None listed
Conditions
Brief summary
The primary objective is to study in vivo biofilm formation, growth, and undisturbed 3-dimensional architecture on different implant abutments restorative materials in an implant-supported biofilm device. The secondary objective is to analyse and compare the microbiological composition of this biofilm grown on different implant abutments restorative materials. Study Procedures - An implant-supported biofilm device will be fabricated using CAD-CAM and will be designed in a way where a disk can be inserted inside a chamber. The chamber will also consist of a channel that is directed and opens into the sulcular and marginal (interproximal) region in order to allow gingival crevicular fluid, saliva, and substrate to flow into the chamber. - Disks of five different restorative materials (titanium, zirconia, gold, dental ceramic, and polymeric material (Polymethylmethacrylate (PMMA) or Polyetheretherketone (PEEK)) will be fabricated and mounted in the chamber. - Biofilm will be allowed to grow on each material for 14-days in a cross-over design where the first disk will be removed and then the following one will be inserted and so on. The order in which the five materials are inserted into the five participants will be randomised. - Confocal laser microscopy will be used to analyse the architecture and viability of the biofilm grown on the disks. Next-generation sequencing will be performed to analyse and compare the bacterial composition of this chamber grown biofilm on the different implant abutments restorative materials
Interventions
- An implant-supported biofilm device will be fabricated using Computer Aided Design-Computer Aided manufacturing (CAD-CAM) and will be designed in a way where a disk can be inserted inside a chamber. The chamber will also consist of a channel that is directed and opens into the sulcular and marginal (interproximal) region in order to allow gingival crevicular fluid, saliva, and substrate to flow into the chamber.
- Disks of five different restorative materials (titanium, zirconia, gold, dental
- An implant-supported biofilm device will be fabricated using Computer Aided Design-Computer Aided manufacturing (CAD-CAM) and will be designed in a way where a disk can be inserted inside a chamber. The chamber will also consist of a channel that is directed and opens into the sulcular and marginal (interproximal) region in order to allow gingival crevicular fluid, saliva, and substrate to flow into the chamber. - Disks of five different restorative materials (titanium, zirconia, gold, dental ceramic, and polymeric material (Polymethylmethacrylate (PMMA) or Polyetheretherketone (PEEK)) will be fabricated and mounted in the chamber. - Biofilm will be allowed to grow on each material for 14-days in a cross-over design where the first disk will be removed and then the following one will be inserted and so on. The order in which the five materials are inserted into the five participants will be randomised. - Confocal laser microscopy will be used to analyse the architecture and viability of the biofilm grown on the disks. Next-generation sequencing will be performed to analyse and compare the bacterial composition of this chamber grown biofilm on the different implant abutments restorative materials The observational study description: - The overall duration of observation will be 2 weeks for each Disk (each material) - At the first visit, participants will have the implant-supported biofilm device inserted with the first disk, anticipated to take 1 hour. Subsequent visits will involve removal of the previous disk and replacement with the next randomised disk, this is anticipated to take 30-60 minutes - No imaging or other dental assessments will be carried out during study visits - A registered dentist will conduct the disks insertion and removal - The study will take place at Sydney Dental Hospital, Periodontics Department. - No wash out period between the different disks is needed -The overall duration of observation will be at least 10 weeks
Sponsors
The University of Sydney
Eligibility
Sex/Gender
All
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The inclusion criteria for the potential participants include: • Adults aged 21 years and more that are suitable for dental implants treatment or have received already an implant that needs to be restored in the posterior region (non-esthetic sites). • Medically healthy without any active dental or periodontal diseases. • Good oral hygiene assessed by a full-mouth bleeding and plaque score. • Participants need to be willing to provide informed consent and willing to participate and comply with the study requirements.
Exclusion criteria
• Participants that are not eligible for dental implant treatment. Absolute contraindications to dental implant treatment 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 (Hwang & Wang, 2006). • Participants with failing/compromised implants or peri-implantitis. • Implant sites located in aesthetic zones, and sites that require tissue augmentation / grafting. • Pregnant/lactating patients • Antibiotic therapy in the last 3 months. • Completely edentulous patients
Outcome results
None listed