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

ISRCTN ISRCTN73608522
DOI https://doi.org/10.1186/ISRCTN73608522
Secondary identifying numbers P-10199 CR 04/05
Submission date
15/04/2008
Registration date
31/07/2008
Last edited
31/07/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Ralph Luthardt
Scientific

Center of Dentistry
Department of Prosthetic Dentistry
Albert-Einstein-Allee 11
Ulm
89081
Germany

Study information

Study designPilot study and prospective, randomised clinical trial with triple-blind evaluation
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Patient information material can be found at: http://www.uniklinik-ulm.de/fileadmin/Kliniken/Zahnmedizin/ZMK2/SIMTOM/20040726_Patienteninfo_PolyQ_SQ.pdf (in German)
Scientific titleClinical trial of the influence of time on the three-dimensional accuracy of fast-set polyether and fast-set polyvinyl siloxane impression materials
Study acronymPoly Q
Study objectivesClinical studies have shown a correlation between the fitting precision of fixed dental restorations and the clinical success or survival rate. Since dental impressions mainly determine the fitting precision of fixed restorations, they play an important role. So far, the working times of impression materials have only been evaluated in-vitro. In the clinical routine, deviations from the exact timing occur very often and are either caused by an early filling of the impression tray by the dental assistance or by a delay during syringing of the light-body impression material. The clinical relevance of the exact timing gains even more importance when fast-setting impression materials with shorter working times and setting times are used.

A non-optimal timing will have an influence on the three-dimensional precision of fast-set impressions materials. Due to the kinetics of their chemical reaction, polyethers may be of advantage compared to polyvinyl siloxane impression materials.
Ethics approval(s)Ethics approval received from the Ethics Commission of the Medical Faculty Carl Gustav Carus of the Technical University Dresden on the 11th August 2004 (ref: EK 180092004)
Health condition(s) or problem(s) studiedFitting precision of fixed dental restorations
InterventionThe 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 conditions. Differences between two types of fast-set impression materials (polyether and polyvinyl siloxane) are to be analysed with a computer-aided procedure.

Three impressions were taken from the probands, after they had undergone a professional tooth cleaning, in randomised order. Either a polyether impression or a polyvinyl siloxane impression were taken under exact timing conditions and served as a reference. Two additional impressions were taken with non-optimal timing using the same impression material as for the respective reference impression. The two additional impressions were taken with two out of eight different non-optimal timings. The order in which the three impressions were taken as well as the material and the non-optimal timing were assigned to each proband according to a randomisation list. Standardised-made master-casts were digitised and the data resulting from the non-optimal timed impressions was compared to the reference. Probands were treated with fluoride gel afterwards in order to complete the benefit of the professional tooth cleaning.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Polyether, polyvinyl siloxane
Primary outcome measureThe 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 outcome measures1. 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
Overall study start date01/08/2004
Completion date31/03/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants8 for pilot study, 96 for main study
Key inclusion criteriaSuitable 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.
Key exclusion criteria1. 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)
Date of first enrolment01/08/2004
Date of final enrolment31/03/2006

Locations

Countries of recruitment

  • Germany

Study participating centre

Center of Dentistry
Ulm
89081
Germany

Sponsor information

3M ESPE AG (Germany)
Industry

Dr Timo Kuretzky
Espe Platz
Seefeld
82229
Germany

Phone +49 (0)8152 700 1376
Email timo.kuretzky@mmm.com
Website http://www.3mespe.com
ROR logo "ROR" https://ror.org/047cnmy82

Funders

Funder type

Industry

M ESPE AG (Germany) (ref: P 10 244 CR 04/01.04.04)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan