NCT05599269

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 31, 2022

Completed
18 days until next milestone

Study Start

First participant enrolled

November 18, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2023

Completed
2 years until next milestone

Results Posted

Study results publicly available

March 28, 2025

Completed
Last Updated

October 8, 2025

Status Verified

September 1, 2025

Enrollment Period

5 months

First QC Date

October 20, 2022

Results QC Date

March 28, 2024

Last Update Submit

September 26, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties

    10 years

Study Arms (1)

Examination of dentures with SR Phonares II teeth

OTHER
Device: Examination of dentures with SR Phonares II teeth

Interventions

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.

Examination of dentures with SR Phonares II teeth

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ivoclar Vivadent AG

Schaan, 9494, Liechtenstein

Location

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth Diseases

Results Point of Contact

Title
Dr. med. dent. Ronny Watzke
Organization
Ivoclar Vivadent AG

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: retrospective study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2022

First Posted

October 31, 2022

Study Start

November 18, 2022

Primary Completion

April 11, 2023

Study Completion

April 11, 2023

Last Updated

October 8, 2025

Results First Posted

March 28, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations