Clinical Evaluation of Direct Composite Veneer Restorations

Molar Incisor Hypomineralization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05842590
• Other study ID #: HUDHF-Veneer
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Dental Enamel Hypoplasia
• Molar Incisor Hypomineralization

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