Restoration of Permanent Molars Affected With (MIH) Using Composite Restorations or Preformed Metal Crowns

Not Applicable

Completed

• Conditions: Molar Incisor Hypomineralization
• Interventions: Procedure: Direct composite restorations

• Registration Number: NCT04654858
• Lead Sponsor: Amal Ahmed Mohamed El Kot

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.

Study Timeline

• Study First Submitted: 2020-11-03
• Study First Submitted QC: 2020-12-03
• Study First Posted: 2020-12-04
• Study Start: 2021-07-04
• Primary Completion: 2023-09-03
• Study Completion: 2023-11-05
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Performed metal crowns	Direct composite restorations	PMCs (3M Espe, Seefeld, Germany) will be placed after infiltration or block anaesthesia for affected molar, followed by removal of carious dentin and enamel, Tooth preparation for fitting the crown, The correct size of crown will be chosen, and then Cemented with glass ionomer luting cement (KetacCem, 3M Espe).
Direct composite restorations	Direct composite restorations	bulk-fill composite (Filtek BulkFlow, 3M Espe) will be used after 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).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Acceptability of the treatment	12 month	Questioning the children or parents about accepting the treatment Binary (Yes or No)

Trial Locations

Locations (1)

Faculty of Oral and Dental Medicine; 🇪🇬 Cairo, Egypt