Randomized controlled clinical trial to compare two framework materials for the fabrication of clasp retained removable partial dentures with regard to framework wear, hygienic ability and stabilization of the residual dentition as well as oral health-related quality of life

Randomized controlled clinical trial to compare two framework materials for the fabrication of clasp retained removable partial dentures with regard to framework wear, hygienic ability and stabilization of the residual dentition as well as oral health-related quality of life - PEEK removable partial denture

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00031763

Enrollment

Registered

2023-05-17

Start date

2023-10-18

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

Diseases of the oral cavity, salivary glands and jaws

Interventions

Group 1: Fabrication and insertion of patient-specific removable partial dentures based on PEEK in 14 patients. After 6 months replacement of the PEEK-based protheses by identical removable partial de

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Patients with partial edentulism for which a removable partial denture is indicated due to their configuration - Patients who have been informed about and agree to regular follow-up appointments

Exclusion criteria

Exclusion criteria: - pregnant and breastfeeding - minors and legally incapacitated patients - Patients diagnosed with RDC/TMD with myogenic dysfunctions (e.g. myofascial pain), disc displacements (with/without reposition) or other joint diseases (arthralgia, osteoarthritis of the temporomandibular joint) - Presence of one or more of the following conditions: uncontrolled diabetes mellitus type I and II with HbA1c > 7.5%, obesity, hereditary hemorrhage predisposition with an INR >3, osteoporosis, use of bisphosphonates, smoking, poor oral hygiene, drug and alcohol addiction, condition after high-dose radiotherapy in the head and neck region. - Factors which, in the opinion of the examiner, prevent completion of the examination e.g. unreliability

Design outcomes

Primary

Measure	Time frame
Changes in oral health-related quality of life (OHIP-G53) after 7 days, 3 and 6 months	—

Secondary

Measure	Time frame
- Discoloration of the framework - Wear of the framework parts - Plaque index - probing depth - caries status - Tooth mobility - Tooth elongation	—

Countries

Germany

Contacts

Public ContactAndreas Schwitalla

Charité – Universitätsmedizin Berlin Zahnärztliche Prothetik, Alterszahnmedizin und Funktionslehre

andreas.schwitalla@charite.de+4930450662243

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026