K08.1 K00.0 K02.9 K04.9 K05.6
Conditions
Interventions
Group 1: Suty part 1: Lithium disilicate abutment (glass ceramic)
Group 2: Study part 1: Densely sintered zirkonia abutment (oxide ceramic)
Group 3: Study part 1: Titanium alloy abutment
Group 4: Stud
Sponsors
Universitätsklinikum Ulm, Zentrum für Zahn-, Mund- und Kieferheilkunde, Klinik für Zahnärztliche Prothetik
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: • Patients are between 18 and 75 years of age • Tooth space width at least 7 mm, allowing for an implant insertion before the study starts or as the case may be, state after two-stage augmentation or one-stage sinus lift or one-stage minor extend lateral augmentation • At least 3 mm gingival height • Legally capable patients with treatment need
Exclusion criteria
Exclusion criteria: • Need for major extend lateral augmentation in a one-stage procedure (meaning that two-stage bone bloc surgery can be included as well as one-stage sinus lift or minor extend lateral augmentation) • Smokers • Implant insertion using a surgical template was impossible before the study starts • Tooth space width is smaller than 7 mm (The interdental papilla would be severed during punch biopsy in this case) • Less than 3 mm gingival height in the lowest most area • Lack of informed consent • Chronic diseases • Pregnancy • Alcohol- or drug abusus • Anamnestic peculiarities, ruling out implant treatment before the study starts
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome (study part 1): • Biomolecular analysis of the enzyme activity as parameter for the healing process (PMN-elastase, MMP-8, IL-1ß, calprotectin) at baseline and 1, 2, 3, and 4 weeks after inserting the respective abutment Primary outcome (study part 2): 3-year survival of the abutment crowns: yes/no | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes (study part 1): • Histological analysis of the punch biopsy samples (kind, number and differentiation of cells, plaque accumulation) at baseline (implant exposure) and 4.5 weeks after insertion of the respective abutment made of three different materials • Clinical parameters: pocket depth (TT), Gingiva Index (GI), Plaque Index (PI), Bleeding on probing (BOP) 1,2,3 and 4 weeks after insertion of the respective abutment made of three different materials Secondary outcomes (study part 2): For 3 years (follow-up after 4 weeks, 1, 2 and 3 years) • Survival until abutment crown loss, continuous • Biological and technical complications (peri-implantitis (biological), abutment loosening (technical), screw fracture (t), loss of retention (t)) and treatment failure (implant loss (b), abutment crown fracture (t)) • Clinical parameters: pocket depth TT, Gingival Index GI, Plaque Index PI, Bleeding on Probing (BOP) and Pink Esthetic Score (PES) | — |
Countries
Germany
Contacts
Public ContactHeike Rudolph
Universitätsklinikum Ulm, Zentrum für Zahn-, Mund- und Kieferheilkunde, Klinik für Zahnärztliche Prothetik
Outcome results
None listed