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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

Not Applicable
Recruiting
Conditions
Diseases of the oral cavity, salivary glands and jaws
Other diseases of the teeth and periodontium
Tooth loss due to accident, extraction or localized periodontal disease.
K00-K14
K08
K08.1
Diseases of oral cavity, salivary glands and jaws
Other disorders of teeth and supporting structures
Loss of teeth due to accident, extraction or local periodontal disease
Registration Number
DRKS00031763
Lead Sponsor
Charité – Universitätsmedizin Berlin Zahnärztliche Prothetik, Alterszahnmedizin und Funktionslehre
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
28
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

- 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

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Changes in oral health-related quality of life (OHIP-G53) after 7 days, 3 and 6 months
Secondary Outcome Measures
NameTimeMethod
- Discoloration of the framework<br>- Wear of the framework parts<br>- Plaque index<br>- probing depth<br>- caries status<br>- Tooth mobility <br>- Tooth elongation
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