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Retrospective Clinical Evaluation of Nano-hybrid-composite Denture Teeth

Retrospective Clinical Evaluation of Nano-hybrid-composite Denture Teeth SR Phonares II

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05599269
Enrollment
17
Registered
2022-10-31
Start date
2022-11-18
Completion date
2023-04-11
Last updated
2025-10-08

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

Conditions

Dental Prosthesis Failure, Edentulous Mouth

Brief summary

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.

Interventions

DEVICEExamination 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.

Sponsors

Ivoclar Vivadent AG
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

retrospective study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* informed consent signed and understood by the subject * partial or full denture with SR Phonares II teeth * dentures delivered in the internal clinic between August 2010 and August 2012 * to be able to visit the internal clinic (Exception: Patients with limited mobility are also included if another person can carry the dentures to the internal clinic of Ivoclar Vivadent AG for the examination.)

Exclusion criteria

* patient does not wear the dentures regularly * health status (physical and mental) does not allow participation.

Design outcomes

Primary

MeasureTime frameDescription
Survival Rate of Dentures With SR Phonares II Teeth10 yearsAfter a wearing time of 10 years dentures with SR Phonares II teeth were examined by a dentist

Secondary

MeasureTime frameDescription
Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties10 yearsAfter 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

Countries

Liechtenstein

Participant flow

Participants by arm

ArmCount
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.
17
Total17

Baseline characteristics

CharacteristicExamination of dentures with SR Phonares II teeth
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
16 Participants
Age, Categorical
Between 18 and 65 years
1 Participants
Age, Continuous77 years
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
17 Participants
Region of Enrollment
Liechtenstein
17 participants
Sex: Female, Male
Female
8 Participants
Sex: Female, Male
Male
9 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 17
other
Total, other adverse events
0 / 17
serious
Total, serious adverse events
0 / 17

Outcome results

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

Time frame: 10 years

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Examination of dentures with SR Phonares II teethSurvival Rate of Dentures With SR Phonares II Teeth17 Participants
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: * FDI grade 1: clinically excellent * FDI grade 2: clinically good * FDI grade 3: clinically satisfactory * FDI grade 4: clinically unsatisfactory

