An interventional study of Structured Preventive Care Workflow (iMGi) in Plaque-Induced Gingivitis, sponsored by Curaden AG. Not yet recruiting at 1 site in Switzerland. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Curaden AG · Not applicable, Interventional, and Health services research
Gingival inflammation is common and can often be reversed with effective daily oral hygiene. However, preventive care is not always delivered consistently in dental practices, and patients may not receive sufficient individualized training in oral self care and follow-up support.
This study will evaluate whether a structured preventive care workflow, called iMGi (individualized management of gingival inflammation), can be implemented consistently in routine dental practice.
Approximately 100 adults with plaque-related gingival inflammation will participate across multiple clinical centres. All participants will receive structured preventive care, including assessment of gingival health, individualized oral self-care training, professional preventive care, and follow-up appointments over approximately 10 months.
The main aim is to understand whether the workflow is practical for dental professionals to deliver, acceptable to patients and practitioners, and consistently applied across different clinical settings.
The researchers will also collect information on gingival bleeding, oral hygiene, patient experiences, and oral self-care behaviour to explore changes during the study.
The findings may help improve how preventive oral healthcare is organized and delivered in everyday dental practice.
This prospective, non-randomized, single-arm clinical study evaluates the implementation of a structured preventive care workflow (iMGi) for the management of plaque-related gingival inflammation in routine dental practice.
The study is designed to assess the feasibility, acceptability, fidelity, and reproducibility of the workflow across different clinical settings and dental professionals. It focuses on the integration of established preventive care procedures into a consistent clinical framework rather than testing a new therapeutic intervention.
Approximately 100 adult participants with plaque-related gingival inflammation will be recruited across multiple clinical centres. All participants will receive care according to the same structured workflow, adapted to individual clinical needs.
The workflow integrates clinical assessment, interdental bleeding evaluation using the BOB Index, individualized oral self-care training, plaque disclosure, professional mechanical plaque removal, structured follow-up planning, and digital support for patient communication and self-care.
Following screening and inclusion, participants will attend a baseline visit (T0) and subsequent follow-up visits (T1-T5) over approximately 10 months. The frequency and content of care are structured to support skill development, reassessment, and reinforcement of daily oral self-care.
Implementation will be evaluated through participant completion rates, adherence to predefined workflow steps, and feedback from patients and dental professionals. The primary endpoint concerns completion of the workflow and delivery of the planned steps.
Secondary assessments will explore clinical, behavioural, and experiential outcomes, including changes in interdental gingival bleeding measured using the BOB Index.
The study is conducted under routine clinical conditions, with descriptive analysis of implementation outcomes and exploratory analysis of longitudinal clinical changes. Findings will inform the feasibility of integrating a structured preventive care model into everyday practice and may support the design of future controlled studies.
609 studies on the registry are indexed under Gingivitis; 107 are open to participants now.
This study's planned enrollment of 100 is above the median of 63 across 494 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →This is the only study on the registry with Curaden AG as lead sponsor.
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Exclusion Criteria:
Participants receive routine preventive dental care delivered according to the structured iMGi workflow for plaque-related gingival inflammation. The workflow integrates clinical assessment, BOB Index evaluation, individualized oral self-care training, plaque disclosure, professional mechanical plaque removal, structured follow-up planning, and digital patient support. All participants follow the same workflow, with assessments from baseline (T0) through T5 over approximately 10 months.
Behavioral: Structured Preventive Care Workflow (iMGi)
A structured preventive care workflow integrating established clinical procedures with individualized oral self-care training and longitudinal follow-up. The workflow includes assessment of gingival health, BOB Index evaluation with calibrated interdental brushes, individualized patient training, plaque disclosure, professional mechanical plaque removal, follow-up planning, and digital support. It is designed to facilitate consistent delivery of preventive care in routine dental practice and does not introduce a new therapeutic procedure.
Participant Completion of the iMGi Workflow
Proportion of enrolled participants who complete the full structured preventive care workflow, including the scheduled visits from baseline (T0) through the final follow-up (T5). Calculated as the number of participants completing the workflow divided by the total number of enrolled participants, expressed as a percentage.
Time frame: From baseline (T0) to final follow-up (T5), approximately 10 months
Adherence to Predefined iMGi Workflow Steps
Proportion of study visits during which all predefined steps of the structured iMGi preventive care workflow are performed as planned. Calculated as the number of visits with complete adherence to the predefined workflow steps divided by the total number of evaluable visits, expressed as a percentage.
