NCT07142031

BioHPP and Lithium Disilicate Onlay Restorations: Clinical Evaluation

In-Vivo Application and Clinical Evaluation of Onlay Restorations Fabricated From BioHPP Polymer and Lithium Disilicate Ceramic Materials

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Ege University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Dental Caries
• Polymers

Interventions

Type	Name	Description
OTHER	BioHPP	Onlay restorations fabricated from BioHPP polymer will be applied to 20 patients. Following the 6- and 12-month follow-ups, the collected data will be analyzed according to clinical evaluation criteria.
OTHER	Lithium Disilicate	Onlay restorations fabricated from lithium disilicate will be applied to 20 patients and will serve as the control group for comparison with the BioHPP onlay restorations. Following the 6- and 12-month follow-ups, the collected data will be analyzed according to clinical evaluation criteria.

Timeline

• Start date: 2025-09-15
• Primary completion: 2026-09-15
• Completion: 2026-10-15
• First posted: 2025-08-26
• Last updated: 2025-11-14

Locations

1 site across 1 country: Turkey (Türkiye)