Trial Outcomes & Findings for Retrospective Clinical Evaluation of Nano-hybrid-composite Denture Teeth (NCT NCT05599269)
NCT ID: NCT05599269
Last Updated: 2025-10-08
Results Overview
After a wearing time of 10 years dentures with SR Phonares II teeth were examined by a dentist
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
17 participants
Primary outcome timeframe
10 years
Results posted on
2025-10-08
Participant Flow
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
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17
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Retrospective Clinical Evaluation of Nano-hybrid-composite Denture Teeth
Baseline characteristics by cohort
| Measure |
Examination of dentures with SR Phonares II teeth
n=17 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
|
Age, Continuous
|
77 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
Liechtenstein
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 yearsAfter a wearing time of 10 years dentures with SR Phonares II teeth were examined by a dentist
Outcome measures
| Measure |
Examination of dentures with SR Phonares II teeth
n=17 Participants
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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|---|---|
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Survival Rate of Dentures With SR Phonares II Teeth
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17 Participants
|
SECONDARY outcome
Timeframe: 10 yearsPopulation: 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.
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: * FDI grade 1: clinically excellent * FDI grade 2: clinically good * FDI grade 3: clinically satisfactory * FDI grade 4: clinically unsatisfactory
Outcome measures
| Measure |
Examination of dentures with SR Phonares II teeth
n=17 Participants
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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|---|---|
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Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
surface lustre teeth · Grade 1
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2 Participants
|
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Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
surface lustre teeth · Grade 3
|
0 Participants
|
|
Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
surface lustre teeth · Grade 2
|
15 Participants
|
|
Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
surface lustre teeth · Grade 4
|
0 Participants
|
|
Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
staining teeth · Grade 1
|
17 Participants
|
|
Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
staining teeth · Grade 4
|
0 Participants
|
|
Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
staining teeth · Grade 3
|
0 Participants
|
|
Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
staining teeth · Grade 2
|
0 Participants
|
|
Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
plaque accumulation · Grade 2
|
16 Participants
|
|
Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
plaque accumulation · Grade 4
|
0 Participants
|
|
Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
plaque accumulation · Grade 1
|
1 Participants
|
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Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
plaque accumulation · Grade 3
|
0 Participants
|
|
Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
color match · Grade 1
|
17 Participants
|
|
Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
color match · Grade 2
|
0 Participants
|
|
Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
color match · Grade 3
|
0 Participants
|
|
Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
color match · Grade 4
|
0 Participants
|
|
Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
fracture · Grade 4
|
0 Participants
|
|
Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
fracture · Grade 2
|
2 Participants
|
|
Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
fracture · Grade 1
|
10 Participants
|
|
Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
fracture · Grade 3
|
5 Participants
|
|
Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
marginal adaptation · Grade 2
|
4 Participants
|
|
Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
marginal adaptation · Grade 1
|
12 Participants
|
|
Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
marginal adaptation · Grade 4
|
0 Participants
|
|
Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
marginal adaptation · Grade 3
|
1 Participants
|
|
Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
occlusal contour/wear · Grade 3
|
13 Participants
|
|
Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
occlusal contour/wear · Grade 1
|
1 Participants
|
|
Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
occlusal contour/wear · Grade 2
|
3 Participants
|
|
Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
occlusal contour/wear · Grade 4
|
0 Participants
|
|
Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
patients view · Grade 2
|
0 Participants
|
|
Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
patients view · Grade 1
|
16 Participants
|
|
Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
patients view · Grade 3
|
0 Participants
|
|
Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
patients view · Grade 4
|
0 Participants
|
|
Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
adjacent mucosa · Grade 4
|
0 Participants
|
|
Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
adjacent mucosa · Grade 1
|
15 Participants
|
|
Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
adjacent mucosa · Grade 2
|
0 Participants
|
|
Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
adjacent mucosa · Grade 3
|
0 Participants
|
|
Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
oral health · Grade 3
|
0 Participants
|
|
Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
oral health · Grade 1
|
14 Participants
|
|
Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
oral health · Grade 2
|
0 Participants
|
|
Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
oral health · Grade 4
|
1 Participants
|
Adverse Events
Examination of dentures with SR Phonares II teeth
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place