Restoration of Permanent Molars Affected With Molar-incisor-hypomineralization (MIH) Among a Group of Egyptian Children Using Composite Restorations or Preformed Metal Crowns

Restoration of Permanent Molars Affected With Molar-incisor-hypomineralization (MIH) Among a Group of Egyptian Children Using Composite Restorations or Preformed Metal Crowns: Two-arm Randomized Controlled Trial (Part I)

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.

Study Overview

• Status: Unknown
• Conditions: Molar Incisor Hypomineralization
• Intervention / Treatment: Procedure: restoration of permanent molars affected with MIH

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children with MIH 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: direct composite restorations	Procedure: restoration of permanent molars affected with MIH; restore MIH affected molars using direct composite or preformed metal crowns
Active Comparator: preformed metal crowns	Procedure: restoration of permanent molars affected with MIH; restore MIH affected molars using direct composite or preformed metal crowns

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2020
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: April 28, 2020
• First Submitted That Met QC Criteria: April 28, 2020
• First Posted (Actual): April 30, 2020

Study Record Updates

• Last Update Posted (Actual): July 20, 2020
• Last Update Submitted That Met QC Criteria: July 17, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Tooth Abnormalities; Dental Enamel Hypoplasia
• Other Study ID Numbers: MIH restoration

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No