Periodontitis Dental devices, home care Dental plaque Oral hygiene Periodontitis
Conditions
Interventions
This study does not involve a pharmaceutical or investigational medical device. A study phase is indicated due to form requirements only.
*Timeline - 3 time points over 24 weeks
*Toothbrushing twice d
the instructions will also be provided in the form of take-home pamphlets and re-emphasised during the participants'
12- and 24-week visits
*Adherence to the intervention will be assessed via a daily log of oral home care procedures kept by participants
*Full-mouth professional mechanical plaque removal (PMPR) and s
Experimental Device,Active Comparator Other
Oral irrigator,Interdental brushes
Sponsors
Auckland University of Technology
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Individuals will be eligible to participate in the study if they: 1. Are between 18 and 80 years old with a diagnosis of generalised stage I, II, or III periodontitis. 2. Have a minimum of 20 natural scoreable teeth (not covered with crowns or other extensive restorations, not including third molars). 3. Agree to delay elective dental treatment and dental cosmetic procedures. 4. Agree not to use non-study dental devices or oral care products, return for scheduled visits, and engage with study procedures. 5. Have the capacity to provide informed consent.
Exclusion criteria
Exclusion criteria: 1. Non-consent. 2. Unavailability for the study duration. 3. Systemic diseases affecting periodontal health (individuals presenting with oral consequences of systemic diseases or systemic diseases likely to affect oral health and periodontal treatment, such as chronic inflammatory conditions - uncontrolled diabetes mellitus with HbA1c equal or above 7.0%/53 mmol/mol, rheumatoid arthritis preventing effective oral hygiene; hematologic diseases; immunologic conditions; mucocutaneous disorders such as desquamative gingivitis). 4. Known allergy to the study oral hygiene products. 5. Physical or mental conditions affecting self-performed oral hygiene. 6. Requirement for premedication with antibiotics for dental appointments. 7. Presence of removable oral prostheses or orthodontic appliances. 8. Presence of orthodontic brackets, wires, or other appliances. 9. Presence of extensive and active carious lesions that may result in tooth loss during the study based on a non-invasive examination. 10. Current use of medications likely to affect periodontal health or outcomes of periodontal treatment, such as immunosuppressive medications, anticonvulsants, calcium channel blockers, long-term regular use of nonsteroidal anti-inflammatory medications, chemotherapeutic agents, immunotherapy medications, blood thinners. 11. History of periodontal treatment (non-surgical, i.e. professional mechanical plaque removal and subgingival instrumentation, or surgical) within the last six months. 12. Use of antibiotics within three months preceding the study. 13. A history (within the last 28 days) of smoking, or tobacco chewing. 14. Pregnant, planning pregnancy within the next six months, or breastfeeding individuals.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of recruitment and retention Recruitment rate - 48 weeks post the beginning of recruitment; retention rate - % of participants attending all of the scheduled sessions (baseline, 12-week, 24-week). Number of screened and eligible participants; Number of participants recruited within the specified time frame; percentage of participants who attended 12- and 24-week follow-up visits. | — |
Secondary
| Measure | Time frame |
|---|---|
| Bleeding on Probing (BOP) effect size estimation Baseline, 12 weeks post commencement of intervention (primary timepoint), 24 weeks post commencement of intervention. BOP will be recorded dichotomously as present or absent. The proportion of bleeding sites at the participant level will be calculated. | — |
Countries
New Zealand
Contacts
Public ContactDonnabella Lacap Bugler
Auckland University of Technology
Outcome results
None listed