Interaction of temporary and definitive prosthetic materials for implant-suprastructures with the peri-implant soft-tissue (study part1) and longevity of implant-supported, monolithic zirconia crowns (study part 2): prospective, randomized pilot study

Not Applicable

Conditions: K05.6
K08.1
K00.0
K02.9
K04.9
Loss of teeth due to accident, extraction or local periodontal disease
Anodontia
Dental caries, unspecified
Other and unspecified diseases of pulp and periapical tissues
Periodontal disease, unspecified

Registration Number: DRKS00020224

Lead Sponsor: niversitätsklinikum Ulm

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 20

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

• 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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>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 Outcome Measures