Time frame: Across study visits from T0 through T5, approximately 10 months
Change in Bleeding on Interdental Brushing (BOB) Index
Change in interdental gingival bleeding between baseline (T0) and final follow-up (T5), assessed using the Bleeding on Interdental Brushing (BOB) Index. Results are expressed as the percentage of evaluated interdental sites presenting bleeding following interdental brushing.
Time frame: Baseline (T0) and final follow-up (T5), approximately 10 months
Longitudinal Changes in BOB Score
BOB Scores, expressed as percentages, measured across study visits to describe the trajectory of interdental gingival bleeding during implementation of the structured preventive care workflow.
Time frame: Baseline (T0) through final follow-up (T5), approximately 10 months
Change in Full Mouth Bleeding Score (FMBS)
Change in the percentage of periodontal sites presenting bleeding on probing, assessed using the Full Mouth Bleeding Score (FMBS).
Time frame: Baseline (T0) and final follow-up (T5), approximately 10 months
Change in Full Mouth Plaque Score (FMPS)
Change in the percentage of tooth surfaces presenting plaque, assessed using the Full Mouth Plaque Score (FMPS).
Time frame: Baseline (T0) and final follow-up (T5), approximately 10 months
Change in Periodontal Pocket Depth (PPD)
Change in periodontal probing depth, measured in millimetres using periodontal charting.
Time frame: Baseline (T0) and final follow-up (T5), approximately 10 months
Change in Gingival Margin Level
Change in gingival margin position, measured in millimetres relative to the cementoenamel junction.
Time frame: Baseline (T0) and final follow-up (T5), approximately 10 months
Change in Oral Health Motivation Scale (OHMS) Scores
Change in questionnaire scores assessing oral health motivation and related behaviours.
Time frame: Baseline (T0) and final follow-up (T5), approximately 10 months
Change in Health Belief Model (HBM) Questionnaire Scores
Change in questionnaire scores assessing health beliefs and perceptions related to oral health and preventive behaviours.
Time frame: Baseline (T0) and final follow-up (T5), approximately 10 months
Self-Reported Adherence to Interdental Cleaning
Participant-reported adherence to recommended interdental cleaning practices during follow-up.
Time frame: During the study, from T0 through T5, approximately 10 months
Change in Perceived Oral Health and Well-Being (POHW) Scores
Change in patient-reported perceived oral health and well-being questionnaire scores.
Time frame: Baseline (T0) and final follow-up (T5), approximately 10 months
Patient Satisfaction With the Preventive Care Workflow
Patient satisfaction questionnaire scores describing participants' experiences with the structured preventive care workflow.
Time frame: During the study, up to T5, approximately 10 months
Researcher Evaluation of Workflow Implementation
Researcher evaluation scores describing the implementation and practical application of the structured preventive care workflow.
Time frame: During the study, through T5, approximately 10 months
Workflow Usability Indicators
Descriptive indicators of the perceived usability and practical integration of the structured workflow in routine clinical care.
Time frame: During the study, through T5, approximately 10 months
Adherence to Protocol Steps
Descriptive measures of adherence to predefined study procedures and workflow steps across participating centres.
Time frame: Across study visits from T0 through T5, approximately 10 months.
Plan to share: Yes — De-identified individual participant data underlying the results reported in scientific publications may be made available to qualified researchers upon reasonable request, together with the relevant data dictionary. Access will be subject to scientific review, sponsor approval, applicable data protection requirements, and a data-sharing agreement. No directly identifying participant information will be shared.
Supporting information: Study protocol, Statistical analysis plan
Time frame: De-identified individual participant data and supporting documentation will be available upon reasonable request following publication of the main study results, subject to sponsor approval and applicable data protection requirements. Data will be retained and made available for the period permitted by the study's approved data management and retention arrangements.
Access criteria: Qualified researchers may request access to de-identified individual participant data underlying the published results for scientifically justified research purposes. Requests will be reviewed by the study sponsor, Curaden AG, in consultation with the Principal Investigator. Access will be subject to approval of the research proposal, compliance with applicable ethical and data protection requirements, and execution of an appropriate data-sharing agreement. Direct participant identifiers will not be provided.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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