BioHPP and Lithium Disilicate Onlay Restorations: Clinical Evaluation
Turkey (Türkiye)40 participantsStarted 2025-09-15
Plain-language 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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Modified United States Public Health Service (USPHS) Criteria