Clinical Evaluation of Direct Composite Veneer Restorations

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

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 Overview

• Status: Active, not recruiting
• Conditions: Molar Incisor Hypomineralization
• Intervention / Treatment: Other: Composite Veneer Restoration

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Hacettepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Direct Composite Veneer; This is a single-arm study. Direct composite veneer restoration will be performed to all patients.	Other: Composite Veneer Restoration; This is a single-arm study. Direct composite veneer Restorations will be performed to all patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2022
• Primary Completion (Anticipated): August 1, 2024
• Study Completion (Anticipated): August 1, 2024

Study Registration Dates

• First Submitted: April 10, 2023
• First Submitted That Met QC Criteria: May 1, 2023
• First Posted (Estimate): May 4, 2023

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: May 1, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Tooth Abnormalities; Dental Enamel Hypoplasia
• Other Study ID Numbers: HUDHF-Veneer

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No