Retrospective Clinical Evaluation of Nano-hybrid-composite Denture Teeth

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

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.

Study Overview

• Status: Completed
• Conditions: Dental Prosthesis Failure; Edentulous Mouth
• Intervention / Treatment: Device: Examination of dentures with SR Phonares II teeth

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Liechtenstein
  • Schaan, Liechtenstein, 9494
    • Ivoclar Vivadent AG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Examination of dentures with SR Phonares II teeth	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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: FDI grade 1: clinically excellent; FDI grade 2: clinically good; FDI grade 3: clinically satisfactory; FDI grade 4: clinically unsatisfactory	10 years

Collaborators and Investigators

• Sponsor: Ivoclar Vivadent AG

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2022
• Primary Completion (Actual): April 11, 2023
• Study Completion (Actual): April 11, 2023

Study Registration Dates

• First Submitted: October 20, 2022
• First Submitted That Met QC Criteria: October 25, 2022
• First Posted (Actual): October 31, 2022

Study Record Updates

• Last Update Posted (Estimated): October 8, 2025
• Last Update Submitted That Met QC Criteria: September 26, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: LL5267725

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No