K02.9 K05.3 K05.1
Conditions
Interventions
Group 1: Evaluation of the handling and satisfaction with the PHD-based set, evaluation of the parameters for gingival/periodontal health over a period of 6–12 months, and evaluation of the reliabilit
Sponsors
Universitätsklinikum Heidelberg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Adults capable of giving consent - Presence of natural dentition or fixed dentures with approximal spaces - Patients who agree to participate in the study - Not physically or mentally impaired in the daily use of oral hygiene The following inclusion criteria also apply to the respective patient groups: - Periodontitis group: Presence of periodontitis stage 1-4 - Caries group: At least three active carious lesions requiring treatment - Geriatric group: At least 75 years of age and multimorbid (simultaneous presence of at least three chronic diseases) or older than 80 years
Exclusion criteria
Exclusion criteria: - Presence of orthodontic appliances - Active systematic periodontitis therapy or periodontal surgery within the last 6 months - Known allergies to dental materials and preparations - Patients who require assistance with oral hygiene at home - Use of systemic antibiotics within the last 30 days - Current nicotine use - Current pregnancy - Patients who do not meet the inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Determination of interrater reliability of dental staff using Fleiss' kappa by considering the recommended IDBs at the beginning of the study period - Determination of changes in gingival bleeding tendency and gingival health using the Gingival Bleeding Index (GBI) (Ainamo and Bay 1975) and Bleeding on Probing (BOP) (Lang et al. 1996) at the beginning of the study period, as well as after 3-6 months and after 6-12 months - Mapping of PHD distribution in the dentition for different oral conditions (caries, periodontitis, and geriatric patients) by evaluating the availability and number of brush sizes required at the beginning of the study period - PHD-based size selection: number of attempts per interdental space until the appropriate size was found and determination of interrater reliability using Fleiss' kappa at the beginning of the study period | — |
Secondary
| Measure | Time frame |
|---|---|
| - Subjective satisfaction of dental staff using a Likert scale (Likert 1932) at the beginning of the study period - Assessment of patients' oral health-related quality of life using the Oral Health Impact Profile questionnaire (John et al. 2002) at the beginning of the study period, after 3-6 months, and after 6-12 months - Oral health literacy of patients using relevant items from the Oral Health Literacy Profile questionnaire (Spinler et al. 2021) at the beginning of the study period, after 3-6 months, and after 6-12 months - Determination of the Approximal Plaque Index (Lange et al. 1977), probing depths, and attachment loss at the beginning of the study period, after 3-6 months, and after 6-12 months - Determination of the Approximal Plaque Index (Lange et al. 1977), probing depths, and attachment loss at the beginning of the study period, after 3-6 months, and after 6-12 months - Evaluation of changes in hard and soft tissue through digital monitoring using intraoral scans of both jaws at the beginning of the study period and after 6-12 months | — |
Countries
Germany
Contacts
Public ContactCornelia Frese
Universitätsklinikum Heidelberg
Outcome results
None listed