Dental CariesNCT07142031
BioHPP and Lithium Disilicate Onlay Restorations: Clinical Evaluation
A study testing BioHPP and Lithium Disilicate in people with Dental Caries and Polymers, run by Ege University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Dental Caries, Polymers
- What is being tested?
- BioHPP and Lithium Disilicate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2025to 15 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Faculty of Dentistry
Izmir, Bornova, 35030
About this study
Official title: In-Vivo Application and Clinical Evaluation of Onlay Restorations Fabricated From BioHPP Polymer and Lithium Disilicate Ceramic Materials
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.
Read the 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
- Being tested
- BioHPP, Lithium Disilicate
- Keywords
- Polyetheretherketones, Dental Porcelain, Dental Restoration, permanent, Computer-Aided Design
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioHPPOther
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 DisilicateOther
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 group | Role | What they receive |
|---|---|---|
| BioHPP Onlay Restorations: Clinical Evaluation | Experimental | The onlay preparation for the designated tooth of each patient included in the study will be performed using an onlay preparation bur set under water cooling with a rotary handpiece. Subsequently, digital impressions of the prepared teeth will be obtained using an intraoral scanner to facilitate the design of the onlay restorations. Following their design and fabrication, the BioHPP onlay restorations will be adhesively cemented to the teeth after verifying their fit. Receives: Other: BioHPP |
| Lithium Disilicate Onlay Restorations: Clinical Evaluation | Active comparator | The onlay preparation for the designated tooth of each patient included in the study will be performed using an onlay preparation bur set under water cooling with a rotary handpiece. Subsequently, digital impressions of the prepared teeth will be obtained using an intraoral scanner to facilitate the design of the onlay restorations. Following their design and fabrication, the Lithium Disilicate onlay restorations will be adhesively cemented to the teeth after verifying their fit. Receives: Other: Lithium Disilicate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified United States Public Health Service (USPHS) Criteria
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start15 Sep 2025
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Ayşe Gözde Türk, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142031
- Sponsor's protocol ID
- Ege-DHF-AGT-01
- Status last verified
- Nov 2025
- First submitted
- 19 Aug 2025
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The sharing of patient data was not deemed necessary.
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-Vivo Application and Clinical Evaluation of Onlay Restorations Fabricated From BioHPP Polymer and Lithium Disilicate Ceramic Materials
- ClinicalTrials.gov ID
- NCT07142031
- Acronym / sponsor ID
- Ege-DHF-AGT-01
- Conditions
- Dental Caries, Polymers
- Keywords
- Polyetheretherketones, Dental Porcelain, Dental Restoration, permanent, Computer-Aided Design
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 26 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BioHPP Onlay Restorations: Clinical Evaluation | Experimental | Other: BioHPPThe onlay preparation for the designated tooth of each patient included in the study will be performed using an onlay preparation bur set under water cooling with a rotary handpiece. Subsequently, digital impressions of the prepared teeth will be obtained using an intraoral scanner to facilitate the design of the onlay restorations. Following their design and fabrication, the BioHPP onlay restorations will be adhesively cemented to the teeth after verifying their fit. |
| Lithium Disilicate Onlay Restorations: Clinical Evaluation | Active comparator | Other: Lithium DisilicateThe onlay preparation for the designated tooth of each patient included in the study will be performed using an onlay preparation bur set under water cooling with a rotary handpiece. Subsequently, digital impressions of the prepared teeth will be obtained using an intraoral scanner to facilitate the design of the onlay restorations. Following their design and fabrication, the Lithium Disilicate onlay restorations will be adhesively cemented to the teeth after verifying their fit. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioHPPOnlay 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 | BioHPP Onlay Restorations: Clinical Evaluation |
| Lithium DisilicateOnlay 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. | Other | Lithium Disilicate Onlay Restorations: Clinical Evaluation |
Primary outcome
Modified United States Public Health Service (USPHS) Criteria
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- Individual participant dataSharing planned: No. The sharing of patient data was not deemed necessary.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioHPP and Lithium Disilicate in people with Dental Caries and Polymers, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified United States Public Health Service (USPHS) Criteria (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025; AzTrials last refreshed its copy on 2 Nov 2026.