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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05842590
Other study ID # HUDHF-Veneer
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 2, 2022
Est. completion date August 2024

Study information

Verified date May 2023
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 14 Years
Eligibility 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.

Study Design


Intervention

Other:
Composite Veneer Restoration
This is a single-arm study. Direct composite veneer Restorations will be performed to all patients.

Locations

Country Name City State
Turkey Hacettepe University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 1.Change from baseline to 12 months regarding "Anatomic form" 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 baseline, 3-month, 6-month,12-month
Primary 2.Change from baseline to 12 months regarding "Marginal adaptation" 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 baseline, 3-month, 6-month,12-month
Primary 3.Change from baseline to 12 months regarding "Surface roughness" 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 baseline, 3-month, 6-month,12-month
Primary 4.Change from baseline to 12 months regarding "Marginal staining" 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 baseline, 3-month, 6-month,12-month
Primary 5.Change from baseline to 12 months regarding "Retention" alpha: intact bravo: chipped/loss of material charlie: complete loss of crown baseline, 3-month, 6-month,12-month
Primary 6.Change from baseline to 12 months regarding "Incisal wear" alpha: intact bravo: wear of occlusal surface without tooth surface exposure charlie: wear of occlusal surface with tooth surface exposure baseline, 3-month, 6-month,12-month
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