- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07826715
Personalized 3D Visualization for Oral Hygiene and Motivation in Adults With Gingivitis
This study evaluated whether personalized three-dimensional images of possible future changes in the gums could improve oral hygiene and motivation in adults with gingivitis. Gingivitis is inflammation of the gums associated with dental plaque.
Eighty-four adults aged 18-60 years were randomly assigned to three groups of 28 participants. The groups received conventional oral hygiene education, general three-dimensional educational animations, or personalized three-dimensional visualization using models created from their own intraoral scans. All participants received the same nonsurgical periodontal treatment and instruction in toothbrushing and cleaning between the teeth.
The personalized images illustrated possible gum recession and tissue changes if periodontal care and daily plaque control were neglected. They were educational scenarios, not individual predictions of future disease. Personalized visualization was accompanied by a clinician-guided motivational discussion.
Dental plaque, gum inflammation, gum bleeding, and motivation toward dental treatment were assessed before treatment and six weeks later. The study compared these outcomes among the three educational approaches.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Central
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Bolu, Central, Turkey (Türkiye), 14100
- Faculty of Dentistry, Bolu Abant İzzet Baysal University, Department of Periodontics
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 18-60 years. Systemically healthy. Diagnosis of gingivitis according to the 2017 World Workshop classification. At least 20 natural teeth, excluding third molars. At least 12 years of formal education. Turkish as the native language. Probing depths ≤3 mm. Bleeding on probing at more than 10% of sites. Visible plaque at more than 50% of sites. Provision of written informed consent.
Exclusion Criteria:
- Dentists or dental students. Previous periodontal treatment or structured oral hygiene education. Use of antibiotics or nonsteroidal anti-inflammatory drugs within the preceding 3 months.
Generalized gingival recession or dentin hypersensitivity. Full-arch fixed or removable prostheses. Acute odontogenic infections. Overhanging or defective restorations, or root caries that could affect oral hygiene practices.
Active orthodontic treatment. Communicable diseases such as hepatitis or HIV infection. Cognitive, systemic, or physical conditions that could interfere with understanding the educational content or performing oral hygiene practices.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Conventional Method (CM)
Participants received nonsurgical periodontal treatment and conventional face-to-face oral hygiene education supported by practical demonstrations using a dental model and a written information leaflet.
Education covered periodontal disease, dental plaque, and daily oral hygiene practices, including the modified Bass toothbrushing technique and appropriate interdental cleaning.
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Face-to-face education delivered by a clinician using a dental model and a written information leaflet.
The content covered the causes of periodontal diseases, the role of dental plaque, and daily oral hygiene practices.
Participants received instruction in the modified Bass toothbrushing technique and appropriate interdental cleaning.
|
|
Active Comparator: Three-Dimensional Animation (3DA)
Participants received nonsurgical periodontal treatment and clinician-guided oral hygiene education using DentalMaster three-dimensional educational software.
The educational content covered the causes and clinical signs of periodontal diseases, periodontal treatment, and daily oral care.
General three-dimensional animations illustrated potential gingival recession, periodontal tissue loss, and tooth loss associated with inadequate plaque control.
Participants were instructed in the modified Bass toothbrushing technique and appropriate interdental cleaning.
|
Clinician-guided oral hygiene education using DentalMaster three-dimensional educational software.
The content covered the causes and clinical signs of periodontal diseases, periodontal treatment, and daily oral care.
General three-dimensional animations illustrated potential gingival recession, periodontal tissue loss, and tooth loss associated with inadequate plaque control.
Participants received instruction in the modified Bass toothbrushing technique and appropriate interdental cleaning.
|
|
Active Comparator: Periodontal Disease Prediction (PDP)
Participants received nonsurgical periodontal treatment and clinician-guided education on periodontal disease and daily oral care.
Personalized three-dimensional dentogingival models generated from their intraoral scans using the Periodontal Disease Prediction (PDP) system illustrated potential gingival recession and visible tissue changes if periodontal care and plaque control were neglected.
Images were presented as conditional educational scenarios, not individualized prognostic predictions.
Visualization was accompanied by a motivational discussion addressing personal goals and barriers to oral hygiene.
Participants were instructed in the modified Bass toothbrushing technique and appropriate interdental cleaning.
|
Participants viewed general educational animations about periodontal disease, treatment, and daily oral care, followed by personalized three-dimensional dentogingival models generated from their own intraoral scans using the Periodontal Disease Prediction (PDP) system.
The models illustrated potential gingival recession and visible periodontal tissue changes if periodontal care and daily plaque control were neglected.
These images were presented as conditional educational scenarios, not individualized prognostic predictions.
A clinician-guided motivational discussion addressed personal goals and barriers to oral hygiene.
Participants also received instruction in the modified Bass toothbrushing technique and appropriate interdental cleaning.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Full-Mouth Rustogi Modified Navy Plaque Index From Baseline to Week 6
Time Frame: Baseline and 6 weeks
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Dental plaque was assessed using the Rustogi Modified Navy Plaque Index (RMNPI) after application of a plaque-disclosing agent.
The facial and lingual/palatal surfaces of each eligible tooth were divided into nine areas, scored as 0 for absence of plaque or 1 for presence of plaque.
The full-mouth score was calculated as the proportion of assessed areas with plaque, ranging from 0 to 1, with higher scores indicating more plaque.
Third molars and teeth with crowns or cervical restorations were excluded.
Change was calculated as the week 6 score minus the baseline score; negative values indicate improvement.
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Baseline and 6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Full-Mouth Gingival Index From Baseline to Week 6
Time Frame: Baseline and 6 weeks
|
Gingival inflammation was assessed using the Löe and Silness Gingival Index at four sites around each tooth.
Scores range from 0 to 3, with higher scores indicating more severe gingival inflammation.
A full-mouth mean score was calculated for each participant.
Change was calculated as the week 6 score minus the baseline score; negative values indicate improvement.
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Baseline and 6 weeks
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Change in Full-Mouth Papillary Bleeding Index From Baseline to Week 6
Time Frame: Baseline and 6 weeks
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Interdental gingival bleeding was assessed using the Papillary Bleeding Index (PBI).
Interdental papillae were scored from 0 to 4 according to the severity of bleeding elicited after probing, with higher scores indicating more severe bleeding.
A full-mouth mean score was calculated for each participant.
Change was calculated as the week 6 score minus the baseline score; negative values indicate improvement.
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Baseline and 6 weeks
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Intrinsic Motivation Assessed by the Dental Treatment Motivation Scale
Time Frame: Baseline and 6 weeks
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Intrinsic motivation was assessed using the seven-item intrinsic motivation subscale of the Dental Treatment Motivation Scale (DTMS).
Each item was rated on a five-point Likert scale from 1 (strongly disagree) to 5 (strongly agree).
The mean item score was calculated, ranging from 1 to 5, with higher scores indicating greater intrinsic motivation.
Scores were assessed at baseline and week 6 and compared among the three study groups.
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Baseline and 6 weeks
|
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Extrinsic Motivation Assessed by the Dental Treatment Motivation Scale
Time Frame: Baseline and 6 weeks
|
Extrinsic motivation was assessed using the eight-item extrinsic motivation subscale of the Dental Treatment Motivation Scale (DTMS).
Each item was rated on a five-point Likert scale from 1 (strongly disagree) to 5 (strongly agree).
The mean item score was calculated, ranging from 1 to 5, with higher scores indicating greater extrinsic motivation.
Scores were assessed at baseline and week 6 and compared among the three study groups.
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Baseline and 6 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BAİBU-Perio-ZA-05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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