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Clinical Trials/NCT05299489
NCT05299489
Completed
Not Applicable

Clinical Randomized Controlled Trial To Compare Direct and Indirect Composite Restoration in Children With Molar Incisor Hypomineralization Patients (MIH)

Damascus University1 site in 1 country20 target enrollmentOctober 15, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dental Enamel Hypoplasia
Sponsor
Damascus University
Enrollment
20
Locations
1
Primary Endpoint
Clinical evaluation of teeth restored by direct composite.
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
October 15, 2020
End Date
February 15, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Systematic or mental disorders.
  • Definitely negative or negative ratings of Frankel scale
  • Existence periapical translucence
  • Existence external or internal abnormal absorption
  • Existence swelling or fistula
  • Sensitivity to percussion
  • Existence of spontaneous or stimulant pain

Outcomes

Primary Outcomes

Clinical evaluation of teeth restored by direct composite.

Time Frame: 12 months after applying the restoration

Clinical evaluation of restored tooth was assessed according to USPHS criteria (Alpha, Bravo, Charlie) as following: Marginal Adaptation: (No crevice), (Crevice), (Fractured, missing). Marginal Discoloration: (no discoloration), (discoloration but has not penetrated along the margin), (discoloration has present along the). Secondary caries: (No evidence of caries), (Evidence of caries). Color Matching: (100% color match), (Slight mismatched), (Total mismatched). Anatomic Form: (anatomic form), (teeth partially degraded but clinically acceptable), (partially degraded but need to be replaced). Postoperative Sensitivity: (no Postoperative sensitivity), (slight sensitivity), (sever sensitivity).Retention: (no loss) (fracture or loss). Surface Texture: (no defect), (minimal defect), (severed defect).

Clinical evaluation of teeth restored by indirect composite.

Time Frame: 12 months after applying the restoration

Clinical evaluation of restored tooth was assessed according to USPHS criteria (Alpha, Bravo, Charlie) as following: Marginal Adaptation: (No crevice), (Crevice), (Fractured, missing). Marginal Discoloration: (no discoloration), (discoloration but has not penetrated along the margin), (discoloration has present along the). Secondary caries: (No evidence of caries), (Evidence of caries). Color Matching: (100% color match), (Slight mismatched), (Total mismatched). Anatomic Form: (anatomic form), (teeth partially degraded but clinically acceptable), (partially degraded but need to be replaced). Postoperative Sensitivity: (no Postoperative sensitivity), (slight sensitivity), (sever sensitivity).Retention: (no loss) (fracture or loss). Surface Texture: (no defect), (minimal defect), (severed defect).

Study Sites (1)

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