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Randomised controlled clinical trial on timing versus 3D-accuracy of fast-set impression materials

Clinical trial of the influence of time on the three-dimensional accuracy of fast-set polyether and fast-set polyvinyl siloxane impression materials

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN73608522
Enrollment
104
Registered
2008-07-31
Start date
2004-08-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Fitting precision of fixed dental restorations Surgery Dental procedure

Interventions

The study gains information on the dependency between mixing timing of a one-stage putty-and-wash dental impression and three-dimensional precision of the resulting gypsum models under clinical condit

Sponsors

3M ESPE AG (Germany)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Suitable probands were aged between 18 and 80 years, either sex, and showed a complete set of either healthy or restored teeth in the lower right quadrant up to the second molar.

Exclusion criteria

Exclusion criteria: 1. Alcohol or drug dependence 2. Persons with restricted legal capacity 3. Pregnant women 4. Probands who would face a conflict of interest due to the participation in another study 5. Patients with periodontal disease (periodontal screening index greater than 2) 6. Probands with missing teeth in the according quadrant (except for third molars and orthodontically closed spaces) 7. Probands excluded from the dental education course because of an infectious disease such as hepatitis or acquired immune deficiency syndrome (AIDS)

Design outcomes

Primary

MeasureTime frame
The precision of the three-dimensional (3D) tooth surface reproduction and the reproduction of the subgingival tooth surface, measured within 24 hours after impression taking.

Secondary

MeasureTime frame
1. Influence of environment temperature, measured in the impression session 2. Timing, measured in the impression session 3. Tray size, measured in the impression session 4. Accordance with subjective clinical impression rating, measured within four weeks after the impression session has taken place, throughout the study

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026