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 III)

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04658602

Enrollment

Registered

2020-12-08

Start date

2020-12-31

Completion date

2021-12-31

Last updated

2020-12-08

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 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

PROCEDUREPreformed stainless steal crown cemented by glass ionomer lutting cement (Ketac cem,3M Espe)

Covering the affected molar with preformed metal crown cemented by glass ionomer lutting cement

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Masking description

Quadruple ( Participant, Care Provider, Investigator, Outcomes Assessor ) Blinding to the child participants and legal guardian of each participating child, operator, outcome assessor and statistician.

Intervention model description

Parallel groups

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
Pain after the restoration Binary (yes or no )	12 month	Questionnaire

Secondary

Measure	Time frame	Description
Acceptability of the treatment Binary (yes or no )	12 month	Questionnaire
Restoration quality score index	12 month	(FDI criteria: criterion marginal adaptation
Health-related quality of life changes by the therapies	12 month	Measured as difference in child perceptions Questionnaire CPQ 8-10/11-14)

Countries

Egypt

Contacts

Primary ContactNada Mahmoud Abd el-azim Mohamed, Bachelor

nada.abdelazim@dentistry.cu.edu.eg+201126696236

Backup ContactProf.Dr.eman Elmasry, Prof.Dr.

Outcome results

None listed

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