A new oral bacteria model using a dental implant-supported device

Not Applicable

• Conditions: peri-implant biofilm; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12622000087752
• Lead Sponsor: niversity of Sydney - Faculty of Medicine and Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-24
• Last Update Posted: 31 January 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biofilm thickness assessed by 3D reconstruction of intact subgingival biofilm using confocal scanning laser microscopy<br>[1-hour, 24-hours, 2-days, 4-days, 7-days, and 14-days after using the ISBC device]

Secondary Outcome Measures

Name	Time	Method
Microbiological composition of subgingival oral biofilm using the novel implant-supported biofilm chamber device using next generation sequencing[1-hour, 24-hours, 2-days, 4-days, 7-days, and 14-days after using the ISBC device]