Clinical trial NCT06987448: Comparison of Semi-direct CAD/CAM Hybrid Composite Onlays With Hybrid Ceramic Onlays in Molar - Incisor Hypomineralization in Children
Official title: Comparison of Semi-direct CAD/CAM Hybrid Composite Onlays With Hybrid Ceramic Onlays in Molar - Incisor Hypomineralization in Children: A Prospective Split-mouth Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Enamel Hypoplasia
Molar-Incisor Hypomineralization (MIH)
Restoration of Permanent Molars Affected by MIH With CAD/CAM Blocks
Keywords: Molar-Incisor Hypomineralization
Pediatric Dentistry
Digital Workflow
Tooth Sensitivity
Immediate Dentin Sealing
Lead sponsor: Marmara University
Sponsor class: OTHER
Collaborators: name: Marmara University
First posted: 2025-05-23
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: Molar-Incisor Hypomineralization (MIH) is a developmental enamel defect that primarily affects the first permanent molars and frequently the incisors. It is characterized by hypomineralized enamel with increased porosity, discoloration, and a high risk of post-eruptive enamel breakdown. Affected teeth often present with significant sensitivity, posing difficulties in achieving adequate anesthesia and effective bonding during restorative procedures. As a result, the management of MIH-affected molars in pediatric patients is both complex and clinically significant.

This prospective, randomized, split-mouth clinical study was designed to compare two different CAD/CAM materials used in semi-direct onlay restorations for the treatment of MIH-affected molars in children aged 8 to 13 years. The materials under investigation were a nano-hybrid composite block (Grandio blocs, VOCO) and a polymer-infiltrated ceramic network (PICN) hybrid ceramic block (VITA Enamic, VITA Zahnfabrik).

The study enrolled 20 pediatric patients, each presenting with at least two permanent first molars affected by MIH (classified as score 2b/c or 4b/c according to the MIH-TNI criteria). Using a split-mouth design, each patient received both interventions-one molar restored with a hybrid composite block and the other with a hybrid ceramic block. Randomization was performed using a computer-generated sequence. All procedures were carried out by a trained pediatric dentistry resident under rubber dam isolation, following a standardized adhesive protocol.

The restorative process was completed in a single session and followed a fully digital workflow. Teeth were scanned intraorally using the CEREC system, and restorations were designed and milled chairside. Immediate dentin sealing (IDS) was applied prior to cementation. The internal surfaces of the restorations were prepared using appropriate surface treatments such as sandblasting or hydrofluoric acid etching followed by silane application, in accordance with the manufacturers' guidelines. Final cementation was performed using a dual-cure resin cement.

Follow-up evaluations are planned at 6, 12, and 18 months post-operatively. At each time point, clinical assessments are conducted by two calibrated, blinded evaluators using modified United States Public Health Service (USPHS) criteria. These include evaluations of marginal adaptation, surface integrity, anatomical form, marginal discoloration, and the presence of secondary caries. Additionally, thermal sensitivity is assessed using the Schiff Cold Air Sensitivity Scale to monitor changes in dentin hypersensitivity over time.

This study aims to provide comparative data on the mid-term clinical performance of two innovative restorative materials applied in MIH-affected molars using a minimally invasive, digital workflow.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Clinical performance of onlay restorations based on modified USPHS criteria
timeFrame: 6, 12, and 18 months post-treatment
Secondary outcomes:
measure: Dentin hypersensitivity assessed by the Schiff Cold Air Sensitivity Scale
timeFrame: Baseline (pre-treatment), 6 months, 12 months, and 18 months post-treatment
measure: Intra-examiner and inter-examiner agreement on clinical evaluation criteria
timeFrame: At each clinical follow-up visit (6, 12, and 18 months)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University, School of Dentistry, Department of Pediatric Dentistry. Marmara Üniversitesi Sağlık Yerleşkesi, Diş Hekimliği Fakültesi, Başıbüyük Yolu 9/3 34854 Başıbüyük / Maltepe / İSTANBUL.
Study officials:
affiliation: Marmara University, School of Dentistry, Department of Pediatric Dentistry
name: Alp Akça, Doctor of Dental Surgery (DDS)
role: PRINCIPAL_INVESTIGATOR
References: