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Clinical Trials/NCT05842590
NCT05842590Active, not recruitingNot Applicable

Clinical Evaluation of Direct Composite Veneer Restorations Performed in Permanent Incisors Affected by Molar-Incisor Hypomineralization

Hacettepe University1 site in 1 country100 target enrollmentStarted: August 2, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
100
Locations
1
Primary Endpoint
2.Change from baseline to 12 months regarding "Marginal adaptation"

Study Overview

Brief Summary

The objective of this research was to evaluate the clinical success of direct composite veneer restorations performed in permanent incisors affected by molar-incisor hypomineralization.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
8 Years to 14 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Cooperative children diagnosed with MIH according to European Academy of Paediatric Dentistry (EAPD) criteria
  • •Maxillary anterior teeth with MIH-caused coloring and opacity areas
  • •Fully erupted anterior teeth

Exclusion Criteria

  • •Patients and parents of patients who accept to participate.
  • •Patients who are not in cooperation with the procedure.

Arms & Interventions

Direct Composite Veneer

Experimental

This is a single-arm study. Direct composite veneer restoration will be performed to all patients.

Intervention: Composite Veneer Restoration (Other)

Outcomes

Primary Outcomes

2.Change from baseline to 12 months regarding "Marginal adaptation"

Time Frame: baseline, 3-month, 6-month,12-month

alpha: Explorer does not catch or has one-way catch when drawn across the restoration/tooth interface bravo: explorer falls into crevice drawn across the restoration/tooth interface charlie: Dentin or base is exposed along the margin

3.Change from baseline to 12 months regarding "Surface roughness"

Time Frame: baseline, 3-month, 6-month,12-month

alpha: the surface of the restoration does not have any surface defects bravo: the surface of the restoration has minimal surface defects charlie: the surface of the restoration has severe surface defects

5.Change from baseline to 12 months regarding "Retention"

Time Frame: baseline, 3-month, 6-month,12-month

alpha: intact bravo: chipped/loss of material charlie: complete loss of crown

6.Change from baseline to 12 months regarding "Incisal wear"

Time Frame: baseline, 3-month, 6-month,12-month

alpha: intact bravo: wear of occlusal surface without tooth surface exposure charlie: wear of occlusal surface with tooth surface exposure

1.Change from baseline to 12 months regarding "Anatomic form"

Time Frame: baseline, 3-month, 6-month,12-month

alpha: The general contour of the restorations follows the contour bravo: the general contour of the restoration does not follow the contour of the tooth charlie: The restoration has an overhang does

4.Change from baseline to 12 months regarding "Marginal staining"

Time Frame: baseline, 3-month, 6-month,12-month

alpha: there is no discoloration between the restorations and tooth bravo: there is discoloration on less than half of the circumferential margin charlie: there is discoloration on more than half of the circumferential margin

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Beste Ozgur

Assistant professor

Hacettepe University

Study Sites (1)

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