In-Vivo Application and Clinical Evaluation of Onlay Restorations Fabricated From BioHPP Polymer and Lithium Disilicate Ceramic Materials
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Modified United States Public Health Service (USPHS) Criteria
研究概览
简要总结
In this study, clinical data obtained from the in vivo evaluation of onlay restorations fabricated with CAD/CAM using modified PEEK (BioHPP Shade 2, Bredent group GmbH & Co. KG, Senden, Germany) and lithium disilicate (IPS e.max CAD, Ivoclar Vivadent, Schaan, Liechtenstein) ceramic materials will be analyzed, and the clinical outcomes will be assessed to investigate the clinical applicability of BioHPP. The clinical success of the restorations will be evaluated using established clinical evaluation criteria, specifically the modified United States Public Health Service (USPHS) criteria, focusing on parameters such as marginal adaptation, surface roughness, color match, anatomical form, and participant-reported outcomes. These restorations will be applied to molar teeth in the maxilla and mandible, provided that the teeth are vital and have no adjacent or opposing restorations. Only teeth meeting these inclusion criteria will be considered in the study.
详细描述
Patients aged between 18 and 50 years, systemically healthy, with good oral hygiene, without periodontal disease, and with at least 24 teeth present in the oral cavity (including the first permanent molars) to ensure balanced occlusal load distribution during mastication, will be included. Only patients without parafunctional habits or smoking, and in whom esthetic criteria are not a primary concern, will be enrolled. The treated tooth must be vital, with intact buccal and lingual enamel walls measuring 2-3 mm in thickness, while the mesial and distal surfaces are destroyed. Additionally, the presence of a MOD (mesio-occluso-distal) preparation in which the isthmus involves more than half of the buccolingual width of the tooth, and the tooth does not require full crown restoration, will be required. Eligible teeth include the maxillary right and left first molars (teeth 16 and 26) and second molars (teeth 17 and 27), as well as the mandibular right and left first molars (teeth 46 and 36) and second molars (teeth 47 and 37).
For standardization purposes, the onlay cavity preparation will be restricted to cases in which the buccal and lingual enamel walls remain 2-3 mm in thickness, and the isthmus covers more than half of the buccolingual width of the tooth. If these limits are exceeded during cavity preparation or if pulp perforation occurs, the necessary treatment will be provided for the respective tooth, but such cases will be excluded from the study.
The aim of the study is to overcome the limitations of in vitro studies, such as the inability to replicate intraoral conditions (oral aging, fatigue stress, diet, and microtrauma), by evaluating BioHPP onlay and lithium disilicate restorations in vivo with respect to parameters including color match, marginal discoloration, anatomical form, marginal adaptation, surface texture, and fracture. The purpose of the project is to investigate the clinical success of onlay restorations fabricated using Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM) with BioHPP and lithium disilicate ceramic (IPS e.max CAD) materials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
To eliminate predictability and minimize any potential bias, the first group will be determined using the coin toss randomization method, followed by the application of block randomization in blocks of four. After the initial four patients in the first group are completed, patient allocation to the second group will proceed in blocks of four, and the distribution of all participants will be completed according to block randomization. Neither the patients included in the study nor the evaluator will be aware of the group assignments, with only the principal investigator having knowledge of the allocation.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The teeth planned for onlay restoration (teeth numbered 16, 17, 26, 27, 36, 37, 46, and 47) with destroyed mesial and distal surfaces, but with intact buccal and lingual enamel walls of 2-3 mm thickness.
- •In the tooth to be treated, the presence of a MOD (mesio-occluso-distal) preparation where the isthmus involves more than half of the buccolingual width of the tooth, or where the distance between the fissure and cusp tip exceeds one-third of the intercuspal distance, including one or more cusps.
- •Teeth that do not require full crown restoration.
- •Absence of any other restorations on the adjacent teeth (mesial/distal) or on the opposing teeth corresponding to the tooth planned for onlay restoration.
- •Since the BioHPP polymer material used in this study is not an esthetic material and does not offer color options, only posterior teeth that do not pose esthetic concerns will be included: maxillary right and left first molars (teeth 16 and 26) and second molars (teeth 17 and 27), as well as mandibular right and left first molars (teeth 46 and 36) and second molars (teeth 47 and 37).
排除标准
- •The relevant tooth being non-vital
- •Presence of crowns on the adjacent (mesial and distal) or opposing teeth
- •Absence of proper occlusal contact of the relevant tooth
- •Patient having periodontitis
- •Patient age not within the 18-50 year range
- •Presence of bruxism in the patient
结局指标
主要结局
Modified United States Public Health Service (USPHS) Criteria
时间窗: one year
The clinical performance of the onlay restorations was evaluated using the modified USPHS (United States Public Health Service) criteria. Parameters such as color match, anatomic form, marginal integrity, surface roughness, retention, and postoperative sensitivity were assessed. Each parameter was scored using Alpha, Bravo, and Charlie ratings, where Alpha indicates optimal clinical performance, Bravo represents an acceptable level, and Charlie denotes the need for restoration correction or replacement. In this system, higher scores correspond to better clinical performance, while lower scores indicate decreased performance.
次要结局
未报告次要终点
研究者
Ayşe Gözde Türk
Associate Prof.
Ege University