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Clinical Trials in Turkey / NCT07142031
Active, not recruiting Not applicable

BioHPP and Lithium Disilicate Onlay Restorations: Clinical Evaluation

NCT07142031 · tracked via the Priya Life Science Turkey tracker
Sponsor
Ege University
Phase
Not applicable
Started
2025-09-15
Last updated
2025-11-14

Condition(s) studied

Dental CariesPolymers

Investigational drug(s) / intervention(s)

BioHPPLithium Disilicate

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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
Inclusion Criteria: * 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). Exclusion Criteria: * 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

Primary outcome measure(s)

  • Modified United States Public Health Service (USPHS) Criteria — 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.

Trial sites (1)

FacilityCityRegionStatus
Ege University Faculty of Dentistry Izmir Bornova

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07142031 on ClinicalTrials.gov ↗ ← All trials in Turkey