Restoration Quality in Molars Affected by Molar Incisor Hypo Mineralization

NCT04475419 | Unknown

• 1 other identifier: 01008322329
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Molar Incisor Hypomineralization

Outcome Measures

Primary Outcomes (1)

• pain after the restoration .Binary (yes or No)

  questionnaire

  12 MONTHS

Secondary Outcomes (3)

• Acceptability of the treatment Binary (yes or No)

  12 months

• restoration quality Score index

  12 months

• health-related quality of life changes by the therapies

  12 months

Study Arms (2)

Direct composite restorations

ACTIVE COMPARATOR

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)

preformed metal crowns

ACTIVE COMPARATOR

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)

Interventions

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

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

Direct composite restorations; preformed metal crowns

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children with molar incisor hypo mineralization 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Molar Hypomineralization

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• manalf M elshiekh, MASTER

  CU

  STUDY CHAIR

Central Study Contacts

Eman m elmasry, PHD

CONTACT

01001651946; Mahmoued_dentist3@yahoo.com

osama M alshahawy, master

CONTACT

01001651946; Mahmoued_dentist3@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant lecturer

Model Details: parallel groups

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: July 17, 2020
• Study Start: September 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: July 17, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share