Clinical Evaluation of Direct Composite Veneer Restorations

NCT05842590 | Unknown

• 1 other identifier: HUDHF-Veneer
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Molar Incisor Hypomineralization

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Direct Composite Veneer

EXPERIMENTAL

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

Other: Composite Veneer Restoration

Interventions

Composite Veneer Restoration OTHER

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

Direct Composite Veneer

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Patients and parents of patients who accept to participate.
• Patients who are not in cooperation with the procedure.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Molar Hypomineralization

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: May 6, 2023
• Study Start: August 2, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

TU (1)