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A single-arm clinical study on the clinical performance of PEEK fixed dental prostheses (PEEK_FDP)

A single-arm clinical study on the clinical performance of PEEK fixed dental prostheses (PEEK_FDP)

Inokoshi Masanao

Institute of Science Tokyo Hospital

1-5-45, Yushima, Bunkyo-ku, Tokyo

m.inokoshi.gerd@tmd.ac.jp

Inokoshi Masanao

Institute of Science Tokyo Hospital

1-5-45, Yushima, Bunkyo-ku, Tokyo

+81-3-5803-5565

m.inokoshi.gerd@tmd.ac.jp

Recruiting

Oct. 20, 2025

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1.Patients missing a first molar and requiring prosthodontic treatment with a three-unit fixed dental prosthesis.
2.Patients with natural teeth or fixed prostheses as the opposing teeth.
3.Patients with at least 1.0 mm to 1.5 mm of occlusal clearance in the opposing teeth.
4.Patients with occlusal support in molar regions other than the site planned for prosthodontic restoration.
5.Patients aged 18 years or older at the time of informed consent.
6.Patients who have provided written informed consent to participate in this clinical study.

1.Patients with periodontitis requiring periodontal treatment of the remaining teeth.
2.Patients with periodontal pockets of 4mm or more on the abutment teeth.
3.Patients with tooth mobility of Miller's classification grade 2 or higher on the abutment teeth.
<Miller's classification of tooth mobility>
Grade 0: Physiologic mobility within 0.2 mm
Grade 1: Slight mobility of 0.2-1 mm in the buccolingual direction
Grade 2: Moderate mobility of 1-2 mm in both buccolingual and mesiodistal directions
Grade 3: Severe mobility exceeding 2 mm in the buccolingual and mesiodistal directions, or the presence of ver tical (axial) mobility
4.Patients with less than 30% alveolar bone support of the abutment teeth.
5.Patients with apical lesions requiring treatment of the abutment teeth.
6.Patients whose planned site for prosthodontic restoration will serve as an abutment for a removable denture.
7.Patients with bruxism.
8.Patients with dementia, psychiatric disorders, or other conditions making communication difficult.
9.Patients considered as unsuitable for participation in this study by the investigators.

Both

Patients missing a first molar requiring a three-unit fixed dental prosthesis.

A PEEK fixed dental prosthesis will be fabricated and placed for patients missing a first molar and requiring prosthodontic treatment with a three-unit fixed dental prosthesis.
Patients will be recalled at 6, 12, and 24 months after the placement to evaluate the success (presence in the oral cavity without complications) and survival (presence in the oral cavity regardless of modifications) of the PEEK fixed dental prosthesis.
Additionally, patient satisfaction (VAS), oral health-related quality of life (QoL) will be evaluated, and intraoral photographs will be taken.

Fixed dental prosthesis, PEEK, clinical study

Prosthodontic rehabilitation

Dental Prosthesis, Polymers

Dental Prosthesis, Quality of Life

Success rate at 24 months after completion of prosthodontic treatment.

1.Success rate at 6 and 12 months after completion of prosthodontic treatment.
2.Survival rate at 6, 12 and 24 months after completion of prosthodontic treatment.
3.Patient satisfaction (VAS) at 6, 12, and 24 months after completion of prosthodontic treatment.
4.Oral health-related quality of life (OHIP-14) at 6, 12, and 24 months after completion of prosthodontic treatment .
<Safety Evaluation Index>
5.Incidence rate of adverse events and prosthetic complications.

+81-3-5803-4574

July. 25, 2025

No

none