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Clinical Performance of a novel Glass-ionomer Cement in Class V restorations

Clinical Performance of a novel Glass-ionomer Cement in Class V restorations - Delta5

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00026235
Enrollment
70
Registered
2021-09-09
Start date
2021-06-01
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

K02 K03.1 K03.2

Interventions

Group 1: Class V restorations with a new conventional glass ionomer restorative material

Sponsors

DMG Dental-Material Gesellschaft mbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Teeth with defects that require placement of a Class V restoration. • Good general health and oral hygiene. • Given informed consent. • Tooth defect is cervical dentin und coronal enamel restricted • Good access, unproblematic contamination control • Tooth is not used as support for denture • Tooth does not display developmental disorder

Exclusion criteria

Exclusion criteria: • Pregnancy or breastfeeding • Known allergy/ sensitivity to resin-based materials, GIC or other materials used in this study • Participation in another study • Incapable to participate in the recall visits at the university hospital • Limited capacity to ensure sufficient oral hygiene

Design outcomes

Primary

MeasureTime frame
Survival rate after 24 months (Evaluation based on FDI criteria (Hinkel et al. 2010))

Secondary

MeasureTime frame
Evaluation of the restorations after 1, 6, 12 and 24 months using the FDI criteria. In particular, the following criteria will be used: surface luster; surface staining; color stability and translucency; anatomic form; fractures and retention; marginal adaptation; wear; patients view; postoperative (hyper-) sensitivity and tooth vitality; recurrence of caries, erosion, abfraction; periodontal response; adjacent mucosa. Caries risk will be determined after 0, 12 and 24 months.

Countries

Germany

Contacts

Public ContactFalk Schwendicke

Charité – Universitätsmedizin Berlin Abteilung Orale Diagnostik, Digitale Zahnheilkunde und Versorgungsforschung

falk.schwendicke@charite.de+49 30 450 562 556

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026