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Clinical Evaluation of Direct Composite Veneer Restorations

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05842590
Enrollment
100
Registered
2023-05-06
Start date
2022-08-02
Completion date
2024-08-31
Last updated
2023-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Molar Incisor Hypomineralization

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.

Interventions

OTHERComposite Veneer Restoration

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

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 14 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
1.Change from baseline to 12 months regarding Anatomic formbaseline, 3-month, 6-month,12-monthalpha: 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 adaptationbaseline, 3-month, 6-month,12-monthalpha: 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 roughnessbaseline, 3-month, 6-month,12-monthalpha: 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 stainingbaseline, 3-month, 6-month,12-monthalpha: 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 Retentionbaseline, 3-month, 6-month,12-monthalpha: intact bravo: chipped/loss of material charlie: complete loss of crown
6.Change from baseline to 12 months regarding Incisal wearbaseline, 3-month, 6-month,12-monthalpha: intact bravo: wear of occlusal surface without tooth surface exposure charlie: wear of occlusal surface with tooth surface exposure

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026