Clinical Comparison of CAD/CAM Nanohybrid Composite and Hybrid Ceramic Overlays in Children With Molar-Incisor Hypomineralisation

NCT06987448 | Completed

• 1 other identifier: MUPEDDENTALPAKCA
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study was conducted to compare two different dental materials used in the treatment of children who have a condition called molar-incisor hypomineralization (MIH). MIH affects the quality of the enamel in permanent molars and can cause sensitivity, pain, and rapid tooth breakdown. In this study, children between the ages of 8 and 13 who had MIH in at least two molars received two types of onlay restorations: one made from a hybrid composite block and the other from a hybrid ceramic block. Both restorations were designed and manufactured using a digital system called CAD/CAM, which allows for more precise and efficient dental treatment. Each child received both types of restorations-one on each side of the mouth-in a split-mouth design. The goal was to see how well each material worked over a period of six months. The restorations were evaluated by trained dentists using clinical criteria, and the children were also assessed for tooth sensitivity using a cold air test. The main purpose of this study was to find out which material provides better clinical performance and reduces tooth sensitivity more effectively.

Conditions

Restoration of Permanent Molars Affected by MIH With CAD/CAM Blocks; Enamel Hypoplasia; Molar-Incisor Hypomineralization (MIH)

Keywords

Molar-Incisor Hypomineralization; Pediatric Dentistry; Digital Workflow; Tooth Sensitivity; Immediate Dentin Sealing

Outcome Measures

Primary Outcomes (1)

• Clinical performance of onlay restorations based on modified USPHS criteria

  Assessment of the clinical acceptability of CAD/CAM-fabricated semi-direct onlay restorations using modified United States Public Health Service (USPHS) criteria, including Surface luster/roughness, Surface and marginal staining, Color match, Anatomic form, Fracture of restoration, Marginal adaptation, Patient's view, Postop. hypersensitivity and tooth vitality, Recurrence of erosion/caries and Fracture of tooth Scores: Acceptable: 1. Perfect 2. Good 3. Acceptable Unacceptable (failed): 4. Bad 5. Gross

  6, 12, and 18 months post-treatment

Secondary Outcomes (2)

• Dentin hypersensitivity assessed by the Schiff Cold Air Sensitivity Scale

  Baseline (pre-treatment), 6 months, 12 months, and 18 months post-treatment

• Intra-examiner and inter-examiner agreement on clinical evaluation criteria

  At each clinical follow-up visit (6, 12, and 18 months)

Study Arms (2)

Hybrid Composite Block Group (HCB)

EXPERIMENTAL

In this group, semi-direct onlay restorations were applied using nano-ceramic hybrid composite blocks (Grandio blocs, VOCO) fabricated through a CAD/CAM digital workflow. Following cavity preparation, dentin surfaces were sealed using the Immediate Dentin Sealing (IDS) technique. The restorations were cemented with a dual-cure resin cement

Procedure: Semi-direct onlay restoration using CAD/CAM hybrid ceramic block

Hybrid Ceramic Block Group (HCB)

EXPERIMENTAL

In this group, onlay restorations were fabricated from polymer-infiltrated feldspathic ceramic blocks (VITA Enamic) using a CAD/CAM-assisted digital workflow. After hydrofluoric acid etching and silane application to the internal surface of the restoration, IDS-treated tooth surfaces were prepared for cementation. Restorations were bonded using a dual-cure resin cement.

Procedure: Semi-direct onlay restoration using CAD/CAM hybrid composite block

Interventions

Semi-direct onlay restoration using CAD/CAM hybrid composite block PROCEDURE

This refers to restorations fabricated from nano-ceramic hybrid composite blocks via chairside CAD/CAM workflow and cemented to permanent molars affected by MIH (molar-incisor hypomineralization).

Hybrid Ceramic Block Group (HCB)

Semi-direct onlay restoration using CAD/CAM hybrid ceramic block PROCEDURE

This refers to restorations fabricated from polymer-infiltrated hybrid ceramic blocks using a digital workflow, then cemented to MIH-affected permanent molars.

Hybrid Composite Block Group (HCB)

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged between 8 and 13 years
• Presence of at least two permanent first molars affected by MIH
• MIH-affected molars classified as score 2b, 2c, 4b, or 4c according to the MIH-TNI index
• Symmetrical molars suitable for split-mouth comparison
• Cooperative behavior sufficient to allow treatment under local anesthesia
• Signed informed consent obtained from parent or legal guardian

You may not qualify if:

• Presence of systemic or syndromic diseases affecting enamel development
• History of bruxism or parafunctional habits
• Presence of pulp involvement, fistula, or periapical pathology in the target teeth
• Allergies to dental materials used in the study (e.g., resin-based composites, adhesives)
• Participation in another clinical trial within the past 30 days
• Inability to attend scheduled follow-up appointments at 6, 12, and 18 months
• Use of medication affecting pain perception or healing process

Sponsors & Collaborators

• Alp Akça: lead
• Marmara University: collaborator

Study Sites (1)

Marmara University, School of Dentistry, Department of Pediatric Dentistry. Marmara Üniversitesi Sağlık Yerleşkesi, Diş Hekimliği Fakültesi, Başıbüyük Yolu 9/3 34854 Başıbüyük / Maltepe / İSTANBUL.

Istanbul, Istanbul, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Enamel Hypoplasia; Molar Hypomineralization; Dentin Sensitivity

Condition Hierarchy (Ancestors)

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

Study Officials

• Alp Akça, Doctor of Dental Surgery (DDS)

  Marmara University, School of Dentistry, Department of Pediatric Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study involves the application of a hybrid composite CAD/CAM restoration to one of two permanent first molar teeth affected by MIH in each patient, and a hybrid ceramic CAD/CAM restoration to the other tooth.

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 23, 2025
• Study Start: September 11, 2023
• Primary Completion: March 15, 2024
• Study Completion: September 11, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: De-identified individual participant data (IPD), along with supporting documents such as the study protocol and statistical analysis plan, will be available beginning 6 months after publication of the primary study results and will remain available for 5 years following the publication date.
• Access Criteria: Requests for access to de-identified individual participant data and supporting documents will be considered for academic or scientific research purposes. Interested researchers must submit a written proposal detailing the planned analysis, including objectives and statistical methods. Requests will be reviewed by the principal investigator and institutional review board (IRB) representatives to ensure ethical compliance and scientific merit. A data use agreement must be signed prior to data release. Requests can be submitted via email to the corresponding author listed in the publication.

Locations

TU (1)