Restoration Quality in Molars Affected by Molar Incisor Hypo Mineralization

Molar Incisor Hypomineralization Clinical Trial

Official title:

Restoration Quality in Molars Affected by Molar-incisor-hypomineralization Using Composite Restorations or Preformed Metal Crowns: Two-arm Randomized Controlled Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04475419
• Other study ID #: 01008322329
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2020
• Source: Cairo University
• Contact: Eman m elmasry, PHD
• Phone: 01001651946
• Email: Mahmoued_dentist3[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Restoration quality of molars affected by MIH using two different types of restorations direct composite and preformed crowns

Description:

MIH or molar incisor hypomineralization is one of the difficult clinical situations to be managed by dentists the aim of this study is to specify which is the better treatment among composite restorations and preformed crowns in terms of gingival health patient satisfaction pain hypersensetivity acceptability by the patienat hypersensetivity and the need for future retreatment

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

Inclusion Criteria:

.Children with molar incisor hypo mineralization in one fully erupted molar or more.

• Age ranging from 7-12 years.

• Cooperative children

• Good general health

Exclusion Criteria:

• Patients participating in other experiments .Patients with parents planning to move away within the following year.

• Patients with only mildly affected MIH molars that do not require extensive restorative treatment.

• MIH-affected molars that have a very poor prognosis and require extraction.

• First permanent molars that are affected with other developmental defects, such as hypoplasia, dental fluorosis or amelogenesis imperfecta.

Related Conditions & MeSH terms

• Dental Enamel Hypoplasia
• Molar Incisor Hypomineralization

Intervention

Procedure:
• preformed stainless steel crowns cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)
covering the affected molar with preformed metal crown cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain after the restoration .Binary (yes or No)	questionnaire	12 MONTHS
Secondary	Acceptability of the treatment Binary (yes or No)	questionnaire	12 months
Secondary	restoration quality Score index	(FDI criteria; criterion marginal adaptation)	12 months
Secondary	health-related quality of life changes by the therapies	measured as difference in Child Perceptions Questionnaire CPQ 8-10/11-14)	12 months