Clinical trial NCT04658602: Restoration of Permanent Molars Affected With (MIH) Using Composite Restorations or Preformed Metal Crowns
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Molar Incisor Hypomineralization
Keywords: MIH
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-12-08
Enrollment: 30
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel groups
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain after the restoration Binary (yes or no )
timeFrame: 12 month
Secondary outcomes:
measure: Acceptability of the treatment Binary (yes or no )
timeFrame: 12 month
measure: Restoration quality score index
timeFrame: 12 month
measure: Health-related quality of life changes by the therapies
timeFrame: 12 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of oral and dental medicine,Cairo University
Study officials:
References:
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