Restoration Quality in Molars Affected by Molar Incisor Hypo Mineralization

Restoration Quality in Molars Affected by Molar-incisor-hypomineralization Using Composite Restorations or Preformed Metal Crowns: Two-arm Randomized Controlled Trial.

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

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 30
• 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 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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Direct composite restorations; bulk-fill composite (Filtek BulkFlow, 3M Espe) will be used and covered using a nanohybrid composite, (Filtek XT, 3M Espe)	Procedure: 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)
Active Comparator: preformed metal crowns; preformed stainless steel crowns cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)	Procedure: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain after the restoration .Binary (yes or No)	questionnaire	12 MONTHS

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: manalf M elshiekh, MASTER, CU

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: July 31, 2019
• First Submitted That Met QC Criteria: July 14, 2020
• First Posted (Actual): July 17, 2020

Study Record Updates

• Last Update Posted (Actual): July 17, 2020
• Last Update Submitted That Met QC Criteria: July 14, 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: 01008322329

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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