A 3-year clinical evaluation of Scotchbond Universal in non-carious cervical lesions combined with quantitative marginal analysis and optical coherence tomography

A 3-year clinical evaluation of Scotchbond Universal in non-carious cervical lesions combined with quantitative marginal analysis and optical coherence tomography - SBU-36M-NCCL-Clin-OCT

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00011084

Enrollment

Registered

2016-09-30

Start date

2014-07-01

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

erosive-abrasive lesions on tooth structures

Interventions

Group 1: Application of Scotchbond Universal after total etch of enamel and dentin with H3PO4 (etch and rinse, ER) Group 2: Application of Scotchbond Universal without previous total etch of enamel an

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patient related criteria: - must be at least 18 years of age - have signed a written informed consent prior to the first treatment Tooth related criteria: - restoration necessity of three or four non-carious cervical lesions - positive pulp status (CO2-snow) - physiological occlusal relationship with natural dentition - existing row of upper and lower anterior teeth - no abutment of trial teeth to a fixed or removable prosthesis

Exclusion criteria

Exclusion criteria: - one or two lesions per patient - no contamination control - contact to a previous restoration - periodontal pockets > 5 mm, periodontal inflammation or progression - tooth mobility > 1 - alcohol or drug abusus - patients without legal competence - pregnant women - heavy bruxism, habits - allergies to ingredients - conflicts of interests

Design outcomes

Primary

Measure	Time frame
Clinic: Evaluation according FDI criteria (Hickel et al. 2007) after 14 d, 6, 12, 24, 36 months; calculation of cumulative failure rates Optical coherence tomography (OCT): Quantification of loss of microretention/adhesion at the enamel- and dentin-cementum-composite-interface immediately after filling placement, after 14 days, 6, 12, 24 and 36 months. Follow-up examinations at 6 and 10 years were added for both clinic and OCT examinations.	—

Measure

Time frame

Clinic: Evaluation according FDI criteria (Hickel et al. 2007) after 14 d, 6, 12, 24, 36 months; calculation of cumulative failure rates Optical coherence tomography (OCT): Quantification of loss of microretention/adhesion at the enamel- and dentin-cementum-composite-interface immediately after filling placement, after 14 days, 6, 12, 24 and 36 months. Follow-up examinations at 6 and 10 years were added for both clinic and OCT examinations.

—

Secondary

Measure	Time frame
Comparison clinic vs. OCT	—

Countries

Germany

Contacts

Public ContactRainer Haak,

Universitätsklinikum Leipzig AöR, Department für Kopf- und Zahnmedizin, Poliklinik für Zahnerhaltung und Parodontologie,

rainer.haak@medizin.uni-leipzig.deOffice: +49 341 9721200

Outcome results

None listed

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