Can using a manual toothbrush connected to a smartphone app that provides guidance on improving brushing technique reduce plaque and improve gum health?

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2020
INTERVENTION: The study utilises a randomised, parallel, two‐group design. Advertisements, in the form of posters, will be placed at the dental practice one month before the start of the study. If participants would like to participate in the study they can speak to a member of the research team at the research site (local dental nurse or local dentist). The member of the research team (local dental nurse) will provide potential participants with an information sheet with further detail on the study. Potential participants interested in taking part will be provided with an appointment to return for screening and recruitment. All potential subjects will undergo a screening visit prior to the study date. Upon successful recruitment, subjects will participate in this clinical trial for 6 weeks, compromising of a baseline visit, an interim visit (at week 3) and a final examination visit (at week 6). We would expect each visit to last no more than 40 min per participant with the exception of the interim study visit which may take less time (15‐20 min) due to no clinical indices being measured. At the screening visit (Day 0 Visit), the participant will have the opportunity to discuss the study in detail with a member of the research team (local dentist). Should the participant indicate a willingness to take part, they will be asked to sign an informed consent form. The examiner (local dentist) will carry out a brief dental exam to assess if the participant meets the inclusion criteria, this examination involves the use of an overhead operating light, a dental mirror and a dental probe. Screening and Enrollment (V0), Day ‐21 to ‐7 ‐ Selection criteria applied, informed consent procedure, Medical History, Or CONDITION: Plaque and gingivitis ; Oral Health PRIMARY OUTCOME: ; 1. Plaque levels assessed using Rustogi Modified Plaque Index at baseline and 6 weeks; 2. Gingivitis level assessed visually using Modified Gingival Index (MGI) at baseline and 6 weeks; SECONDARY OUTCOME: ; 1. Brushing duration assessed using the app at baseline visit, 3 weeks and 6 weeks; 2. Surface coverage assessed using the app at baseline visit, 3 weeks and 6 weeks; 3. Brushing frequency assessed using the app at 3 weeks and 6 weeks; 4. Perceived value at the individual level through collection of patient‐reported experience measures (PREMS) using a previously validated 15‐point oral health and brushing questionnaire at baseline, 3 weeks and 6 weeks; 5. Diagnostic utility of the 3D intraoral scans for the measurement of plaque and gingivitis levels intraorally assessed using a TRIOS intraoral scanner at baseline and 6 weeks; INCLUSION CRITERIA: 1. Male and female subjects aged 18 to 65 years inclusive 2. Available for the 6‐week study duration 3. Have a smartphone and are familiar with using smartphone applications 4. Access to Wi‐Fi where they are performing oral hygiene 5. Minimum of 20 natural teeth, including 1 molar in each quadrant, with no extensive restorations present i.e. no crowns, no fillings covering multiple surfaces (excluding 3rd molars) 6. Initial gingival assessment with at least 4 bleeding sites 7. Able to read, understand and agree to the informed consent procedure 8. Able to tolerate an oral examination by a dental professional 9. Good general health
Epistemonikos ID: 27341a42071002488ee91f9c42ca648d9a2209a1
First added on: Aug 24, 2024