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

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032250444
Enrollment
20
Registered
2025-10-20
Start date
2025-11-19
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients missing a first molar requiring a three-unit fixed dental prosthesis. Fixed dental prosthesis, PEEK, clinical study

Interventions

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 recall
Dental Prosthesis, Quality of Life
Prosthodontic rehabilitation

Sponsors

Inokoshi Masanao
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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. 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.

Design outcomes

Primary

MeasureTime frame
Success rate at 24 months after completion of prosthodontic treatment.

Secondary

MeasureTime frame
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 . 5.Incidence rate of adverse events and prosthetic complications.

Contacts

Public ContactMasanao Inokoshi

Institute of Science Tokyo Hospital

m.inokoshi.gerd@tmd.ac.jp+81-3-5803-5565

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026