Retrospective Clinical Evaluation of Nano-hybrid-composite Denture Teeth

Not Applicable

Completed

• Conditions: Edentulous Mouth; Dental Prosthesis Failure
• Interventions: Device: Examination of dentures with SR Phonares II teeth

• Registration Number: NCT05599269
• Lead Sponsor: Ivoclar Vivadent AG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-20
• Study First Submitted QC: 2022-10-25
• Study First Posted: 2022-10-31
• Study Start: 2022-11-18
• Primary Completion: 2023-04-11
• Study Completion: 2023-04-11
• Results First Submitted: 2024-03-28
• Status Verified: 2025-03
• Results First Submitted QC: 2025-03-27
• Last Update Submitted: 2025-03-27
• Results First Posted: 2025-03-28
• Last Update Posted: 2025-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Examination of dentures with SR Phonares II teeth	Examination of dentures with SR Phonares II teeth	-

Primary Outcome Measures

Name	Time	Method
Survival Rate of Dentures With SR Phonares II Teeth	10 years	After a wearing time of 10 years dentures with SR Phonares II teeth were examined by a dentist

Secondary Outcome Measures

Name	Time	Method
Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties	10 years	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

Trial Locations

Locations (1)

Ivoclar Vivadent AG; 🇱🇮 Schaan, Liechtenstein