Restoration of Permanent Molars Affected With (MIH) 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 II)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04654858

Enrollment

Registered

2020-12-04

Start date

2021-07-04

Completion date

2023-11-05

Last updated

2024-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Molar Incisor Hypomineralization

Keywords

MIH

Brief summary

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

Detailed description

Molar incisor hypomineralization can represent a serious and challenging clinical management problem. Children with MIH require higher levels of treatment needs and demonstrate considerable management problems. For most severely affected MIH molars, direct esthetic restorative materials or preformed metal crowns will be the treatments to choose between. A number of aspects which could support decision-making, however, are not clearly demarcated. First and foremost, it is not clear if both treatments are similarly acceptable for patients and providers.

Interventions

PROCEDUREDirect composite restorations

bulk-fill composite (Filtek BulkFlow, 3M Espe) will be used aftar infiltration or block anaesthesia for affected molar,following by carious tissue removal. Marginal bevelling of enamel will be performed. A universal adhesive (Scotchbond Universal, 3M Espe) will be placed after selective enamel etching A bulk-fill composite will be used and covered using a nanohybrid composite, (Filtek XT, 3M Espe).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Blinding to the child participants and legal guardian of each participating child, operator, outcome assessor and statistician.

Eligibility

Sex/Gender

ALL

Age

7 Years to 12 Years

Healthy volunteers

Inclusion criteria

1. Children with MIH in one fully erupted molar or more. 2. Age ranging from 7-12 years. 3. cooperative children 4. Good general health.

Exclusion criteria

1. patients participating in other experiments. 2. Patients with parents planning to move away within the following year. 3. Patients with only mildly affected MIH molars that do not require extensive restorative treatment. 4. MIH-affected molars that have a very poor prognosis and require extraction. 5. First permanent molars that are affected with other developmental defects, such as hypoplasia, dental fluorosis or amelogenesis imperfecta. \-

Design outcomes

Primary

Measure	Time frame	Description
Hypersensitivity	12 month	Questioning the patient and/or the parent (Clemenus et al,2017) Binary (yes, no)

Secondary

Measure	Time frame	Description
Acceptability of the treatment	12 month	Questioning the children or parents about accepting the treatment Binary (Yes or No)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026