Clinical Evaluation of Direct Composite Veneer Restorations

• Sponsor: Hacettepe University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05842590
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 4.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Molar Incisor Hypomineralization	Other: Composite Veneer Restoration	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of Direct Composite Veneer Restorations Performed in Permanent Incisors Affected by Molar-Incisor Hypomineralization
• Actual Study Start Date: Aug 2, 2022
• Anticipated Primary Completion Date: Aug 1, 2024
• Anticipated Study Completion Date: Aug 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

2. 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. 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

4. 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

5. 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

6. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 14 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hacettepe University	Ankara		Turkey

Sponsors and Collaborators

• Hacettepe University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Beste Ozgur, Assistant professor, Hacettepe University
• ClinicalTrials.gov Identifier: NCT05842590
• Other Study ID Numbers: HUDHF-Veneer
• First Posted: May 6, 2023
• Last Update Posted: May 6, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dental Enamel Hypoplasia

Study Results

No Results Posted as of May 6, 2023