 30, 2020

Study Start

July 1, 2020

Primary Completion

July 1, 2021

Study Completion

August 1, 2021

Last Updated

July 20, 2020

Record last verified: 2020-07