BioHPP and Lithium Disilicate Onlay Restorations: Clinical Evaluation

NCT07142031 | Active Not Recruiting

• 1 other identifier: Ege-DHF-AGT-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Caries; Polymers

Keywords

Polyetheretherketones; Dental Porcelain; Dental Restoration, permanent; Computer-Aided Design

Outcome Measures

Primary Outcomes (1)

• 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.

  one year

Study Arms (2)

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.

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.

Other: Lithium Disilicate

Interventions

BioHPP OTHER

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.

BioHPP Onlay Restorations: Clinical Evaluation

Lithium Disilicate OTHER

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.

Lithium Disilicate Onlay Restorations: Clinical Evaluation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Ege University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Ege University Faculty of Dentistry

Izmir, Bornova, 35030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Caries

Interventions

lithia disilicate

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Prof.

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: August 26, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)