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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
DRKS
Registry ID
DRKS00011064
Enrollment
50
Registered
2016-09-30
Start date
2016-03-01
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 K03

Interventions

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

Sponsors

Heraeus Kulzer GmbH
Lead Sponsor

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 - patients with conflicts of interests

Design outcomes

Primary

MeasureTime frame
Clinic: Evaluation according FDI criteria (Hickel et al. 2007) after 14 days, 6, 12, 24, 36 months; calculation of cumulative failure rates Optical coherence tomogaphy (OCT): Quantification of loss of microtetention/adhesion at the enamel- and dentin-cementum-composite-interface immediately after filling placement, after 14 days, 6, 12, 24, 36 months

Secondary

MeasureTime frame
Comparison clinic vs. OCT (optical coherence tomography)

Countries

Germany

Contacts

Public ContactRainer Haak

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

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

Outcome results

None listed

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