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Prospective randomized and controlled evaluation of immunological parameters at teeth, zirconia ceramic implants and titanium implants with split-mouth design in humans

Prospective randomized and controlled evaluation of immunological parameters at teeth, zirconia ceramic implants and titanium implants with split-mouth design in humans

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
DRKS
Registry ID
DRKS00026140
Enrollment
20
Registered
2021-08-25
Start date
2022-04-12
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

K05.6

Interventions

Group 1: Insertion of titanium implant, one week, 3, 6, 12 and 24 months after prosthetic restoration Examination of the sulcus fluid for various cytokines and bone markers Group 2: Insertion of zirco

Sponsors

Oral Reconstruction Foundation
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to No maximum

Inclusion criteria

Inclusion criteria: Male and female persons with a minimum age of 20 years (as well as full legal capacity (§§ 2 BGB)). The subject must have voluntarily signed the informed consent form before starting the study. The patient was informed about the follow-up examinations relevant to the study and consents to participate in them. Non-smokers and smokers <20 cigarettes / day Good oral hygiene and patient plaque control (FMPS = 25%)

Exclusion criteria

Exclusion criteria: Systemic disease that would interfere with dental implant therapy (e.g. diabetes mellitus not ceased or immunosuppression) Mucosal diseases (e.g. erosive lichen planus) History of local radiation therapy Current untreated periodontal disease or gingivitis Untreated endodontic lesions Probing the pocket depth of = 4mm on one of the teeth immediately next to the dental implant bed. Severe fractures or bruxism (clenching of the teeth, grinding) Patients with inadequate oral hygiene or who are unmotivated to perform adequate dental care at home. Patients who smoke heavily (> 20 cigarettes / day) or who consume chewing tobacco. Conditions and circumstances that, in the opinion of the study director or his deputy, the completion of the study participation and the analysis of the study results would hinder (e.g. previous history of non-compliance and / or unreliability). Physical or mental disabilities that would affect the ability to maintain proper oral hygiene. Pregnant or breastfeeding women allergic diathesis for titanium or zirconium dioxide

Design outcomes

Primary

MeasureTime frame
Immunological evaluations of the sulcus fluid compared to clinical parameters on natural teeth, zirconia ceramic implants and titanium implants over a period of two years

Secondary

MeasureTime frame
BOP on natural teeth, zirconia ceramic implants and titanium implants over a period of two years

Countries

Germany

Contacts

Public ContactGerhard Iglhaut

UNIVERSITÄTSKLINIKUM FREIBURGDepartment für Zahn-, Mund- und KieferheilkundeKlinik für Mund-, Kiefer- und Gesichtschirurgie/Plastische Operationen

gerhard.iglhaut@uniklinik-freiburg.de0761 270 49820

Outcome results

None listed

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