Restoration Quality in Molars Affected by Molar Incisor Hypo Mineralization

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04475419

Enrollment

Registered

2020-07-17

Start date

2020-09-01

Completion date

2020-12-31

Last updated

2020-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Molar Incisor Hypomineralization

Brief summary

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

Detailed 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

Interventions

PROCEDUREpreformed 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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Intervention model description

parallel groups

Eligibility

Sex/Gender

ALL

Age

7 Years to 12 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
pain after the restoration .Binary (yes or No)	12 MONTHS	questionnaire

Secondary

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

Contacts

Primary ContactEman m elmasry, PHD

Mahmoued_dentist3@yahoo.com01001651946

Backup Contactosama M alshahawy, master