None listed
Conditions
Brief summary
Dental plaque has been defined as a community of microorganisms found on oral structures are embedded in a matrix of polymers of host and bacterial origin (Marsh, 2006). The nature and complexity of oral biofilms have led to the development of various intra-oral devices and models to study the oral microbiome. In vitro biofilm models with conventional culture methods have contributed to significant advances in understanding the oral microbiota, however, the in vitro model cannot mimic the exact in vivo environment which leads to incomparable biofilm to the one found in situ (Robinson et al., 1997; Yu et al., 2017). Several techniques have been identified in the literature to harvest the dental plaque by using paper points, cotton rolls, and scalers (Abdullah et al., 2019; Prada-López et al., 2016). However, these methods mentioned above are impossible to collect all bacteria from in situ and doubtlessly disrupt the three-dimensional architecture of the biofilm (Wood et al., 1999). A rapidly developing technique for studying an undisturbed biofilm is using an intra-oral dental appliance as a biofilm collection device (Abdullah et al., 2019). However, the main shortcomings of these devices are that they are removed during mealtimes with the biofilm not being exposed to the patient’s diet, as well as no exposure to gingival crevicular fluid. The aim of the project is to develop an implant-supported device that can grow a biofilm that has a similar composition to that collected subgingivally at a natural tooth.
Interventions
The aim of the project is to develop an implant-supported device (ISBC) that can grow a biofilm that has a similar composition to that collected subgingivally at a natural tooth. The ISBC will be designed and fabricated using CAD-CAM and will be constructed in a way where a disk can be mounted/inserted into a chamber and easily covered with composite resin. Biofilm will be allowed to grow, and the disk will be removed for microbiological analysis (biofilm thickness and composition) at 1-hour, 24
The aim of the project is to develop an implant-supported device (ISBC) that can grow a biofilm that has a similar composition to that collected subgingivally at a natural tooth. The ISBC will be designed and fabricated using CAD-CAM and will be constructed in a way where a disk can be mounted/inserted into a chamber and easily covered with composite resin. Biofilm will be allowed to grow, and the disk will be removed for microbiological analysis (biofilm thickness and composition) at 1-hour, 24-hours, 2-days, 4-days, 7-days, and 14-days. A total of 12 disks will be fabricated per participant (2 disks for each timepoint). The ISBC device will be attached to an implant that has been placed at the Sydney Dental Hospital - Department of Periodontics. The device will also act as a temporary crown (cap) prior to placing the final implant-supported crown. The temporary crown is secured to the implant with a screw. The sample collection will occur at 1-hour, 24-hours, 2-days, 4-days, 7-days, and 14-days interval after the placement of the device. Furthermore, the bacteria sample from around a natural tooth on the opposite side of the mouth will be collected at each time point for comparison. The sample will be collected by Dr. Denny Luo (investigator of this research). A total of 6-visits is required where the total appointment time for each of these visits will not exceed 45-minutes. All the information collected for the study will be treated confidentially and will be stored on a secure research database (REDCap). Only the researchers named in this study will have access to it. A Data Safety Monitoring Board will oversee this study to review, at regular intervals, accumulating trial data, in order to monitor the progress of this study. The DSMB will meet after the first 3 participants and then once a month until completion of the study.
Sponsors
University of Sydney - Faculty of Medicine and Health
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
25 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
• Adults aged 25 and with dental implants present. • Medically healthy participants with no active systemic disease or medication associated with implant failure. • No active caries, periodontal or peri-implant disease • Participants need to be willing to provide informed consent and willing to participate and comply with the study requirements.
Exclusion criteria
• Participants with active systemic disease or medication associated with implant failure. Absolute contraindications include recent myocardial infarction and cerebrovascular accident, valvular prosthesis surgery, immunosuppression, bleeding issues, active treatment of malignancy, drug abuse, psychiatric illness, and intravenous bisphosphonate use. • Systemic Antibiotics within the last 3 months • Women that are pregnant or lactating. • The ISBC will be removed if any clinical signs of irritation or signs of an active peri-implant disease are present which would require immediate treatment.
Outcome results
None listed