Plaque-Induced GingivitisNCT07882459
Individualized Management of Plaque-Related Gingival Inflammation in Routine Dental Practice
A study testing Structured Preventive Care Workflow (iMGi) in people with Plaque-Induced Gingivitis, run by Curaden AG at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Plaque-Induced Gingivitis
- What is being tested?
- Structured Preventive Care Workflow (iMGi)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Dec 2026to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18-45 years.
- Presence of plaque-induced gingivitis, defined as a full-mouth bleeding on probing (BoP) score greater than 30% at baseline.
- Ability to provide written informed consent.
Who cannot join
- Diagnosis of periodontitis, defined as interproximal clinical attachment loss (CAL) ≥1 mm at two or more non-adjacent teeth, or buccal/oral CAL ≥3 mm with probing depth >3 mm at two or more teeth, not attributable to non-periodontitis-related causes (Tonetti et al., 2018).
- Ongoing dental or orthodontic care.
- Fewer than 20 natural teeth, excluding third molars.
- Absence of the four premolar-molar pairs.
- Systemic or infectious diseases.
- Current use of medications known to influence gingival or oral mucosal conditions.
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- Use of mouthrinses within the previous 4 weeks.
- Current tobacco smoking, including cigarettes, heated tobacco products, and e-cigarettes/vaping.
- Former smokers who stopped smoking less than 12 months before enrolment.
- Pregnancy or breastfeeding (as a precautionary exclusion criterion).
- Cognitive or behavioural impairments potentially limiting the ability to participate fully in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
Dr. med. dent. S. Flisfisch
Basel, Canton of Basel-City, CH-4051
Sohar Flisfisch, Dentist, 612725043, info@dent-basel.ch
Sohar Flisfisch, Dentist: Dr. med. dent.
About this study
Official title: Implementation of a Structured Preventive Care Workflow for Plaque-Related Gingival Inflammation in Routine Practice: A Prospective Study.
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Plaque-Induced Gingivitis
- Being tested
- Structured Preventive Care Workflow (iMGi)
- Keywords
- Gingival Inflammation, Preventive Oral Healthcare, Individualized Oral Self-Care Training, Interdental Cleaning, BOB Index, iMGi, iTOP, behaviour change, Calibrated Interdental Brushes, Interdental Brush Calibration, Oral Self-Care Training, Patient Education, Preventive Dental Care, Workflow Implementation, Interdental Bleeding, Plaque-Induced Gingivitis
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Preventive Care Workflow (iMGi)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Structured Preventive Care Workflow (iMGi) | Experimental | 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. Receives: Behavioral: Structured Preventive Care Workflow (iMGi) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Across study visits from T0 through T5, approximately 10 months
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Across study visits from T0 through T5, approximately 10 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque-Induced GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, non-randomized, single-arm, multicentre implementation study conducted under routine clinical conditions. All participants receive preventive care according to the same structured iMGi workflow, with longitudinal assessments from baseline (T0) through the final follow-up (T5) over approximately 10 months. No comparator group is included.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Curaden AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07882459
- Sponsor's protocol ID
- 2026-00696
- Other IDs
- 2026-00696
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.