Time frame: 10 years

Population: 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.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Examination of dentures with SR Phonares II teethQuality of the Dentures Concerning Aesthetic, Functional and Biological Propertiesstaining teethGrade 40 Participants
Examination of dentures with SR Phonares II teethQuality of the Dentures Concerning Aesthetic, Functional and Biological Propertiesstaining teethGrade 30 Participants
Examination of dentures with SR Phonares II teethQuality of the Dentures Concerning Aesthetic, Functional and Biological Propertiesstaining teethGrade 20 Participants
Examination of dentures with SR Phonares II teethQuality of the Dentures Concerning Aesthetic, Functional and Biological Propertiesplaque accumulationGrade 216 Participants
Examination of dentures with SR Phonares II teethQuality of the Dentures Concerning Aesthetic, Functional and Biological Propertiesplaque accumulationGrade 40 Participants
Examination of dentures with SR Phonares II teethQuality of the Dentures Concerning Aesthetic, Functional and Biological Propertiesplaque accumulationGrade 11 Participants
Examination of dentures with SR Phonares II teethQuality of the Dentures Concerning Aesthetic, Functional and Biological Propertiesplaque accumulationGrade 30 Participants
Examination of dentures with SR Phonares II teethQuality of the Dentures Concerning Aesthetic, Functional and Biological Propertiescolor matchGrade 117 Participants
Examination of dentures with SR Phonares II teethQuality of the Dentures Concerning Aesthetic, Functional and Biological Propertiescolor matchGrade 20 Participants
Examination of dentures with SR Phonares II teethQuality of the Dentures Concerning Aesthetic, Functional and Biological Propertiescolor matchGrade 30 Participants
Examination of dentures with SR Phonares II teethQuality of the Dentures Concerning Aesthetic, Functional and Biological Propertiescolor matchGrade 40 Participants
Examination of dentures with SR Phonares II teethQuality of the Dentures Concerning Aesthetic, Functional and Biological PropertiesfractureGrade 40 Participants
Examination of dentures with SR Phonares II teethQuality of the Dentures Concerning Aesthetic, Functional and Biological PropertiesfractureGrade 22 Participants
Examination of dentures with SR Phonares II teethQuality of the Dentures Concerning Aesthetic, Functional and Biological PropertiesfractureGrade 110 Participants
Examination of dentures with SR Phonares II teethQuality of the Dentures Concerning Aesthetic, Functional and Biological PropertiesfractureGrade 35 Participants
Examination of dentures with SR Phonares II teethQuality of the Dentures Concerning Aesthetic, Functional and Biological Propertiesmarginal adaptationGrade 24 Participants
Examination of dentures with SR Phonares II teethQuality of the Dentures Concerning Aesthetic, Functional and Biological Propertiesmarginal adaptationGrade 112 Participants
Examination of dentures with SR Phonares II teethQuality of the Dentures Concerning Aesthetic, Functional and Biological Propertiesmarginal adaptationGrade 40 Participants
Examination of dentures with SR Phonares II teethQuality of the Dentures Concerning Aesthetic, Functional and Biological Propertiesmarginal adaptationGrade 31 Participants
Examination of dentures with SR Phonares II teethQuality of the Dentures Concerning Aesthetic, Functional and Biological Propertiesocclusal contour/wearGrade 313 Participants
Examination of dentures with SR Phonares II teethQuality of the Dentures Concerning Aesthetic, Functional and Biological Propertiesocclusal contour/wearGrade 11 Participants
Examination of dentures with SR Phonares II teethQuality of the Dentures Concerning Aesthetic, Functional and Biological Propertiesocclusal contour/wearGrade 23 Participants
Examination of dentures with SR Phonares II teethQuality of the Dentures Concerning Aesthetic, Functional and Biological Propertiesocclusal contour/wearGrade 40 Participants
Examination of dentures with SR Phonares II teethQuality of the Dentures Concerning Aesthetic, Functional and Biological Propertiespatients viewGrade 20 Participants
Examination of dentures with SR Phonares II teethQuality of the Dentures Concerning Aesthetic, Functional and Biological Propertiespatients viewGrade 116 Participants
Examination of dentures with SR Phonares II teethQuality of the Dentures Concerning Aesthetic, Functional and Biological Propertiespatients viewGrade 30 Participants
Examination of dentures with SR Phonares II teethQuality of the Dentures Concerning Aesthetic, Functional and Biological Propertiespatients viewGrade 40 Participants
Examination of dentures with SR Phonares II teethQuality of the Dentures Concerning Aesthetic, Functional and Biological Propertiesadjacent mucosaGrade 40 Participants
Examination of dentures with SR Phonares II teethQuality of the Dentures Concerning Aesthetic, Functional and Biological Propertiesadjacent mucosaGrade 115 Participants
Examination of dentures with SR Phonares II teethQuality of the Dentures Concerning Aesthetic, Functional and Biological Propertiesadjacent mucosaGrade 20 Participants
Examination of dentures with SR Phonares II teethQuality of the Dentures Concerning Aesthetic, Functional and Biological Propertiesadjacent mucosaGrade 30 Participants
Examination of dentures with SR Phonares II teethQuality of the Dentures Concerning Aesthetic, Functional and Biological Propertiesoral healthGrade 30 Participants
Examination of dentures with SR Phonares II teethQuality of the Dentures Concerning Aesthetic, Functional and Biological Propertiesoral healthGrade 114 Participants
Examination of dentures with SR Phonares II teethQuality of the Dentures Concerning Aesthetic, Functional and Biological Propertiesoral healthGrade 20 Participants
Examination of dentures with SR Phonares II teethQuality of the Dentures Concerning Aesthetic, Functional and Biological Propertiesoral healthGrade 41 Participants
Examination of dentures with SR Phonares II teethQuality of the Dentures Concerning Aesthetic, Functional and Biological Propertiessurface lustre teethGrade 12 Participants
Examination of dentures with SR Phonares II teethQuality of the Dentures Concerning Aesthetic, Functional and Biological Propertiessurface lustre teethGrade 30 Participants
Examination of dentures with SR Phonares II teethQuality of the Dentures Concerning Aesthetic, Functional and Biological Propertiessurface lustre teethGrade 215 Participants
Examination of dentures with SR Phonares II teethQuality of the Dentures Concerning Aesthetic, Functional and Biological Propertiessurface lustre teethGrade 40 Participants
Examination of dentures with SR Phonares II teethQuality of the Dentures Concerning Aesthetic, Functional and Biological Propertiesstaining teethGrade 117 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026