Biomolecular and histological evaluation (study part 1) / Longevity of lithium disilicate abutment crowns (study part 2): prospective, randomized pilot study

Not Applicable

Recruiting

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

• Registration Number: DRKS00006555
• Lead Sponsor: niversitätsklinikum Ulm, Zentrum für Zahn-, Mund- und Kieferheilkunde, Klinik für Zahnärztliche Prothetik

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 24

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

• 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome (study part 1):<br>• 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<br><br>Primary outcome (study part 2):<br>3-year survival of the abutment crowns: yes/no

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes (study part 1):<br>• 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<br>• 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<br><br>Secondary outcomes (study part 2):<br>For 3 years (follow-up after 4 weeks, 1, 2 and 3 years)<br>• Survival until abutment crown loss, continuous<br>• 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))<br>• Clinical parameters: pocket depth TT, Gingival Index GI, Plaque Index PI, Bleeding on Probing (BOP) and Pink Esthetic Score (PES)<br>