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Analysis of undisturbed plaque formation, composition, and growth around dental implants

In vivo analysis of undisturbed peri-implant biofilm formation, composition, and growth in periodontally healthy and stable periodontitis patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000687796
Enrollment
3
Registered
2022-05-12
Start date
2026-07-03
Completion date
2027-09-01
Last updated
2023-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This will be the first study to analyse the formation, composition, and growth of an undisturbed peri-implant sulcular biofilm using a novel ISBC device developed by the University of Sydney. The study hypothesis is that the ISBC will allow us to analyse and compare the formation, composition, and growth of an undisturbed peri-implant sulcular biofilm in (i) periodontally healthy and (ii) stable periodontitis patients.

Interventions

Potential participants will be identified and screened by the treating specialist periodontists (Axel Spahr and Jessica O’Neill) through routine assessment of hospital patients that have been referred for implant treatment. These patients will be screened for suitability for implant treatment, as well as eligibility for this research study. Patients that fulfil the inclusion criteria will be invited to participate in the research. A personal (face-to-face) invitation with a periodontics registra

Potential participants will be identified and screened by the treating specialist periodontists (Axel Spahr and Jessica O’Neill) through routine assessment of hospital patients that have been referred for implant treatment. These patients will be screened for suitability for implant treatment, as well as eligibility for this research study. Patients that fulfil the inclusion criteria will be invited to participate in the research. A personal (face-to-face) invitation with a periodontics registrar (Judd Sher) will then be offered to interested patients where full-details and information about the study will be disclosed, as well as answering of any questions posed by the participants. Straumann bone-level implants will be placed in a 90 minute appointment as per the manufacturers instructions by a registered periodontist (Axel Spahr and Jessica O’Neill) or periodontics registrar (Judd Sher) and allowed to osseointegrate for 12-weeks. An impression will be taken for study casts once soft-tissue healing following second-stage surgery is completed, where an Implant Supported Biofilm Chamber (ISBC) and custom abutment will be fabricated. The ISBC will be fabricated using CAD-CAM and will be designed in a way where discs can be inserted into a chamber which is easily coverable with composite resin. The ISBC will be 3D-printed with a Formlabs Form 2/3B 3D-printer using a biocompatible light-cured dental resin (Dental LT Clear Resin, Formlabs) that is TGA- approved for dental applications such as occlusal splints, permanent and temporary restorations, and orthodontic appliances. Technical and safety data can be found on the manufacturer’s website: https://dental.formlabs.com/ The chamber will also consist of a channel that is directed and opens into the sulcular (interproximal) region, with to aim to allow gingival crevicular fluid (GCF), saliva and substrate to flow into the chamber. A zirconia disc with a standardised roughness will be milled and mounted in the ISBC. All ISBCs and discs will be disinfected in a 3% sodium hypochlorite solution for 10-minutes, rinsed in distilled water, and autoclaved before use. A final implant-supported prosthesis or restoration will be fabricated and inserted following completion of data collection. The patient will receive a full mouth clean (mechanical removal of plaque and calculus) with ultrasonic and airflow prior to start of each time point. Oral hygiene instructions (OHI) will also be given to the patient: toothbrushing technique and interdental care. Two discs will be inserted into the ISBC at each time point. Biofilm will be allowed to grow, and the ceramic disk will be removed atraumatically for microbiological analysis and replaced with a new disc at 1-hour, 24-hours, 2-days, 4-days, 7-days, and 14-days. Each disk insertion/removal visit will take 30 minutes. A total of 12 discs will be fabricated per participant (2 disks will be inserted into the ISBC for each timepoint). At each time point following disc removal, one disk will be used to analyse biofilm viability with confocal laser scanning microscopy (CLSM) while the other will be used to analyse bacterial composition with next generation sequencing.

Sponsors

University of Sydney
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
21 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

• Adult patients ( greater than or equal to 21 yoa) that are suitable for treatment with single-tooth dental implants, or have received a dental implant that requires a restoration, in the posterior region (non-aesthetic sites) • Periodontally healthy with no history of periodontitis or Stable Stage 2/3 Grade A/B periodontitis according to the 2017 world workshop on the classification of periodontal and peri-implant diseases and conditions (Chapple et al., 2018; Tonetti, Greenwell, & Kornman, 2018) • Good oral hygiene assessed by full-mouth bleeding and plaque score

Exclusion criteria

• Patients with an absolute contraindication to dental implant treatment including recent myocardial infarction and cerebrovascular accident, valvular prosthesis surgery, immunosuppression, bleeding issues, active treatment of malignancy, drug abuse, psychiatric illness, and intravenous bisphosphonate use • Participants with failing/compromised implants or peri-implantitis • Implant sites located in aesthetic zones, and sites that require tissue augmentation / grafting • Pregnant/lactating patients • Patients who have received antibiotics within the past 3 months • Edentulous patients

Outcome results

None listed

Source: ANZCTR · Data processed: Aug 28, 2026