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

A

Amal Ahmed Mohamed El Kot

Status

Completed

Conditions

Molar Incisor Hypomineralization

Treatments

Procedure: Direct composite restorations

Study type

Interventional

Funder types

Other

Identifiers

NCT04654858
treatment of teeth with MIH

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

7 to 12 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

60 participants in 2 patient groups

Direct composite restorations
Active Comparator group
Description:
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).
Treatment:
Procedure: Direct composite restorations
Performed metal crowns
Active Comparator group
Description:
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).
Treatment:
Procedure: Direct composite restorations

Trial contacts and locations

1

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Central trial contact

amal el kot, bachelor; Prof. Dr. Eman Elmasry, Prof. Dr

Data sourced from clinicaltrials.gov

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