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This retrospective study investigates the longevity of dentures with SR Phonares II teeth after a wearing period of more than 10 years.
The primary objective is to assess the survival rate of dentures with SR Phonares II teeth after more than 10 years. The secondary objectives asses the quality of the dentures concerning aesthetic, functional and biological properties.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Examination of dentures with SR Phonares II teeth | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Examination of dentures with SR Phonares II teeth | Device | The intraoral situation will be examined similar to a standard dental examination. The dentures are then removed, cleaned and examined extraoral. Pictures and an impression of the dentures are taken. |
| Measure | Description | Time Frame |
|---|---|---|
| Survival Rate of Dentures With SR Phonares II Teeth | After a wearing time of 10 years dentures with SR Phonares II teeth were examined by a dentist | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties | After a wearing time of 10 years dentures with SR Phonares II teeth were evaluated by a dentist according to adopted FDI criteria. Aesthetic properties (surface luster, surface staining, plaque accumulation, color match (to a reference), functional properties (fracture of material, marginal adaption, occlusal contour and wear, patient's view (evaluated during discussion) and biological properties (adjacent mucosa, oral health) were eveluated according the following FDI grades:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ivoclar Vivadent AG | Schaan | 9494 | Liechtenstein |
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| ID | Title | Description |
|---|---|---|
| FG000 | Examination of dentures with SR Phonares II teeth | Examination of dentures with SR Phonares II teeth: The intraoral situation will be examined similar to a standard dental examination. The dentures are then removed, cleaned and examined extraoral. Pictures and an impression of the dentures are taken. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Examination of dentures with SR Phonares II teeth | Examination of dentures with SR Phonares II teeth: The intraoral situation will be examined similar to a standard dental examination. The dentures are then removed, cleaned and examined extraoral. Pictures and an impression of the dentures are taken. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Survival Rate of Dentures With SR Phonares II Teeth | After a wearing time of 10 years dentures with SR Phonares II teeth were examined by a dentist | Posted | Count of Participants | Participants | 10 years |
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retrospective study after 10 years of dentures wear, participants assessed for a maximum of 90 minutes
As it's a retrospective study and patients were examined after 10 years in one recall, it's not possible to define a time frame over which adverse event data were collected. Recall takes a maximum of 90 minutes for each patient.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Examination of dentures with SR Phonares II teeth | Examination of dentures with SR Phonares II teeth: The intraoral situation will be examined similar to a standard dental examination. The dentures are then removed, cleaned and examined extraoral. Pictures and an impression of the dentures are taken. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. med. dent. Ronny Watzke | Ivoclar Vivadent AG | +423 235 3401 | Ronny.Watzke@ivoclar.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 19, 2022 | Sep 26, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D009066 | Mouth, Edentulous |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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retrospective study
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| 10 years |
| Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties | After a wearing time of 10 years dentures with SR Phonares II teeth were evaluated by a dentist according to adopted FDI criteria. Aesthetic properties (surface luster, surface staining, plaque accumulation, color match (to a reference), functional properties (fracture of material, marginal adaption, occlusal contour and wear, patient's view (evaluated during discussion) and biological properties (adjacent mucosa, oral health) were eveluated according the following FDI grades:
| As only the denture was made available for some examinations in the clinical investigation, it was not possible to examine the oral health of these patients. | Posted | Count of Participants | Participants | 10 years |
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| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
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| Grade 2 |
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| Grade 4 |
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| staining teeth |
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| plaque accumulation |
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| color match |
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| fracture |
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| marginal adaptation |
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| occlusal contour/wear |
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| patients view |
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| adjacent mucosa |
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| oral health |
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