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Effectiveness and influence of Cervitec F with regard to demineralization protection and biofilm accumulation with exposed root surfaces - a clinical study with seniors

Effectiveness and influence of Cervitec F with regard to demineralization protection and biofilm accumulation with exposed root surfaces - a clinical study with seniors - CervitecF

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00011217
Enrollment
40
Registered
2017-01-11
Start date
2017-01-15
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

root caries K02

Interventions

Group 1: cervitec F (fluoride-chx varnish) varnish application on one of three randomly selected caries lesion Group 2: Placebo varnish application on one of three randomly selected caries lesion Gr

Sponsors

Ivoclar Vivadent AG
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: - ability and voluntarily choice of participation on the study - three root caries surfaces (ICDAS - RC I) on lower or upper adult anterior or praemolars teeth wich ar not situated at each other - restorativ and prothodontic treated teeth

Exclusion criteria

Exclusion criteria: - patients with significantly reduced / missing fine motor skills (oral hygiene which can not be performed independently) - not feasible investigation due to poor general condition - patients with significantly reduced salivation/ xerostomia - patients with dementia - immunosuppressed patients: transplanted organs, autoimmune disease (e.g. chronical intestine diseases, rheumatoid arthritis - hepatitis A/B/C, tuberculosis, HIV - patients with need of additional flouride application

Design outcomes

Primary

MeasureTime frame
degree of demineralization (Delta F) will be detect with QLF- measurement (quantitative lighttinduced fluorescence) at following time points: day 0 – Baseline (t0), control-/folloow up value: 2 weeks (t1), 4 weeks (t2), 12 weeks (t3), 24 weeks after Baseline (t4) and 36 week after Baseline (t5), End: 1 year after Baseline (t6)

Secondary

MeasureTime frame
Plaque accumulation (Delta R) and surface of demineralization (Delta Q) will be detect with QLF- measurement (quantitative lighttinduced fluorescence) at following time points: day 0 – Baseline (t0), control-/folloow up value: 2 weeks (t1), 4 weeks (t2), 12 weeks (t3), 24 weeks after Baseline (t4) and 36 week after Baseline (t5), End: 1 year after Baseline (t6)

Countries

Germany

Contacts

Public ContactDirk Ziebolz

Poliklinik für Zahnerhaltung und Parodontologie

dirk.ziebolz@medizin.uni-leipzig.de+493419721211

Outcome results

None listed

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