Retrospective Clinical Evaluation of Nano-hybrid-composite Denture Teeth

NCT ID: NCT05599269

Last Updated: 2025-10-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-18

Study Completion Date

2023-04-11

Brief Summary

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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.

Detailed Description

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Conditions

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Edentulous Mouth Dental Prosthesis Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

retrospective study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Examination of dentures with SR Phonares II teeth

Group Type OTHER

Examination of dentures with SR Phonares II teeth

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ivoclar Vivadent AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ivoclar Vivadent AG

Schaan, , Liechtenstein

Site Status

Countries

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Liechtenstein

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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LL5267725

Identifier Type: -

Identifier Source: org_study_id

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