Clinical Evaluation of Direct Composite Veneer Restorations

Not Applicable

Active, not recruiting

• Conditions: Molar Incisor Hypomineralization
• Interventions: Other: Composite Veneer Restoration

• Registration Number: NCT05842590
• Lead Sponsor: Hacettepe University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-02
• Study First Submitted: 2023-04-10
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-01
• Last Update Submitted: 2023-05-01
• Study First Posted: 2023-05-06
• Last Update Posted: 2023-05-06
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Direct Composite Veneer	Composite Veneer Restoration	This is a single-arm study. Direct composite veneer restoration will be performed to all patients.

Primary Outcome Measures

Name	Time	Method
5.Change from baseline to 12 months regarding "Retention"	baseline, 3-month, 6-month,12-month	alpha: intact bravo: chipped/loss of material charlie: complete loss of crown
2.Change from baseline to 12 months regarding "Marginal adaptation"	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"	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
6.Change from baseline to 12 months regarding "Incisal wear"	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"	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"	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

Trial Locations

Locations (1)

Hacettepe University; 🇹🇷 Ankara, Turkey