NCT07826715

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 17, 2026

Completed
Last Updated

September 17, 2026

Status Verified

September 1, 2026

Enrollment Period

3 months

First QC Date

September 14, 2026

Last Update Submit

September 14, 2026

Conditions

Keywords

Oral hygiene educationPersonalized three-dimensional visualizationDental plaqueGingival inflammationDental treatment motivationPatient education

Outcome Measures

Primary Outcomes (1)

  • Change in Full-Mouth Rustogi Modified Navy Plaque Index From Baseline to Week 6

    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.

    Baseline and 6 weeks

Secondary Outcomes (4)

  • Change in Full-Mouth Gingival Index From Baseline to Week 6

    Baseline and 6 weeks

  • Change in Full-Mouth Papillary Bleeding Index From Baseline to Week 6

    Baseline and 6 weeks

  • Intrinsic Motivation Assessed by the Dental Treatment Motivation Scale

    Baseline and 6 weeks

  • Extrinsic Motivation Assessed by the Dental Treatment Motivation Scale

    Baseline and 6 weeks

Study Arms (3)

Conventional Method (CM)

ACTIVE COMPARATOR

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.

Behavioral: Conventional Oral Hygiene Education

Three-Dimensional Animation (3DA)

ACTIVE COMPARATOR

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.

Behavioral: Three-Dimensional Animation-Based Oral Hygiene Education

Periodontal Disease Prediction (PDP)

ACTIVE COMPARATOR

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.

Behavioral: Personalized Three-Dimensional Visualization With Motivational Discussion

Interventions

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.

Conventional Method (CM)

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.

Three-Dimensional Animation (3DA)

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.

Periodontal Disease Prediction (PDP)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Bolu Abant İzzet Baysal University, Department of Periodontics

Bolu, Central, 14100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

GingivitisDental Plaque

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesDental DepositsTooth Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist Prof

Study Record Dates

First Submitted

September 14, 2026

First Posted

September 17, 2026

Study Start

August 15, 2021

Primary Completion

November 15, 2021

Study Completion

December 15, 2021

Last Updated

September 17, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations