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

Not Applicable

• Conditions: Molar Incisor Hypomineralization
• Interventions: Procedure: Preformed stainless steal crown cemented by glass ionomer lutting cement (Ketac cem,3M Espe)

• Registration Number: NCT04658602
• Lead Sponsor: Nada Mahmoud Abd El-Azim Mohamed

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.

Study Timeline

• Study First Submitted: 2020-11-09
• Status Verified: 2020-12
• Study Start: 2020-12
• Study First Submitted QC: 2020-12-01
• Last Update Submitted: 2020-12-01
• Study First Posted: 2020-12-08
• Last Update Posted: 2020-12-08
• Primary Completion: 2021-10-01
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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
Direct composite restoration	Preformed stainless steal crown cemented by glass ionomer lutting cement (Ketac cem,3M Espe)	Bulk-fill composite (Filtek bulk flow, 3M Espe ) will be used and covered using a nanohybrid copmosite (filtek XT, 3M Espe )
Preformed metal crowns	Preformed stainless steal crown cemented by glass ionomer lutting cement (Ketac cem,3M Espe)	Preformed stainless-steal crowns cemented by glass ionomer lutting cement (ketac cem. 3M Espe )

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of oral and dental medicine,Cairo University; 🇪🇬 Cairo, Egypt