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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04015427
Other study ID # 2018-414
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 27, 2018
Est. completion date April 30, 2022

Study information

Verified date June 2022
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Abstract Aim: The primary aim of this study is to test whether or not cement residues in the submucosal environment of implants lead to a change in the microbiota and induce inflammation of the periimplant tissues. Material and Methods: 24 patients in need of a single tooth replacement will be enrolled in this cross-over controlled clinical study. All patients will receive a two-piece dental implant, which will be restored with both a cemented and a screw-retained single crown. At the time of impression taking, patients will be randomized into two groups. Patients in group A will receive a screw-retained crown. Every 8 weeks microbiological samples using sterile paper points will be collected and analyzed for bacterial content by real-time PCR. Additionally, two host markers (MMP8, IL-1ß) will be determined by ELISA. Following this first period of 16 weeks, the screw-retained crown will be replaced by a new intraorally cemented crown. Cement removal will be preformed according to best clinical procedure. These crowns will again be left for another period of 16 weeks and followed up for the harvesting of microbiological samples every 8 weeks. After the second 16-week the crowns will be removed to evaluate any excess cement. All patients will be fitted with the original screw-retained crown. Clinical parameters for inflammation and probing depths will be obtained after each 16 week-period. In group B the crowns will be incorporated in a reverse pattern. During the first 16 weeks any possible cement residues will be removed according to best clinical procedure, while for the second period of 16 weeks patients will be fitted with a screw-retained single crown. Again, microbiological and clinical parameters will be obtained at the same intervals as in Group A. After the second 16 week period the screw-retained crowns will be (re-) inserted in all patients, single tooth x-rays taken and clinical baseline values obtained. Additionally, a soft tissue biopsy will be harvested at the time of insertion of the final screw-retained crown. Patients will be followed up for another 16-week period.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date April 30, 2022
Est. primary completion date April 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - - patient older than 18 years - systemically healthy subject - periodontally healthy individuals - absence of peri-implantitis - no bone loss - good oral hygiene (PCR = 20%) - healthy periodontal tissues (BoP= 20%) - patients with a single tooth gap in the posterior area of either jaw (premolars and molars) - at least 8mm in mandible; at least 6mm in maxilla (summers technique) Exclusion Criteria: - - ongoing periodontal disease - bruxism - unwilling to comply with study procedures - heavy smokers (=10 cig/d) - ongoing periodontitis/implantitis

Study Design


Related Conditions & MeSH terms


Intervention

Device:
implant crown
After the second 16 week period the screw-retained crowns will be (re-) inserted in all patients, single tooth x-rays taken and clinical baseline values obtained. Additionally, a soft tissue biopsy will be harvested at the time of insertion of the final screw-retained crown. Patients will be followed up for another 16-week period.

Locations

Country Name City State
Sweden Folktandvården Skåne Lund Skåne

Sponsors (4)

Lead Sponsor Collaborator
University of Zurich Dentsply Sirona Implants, Fölktandvården Skåne AB, Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Other Determination of additional inflammatory markers - MMP8 The collected microbiological samples will additionally be analyzed for two host markers (MMP8, IL-1ß) that will be determined by ELISA. 4 times 8 weeks
Other Determination of additional inflammatory markers - IL-1ß The collected microbiological samples will additionally be analyzed for two host markers (MMP8, IL-1ß) that will be determined by ELISA. 4 times 8 weeks
Other Radiological outcomes A single-tooth x-ray will be obtained at the time of implant placement and again at abutment connection in order to ensure sufficient osseointegration of the implant before entering the prosthetic phase. At the time of insertion of the respective reconstruction in both groups, another periapical radiograph will be obtained to ensure the fit of the reconstruction and to check for eventual cement residue. A final x-ray will be taken at insertion of the final screw-retained implant crown to serve as baseline regarding marginal bone level at the time of final crown insertion. 12 weeks pre-BL, BL and 1year post-BL
Primary Analysis of microbiological parameters Change relative percentage of gram-negative microorganisms Change BL to 16 weeks post-restoration
Secondary Histomorphometric analysis A soft tissue biopsy will be harvested at the time of insertion of the final screw-retained implant crown in all patients. The biopsies will be used for histomorphometric measurements. 32 weeks after BL
Secondary Immunohistologic analysis - putative periodontal pathogens The biopsies will be used for the determination of inflammation and infection markers applying light-microscopy. Gingival crevicular fluid (GCF) will be collected using standardized filter paper strips. A battery of 10 putative periodontal pathogens will be analyzed using real-time PCR. 32 weeks after BL
Secondary Immunohistologic analysis - MMP8 The biopsies will be used for the determination of inflammation and infection markers applying light-microscopy. Gingival crevicular fluid (GCF) will be collected using standardized filter paper strips. 32 weeks after BL
Secondary Immunohistologic analysis - IL1ß The biopsies will be used for the determination of inflammation and infection markers applying light-microscopy. Gingival crevicular fluid (GCF) will be collected using standardized filter paper strips. 32 weeks after BL
Secondary Analysis of inflammation markers on RNA-basis - (IL-4, IL-3, IL-1alfa, IL-1beta) Tissue samples will further be processed with a (ribonucleic acid) RNA solution to allow for RNA extraction. This will then be analyzed via polymerase chain reaction (PCR) to determine expression patterns of markers such as Interleukin (IL-4, IL-3, IL-1alfa, IL-1beta) and tumor necrose factor (TNF-alfa). 32 weeks after BL
Secondary Analysis of inflammation markers on RNA-basis - TNF-alfa Tissue samples will further be processed with a (ribonucleic acid) RNA solution to allow for RNA extraction. This will then be analyzed via polymerase chain reaction (PCR) to determine expression patterns of markers such as Interleukin (IL-4, IL-3, IL-1alfa, IL-1beta) and tumor necrose factor (TNF-alfa). 32 weeks after BL
Secondary Clinical parameters - Probing Depth In order to assess the inflammatory status of the peri-implant tissue, different parameters will be assessed: 1) plaque index (dichotomous values) 2) keratinized tissue width (continuous) 3) BOP (dichotomous), 4) PD (continuous), 5) recession (continuous) Every 8 weeks until 48 weeks and again at the 1-year follow-up
Secondary Clinical parameters - Bleeding-on-Probing In order to assess the inflammatory status of the peri-implant tissue, different parameters will be assessed: 1) plaque index (dichotomous values) 2) keratinized tissue width (continuous) 3) BOP (dichotomous), 4) PD (continuous), 5) recession (continuous) Every 8 weeks until 48 weeks and again at the 1-year follow-up
Secondary Clinical parameters - Plaque Index In order to assess the inflammatory status of the peri-implant tissue, different parameters will be assessed: 1) plaque index (dichotomous values) 2) keratinized tissue width (continuous) 3) BOP (dichotomous), 4) PD (continuous), 5) recession (continuous) Every 8 weeks until 48 weeks and again at the 1-year follow-up
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