Clinical Evaluation of Direct Composite Veneer Restorations

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Primary Purpose

Status

Active

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Composite Veneer Restoration

About this trial

This is an interventional treatment trial for Molar Incisor Hypomineralization

Eligibility Criteria

8 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Hacettepe University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Direct Composite Veneer

Arm Description

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

Outcomes

Primary Outcome Measures

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

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

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

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

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

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05842590

First Posted

April 10, 2023

Last Updated

May 1, 2023

Sponsor

Hacettepe University

1. Study Identification

Unique Protocol Identification Number

NCT05842590

Brief Title

Clinical Evaluation of Direct Composite Veneer Restorations

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

August 2, 2022 (Actual)

Primary Completion Date

August 2024 (Anticipated)

Study Completion Date

August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Molar Incisor Hypomineralization

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Direct Composite Veneer

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Composite Veneer Restoration

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame