Cement Excess at Single Implant Crowns Malmö/Lund
- Conditions
- Tooth LossGingivitis and Periodontal Diseases
- Interventions
- Device: implant crown
- Registration Number
- NCT04015427
- Lead Sponsor
- University of Zurich
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
-
- 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)
-
- ongoing periodontal disease
- bruxism
- unwilling to comply with study procedures
- heavy smokers (≥10 cig/d)
- ongoing periodontitis/implantitis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description cement-retained implant crown In group B the implant crowns will be incorporated in a reverse pattern. During the first 16 weeks a cemented implant crown will be inserted and 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 implant crown. Again, microbiological and clinical parameters will be obtained at the same intervals as in Group A. screw-retained implant crown Patients in group A will receive a screw-retained implant crown. Following this first period of 16 weeks, the screw-retained implant crown will be replaced by a new intraorally cemented implant crown. Cement removal will be preformed according to best clinical procedure. These implant 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 implant crowns will be removed to evaluate any excess cement. All patients will be fitted with the original screw-retained implant crown. Clinical parameters for inflammation and probing depths will be obtained after each 16 week-period.
- Primary Outcome Measures
Name Time Method Analysis of microbiological parameters Change BL to 16 weeks post-restoration Change relative percentage of gram-negative microorganisms
- Secondary Outcome Measures
Name Time Method Histomorphometric analysis 32 weeks after BL 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.
Immunohistologic analysis - IL1ß 32 weeks after BL 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.
Immunohistologic analysis - putative periodontal pathogens 32 weeks after BL 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.
Immunohistologic analysis - MMP8 32 weeks after BL 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.
Analysis of inflammation markers on RNA-basis - (IL-4, IL-3, IL-1alfa, IL-1beta) 32 weeks after BL 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).
Analysis of inflammation markers on RNA-basis - TNF-alfa 32 weeks after BL 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).
Clinical parameters - Probing Depth Every 8 weeks until 48 weeks and again at the 1-year follow-up 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)
Clinical parameters - Bleeding-on-Probing Every 8 weeks until 48 weeks and again at the 1-year follow-up 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)
Clinical parameters - Plaque Index Every 8 weeks until 48 weeks and again at the 1-year follow-up 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)
Trial Locations
- Locations (1)
Folktandvården Skåne
🇸🇪Lund, Skåne, Sweden