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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Clinical performance of onlay restorations based on modified USPHS criteria
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Hybrid Composite Block Group (HCB)
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
干预措施: Semi-direct onlay restoration using CAD/CAM hybrid ceramic block (Procedure)
Hybrid Ceramic Block Group (HCB)
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.
干预措施: Semi-direct onlay restoration using CAD/CAM hybrid composite block (Procedure)
结局指标
主要结局
Clinical performance of onlay restorations based on modified USPHS criteria
时间窗: 6, 12, and 18 months post-treatment
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
次要结局
- 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))
研究者
Alp Akça
Principal Investigator
Marmara University