"Prospective, randomized clinical split-mouth study investigating the clinical performance of CAD/CAM fabricated partial ceramic crowns inserted with a combination of self-etching adhesive and luting composite (ELX759 / Suglue-10, 3M ESPE, Seefeld) (1) with and (2) without selective enamel etching in comparison to a self-adhesive luting material (RXU2, 3M ESPE, Seefeld)"

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00003059

Enrollment

Registered

2011-04-21

Start date

2011-04-15

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

K02

Interventions

Group 1: Restorations (CEREC 3D / Vita Mark II, Vita) luted with self-adhesive system RelyX Unicem 2, 3M ESPE Group 2: Restorations (CEREC 3D / Vita Mark II, Vita) luted with combination of self-etc

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Vital posterior teeth with extended restorations or lesions with treatment need (partial ceramic crown) Placement of rubber dam possible Tooth mobility < 1 No known allergic reactions to compounds of the applied materials Consent for participation within the study Consent to participate in recall system over three years

Exclusion criteria

Exclusion criteria: Bruxism extensive periodontal lesions irreversible pain insufficient oral hygiene (PBI > 35%, API > 35%) malign tumors, HIV or other general diseases limiting life span Allergies against compounds of the materials used Alcohol or drug abuse Participation in other clinical studies

Design outcomes

Primary

Measure	Time frame
The clinical survival of partial ceramic crowns luted to the hard tooth tissues with two luting materials, one applied with and without selective enamel etching, is evaluated. Evaluation is performed at baseline, after 6 months and after 1, 2 and 3 years. Primary outcome is the criterion "restoration in situ, must not be renewed" (due to technical or biological failures requiring renewal of the restoration)	—

Measure

Time frame

The clinical survival of partial ceramic crowns luted to the hard tooth tissues with two luting materials, one applied with and without selective enamel etching, is evaluated. Evaluation is performed at baseline, after 6 months and after 1, 2 and 3 years. Primary outcome is the criterion "restoration in situ, must not be renewed" (due to technical or biological failures requiring renewal of the restoration)

—

Secondary

Measure	Time frame
The restorations are clinically evaluated according to FDI criteria (2010) at baseline, 6 months, 1, 2 and 3 years with respect to marginal adaptation, marginal discoloration, anatomic form, postoperative hypersensitivities, secondary caries.	—

Countries

Germany

Contacts

Public ContactMarianne Federlin

Poliklinik für Zahnerhaltung und Parodontologie Klinikum der Universität Regensburg

marianne.federlin@klinik.uni-regensburg.de0941 944 6024

Outcome results

None listed

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