K08.1 K00.0 K02.9 K04.9 K05.6
Conditions
Interventions
Group 1: Study part 1: Insertion of a provisional material for implant suprastructures (ProtempTM4, 3M Oral Care) for 8 weeks and, secondly, of a definitive material (3M™ Lava™ Esthetic Zirkoniumdiox
there are no different treatment arms
Group 2: Study part 1: Insertion of a definitive material for implant suprastructures (3M™ Lava™ Esthetic Zirkoniumdioxid, 3M Oral Care) for 8 weeks and, secondly
there are no different treatment arms
Sponsors
Universitätsklinikum Ulm
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: • 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 internal sinus lift or one-stage minor extent lateral Augmentation; • at least 2 mm gingival height; • legally competent patient with supply needs
Exclusion criteria
Exclusion criteria: • Need for major extent lateral augmentation in a one-stage procedure (meaning that two-stage bone block surgery can be included as well as internal sinus lift or minor extent lateral augmentation) • Need for application of a soft tissue transplant • 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 2 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 |
|---|---|
| Study part 1: Quantification of inflammation-associated mediators (Primary Outcome: concentration of PMN-elastase, MMP-8, IL-1ß, Calprotectin) in periimplant crevicular fluid (PICF) by biomolecular analysis; Time of investigation: 2, 4, 6, 7 and 8 weeks after the insertion of each suprastructure material Study part 2: Survival of the prosthetic implant-suprastructure; Time of investigation: 1, 2, 3, 4 and 5 years after the insertion of the definitive suprastructure | — |
Secondary
| Measure | Time frame |
|---|---|
| Study part 1: • Quantification of inflammation-cells and inflammation-associates mediators by histometrical methods (secondary outcome: cell count and number of structures, respectively, with a positive signal of the mediator), as well as the primary stage (mRNA) of inflammation-associated mediators in the prepared soft tissue samples of the peri-implant soft tissue (secondary outcome: Amount of mRNA, coding for the inflammation-associated mediators). • Clinical parameters: Gingival index (GI), Plaque Index (PI), pocket depth (PD), Bleeding on Probing (BOP) Study part 2: • Detection of biological (b) and technical (t) complications (peri-implantitis (b), fistula (b), recession (b), Crown/Abutment/Abutment-screw loosening or fracture (t)) and failure (implant loosening and failure, respectively (b), Fracture of the Crown/Abutment/Abutmentscrew or Implant (t); see "survival")) on a complication/failuresheet. • Clinical parameters: Gingival index (GI), Plaque Index (PI), pocket depth (PD), Bleeding on Probing (BOP), esthetic index | — |
Countries
Germany
Contacts
Public ContactKatharina Kuhn
Universitätsklinikum Ulm, Klinik für Zahnärztliche Prothetik
Outcome results
None listed