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Evaluation Direct and Indirect Composite Restoration in Hypomineralization Molars.

D

Damascus University

Status

Completed

Conditions

Dental Caries
Dental Enamel Hypoplasia

Treatments

Other: Direct restoration
Other: Indirect restoration

Study type

Interventional

Funder types

Other

Identifiers

NCT05299489
UDDS-Pedo-10-2022

Details and patient eligibility

About

The aim of this study is to evaluate the effectiveness of direct and Indirect Composite Restoration in Children With Molar Incisor Hypomineralization Patients (MIH) and following up after 3 , 6 , 12 months (Clinically):

Group A ( Control group ): Hypomineralization molars were restored by direct composite.

Group B ( Experimental group ): Hypomineralization molars were restored by indirect composite.

Full description

Pediatric dentists face a high prevalence of MIH ranging from 3 to 40%, so it is relatively common condition that would cause treatment challenges due to severe sensitivity, breakdown of the occlusal surface, difficulty anesthesia and relatively high failure of restorations as a result of marginal breakdown of restorations.

There are many treatment options available to restore these teeth. In mild and moderate cases, they are restored using direct composite resin. In cases where teeth are severely affected, the treatment is more complicated, including stainless steel crowns and different types of full or partial indirect crowns.

Direct composite resin restorations are the treatment option in the majority of clinical cases, but in severe cases, the results of treatment are often unsatisfactory.

Indirect composite restorations are an aesthetic alternative to cast metal inlays and stainless steel crowns with minimal microleakage.

Enrollment

20 patients

Sex

All

Ages

8 to 12 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Age between 8 and 12 years.
  2. Definitely positive or positive ratings of Frank scale.
  3. The first permanent molars must achieve the following criteria: The molar must be suffering from severe demineralization and it must be restorable with composite.
  4. caries lesions include the occlusal surface and should not extend more than thirds of the thickness of dentin
  5. Absence clinical and radiographic signs which indicate pulp necrosis

Exclusion criteria

  1. Systematic or mental disorders.
  2. Definitely negative or negative ratings of Frankel scale
  3. Existence periapical translucence
  4. Existence external or internal abnormal absorption
  5. Existence swelling or fistula
  6. Sensitivity to percussion
  7. Existence of spontaneous or stimulant pain

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

20 participants in 2 patient groups

Direct composite in hypomineraliztion molars.
Experimental group
Treatment:
Other: Direct restoration
Indirect composite in hypomineraliztion molars.
Other group
Treatment:
Other: Indirect restoration

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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