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Clinical performance of new materials for the manufacture and fixing of temporary crowns and bridges

Clinical performance of new materials for the manufacture and fixing of temporary crowns and bridges

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
DRKS
Registry ID
DRKS00012776
Enrollment
50
Registered
2017-11-06
Start date
2017-06-12
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

K08.9 K03.8

Interventions

Group 1: A temporary restoration is made of ProTemp 5 and cemented with Tempbond. After one week, the same restoration is cemented with the new luting cement. The comparison to the proven material (ar

Sponsors

3M Espe AG
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: The patient has to be in good general health, does not have known allergies against any study substances, needs a full coverage crown on at least one tooth, volunteers to participate in the study, has an acceptable level of oral hygiene an the study teeth has to be vital.

Exclusion criteria

Exclusion criteria: The study will exclude patients who have a known allergy to constituents of the materials used, are addicted to medication, alcohol and/ or drugs, are suffering from infectious diseases, are suffering from malignant tumors, are undergoing or have undergone radiotherapy, are pregnant or breast feeding, are not giving informed consent, are applying for renewal of a telescopic denture, that is already present

Design outcomes

Primary

MeasureTime frame
Comparison of patient satisfaction of the temporary restoration being made of Protemp 5 with patient satisfaction of temporary restorations being made of Protemp 4 (Reference data). At the end of the wearing period, patients will be asked to complete a 3M Espe-created questionnaire (based on study DRKS00000177).

Secondary

MeasureTime frame
Soft tissue reaction, clinical handling, outer shape and the number of failures of the temporary restorations being made of Protemp 5 in comparison to the data of the temporary restorations being made of Protemp 4 (Reference data) and the adhesion to the tooth stump of the restorations being fixed by the new 3M luting cement in comparison to the data of Tempbond (Reference data). Data is collected at the end of the wearing period with the help of questionnaires for the patient and the handlers (based on study DRKS00000177).

Countries

Germany

Contacts

Public ContactGesine Senker

Zentrum für Zahn-, Mund- und Kieferheilkunde Poliklinik für Zahnärztliche Prothetik

gesine.senker@dentist.med.uni-giessen.de0641/99-46162

Outcome results

None listed

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