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Implementation of dental monitoring to support home oral hygiene in adolescents undergoing fixed orthodontic treatment and adults undergoing systematic periodontal treatment – a clinical study

Implementation of dental monitoring to support home oral hygiene in adolescents undergoing fixed orthodontic treatment and adults undergoing systematic periodontal treatment – a clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00038275
Enrollment
160
Registered
2025-11-05
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K05.3

Interventions

Group 1: Dental monitoring with home visualisation of plaque using plaque disclosing tablets and personalised advice on home oral hygiene Group 2: Dental monitoring without home visualisation of plaqu

Sponsors

Universitätsklinikum Heidelberg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria (orthodontic cohort) • Patients with oral hygiene in need of improvement (plaque control record, PCR > 50%) • Patients aged 12 to 17 years • Patients receiving fixed orthodontic treatment with multibracket appliances or aligners • Ability of the subject/legal guardian to understand the nature and individual consequences of the clinical study • Written consent (from the legal guardian) after receiving information Inclusion criteria (periodontitis cohort) • Patients with oral hygiene in need of improvement (Plaque Control Record, PCR > 50%) • Patients aged 30 years and older • Patients with periodontitis, stage II-IV, grade A and B • Ability of the subject to understand the nature and individual consequences of the clinical study • Written informed consent

Exclusion criteria

Exclusion criteria: • Patients with a serious general illness • Patients who do not have a smartphone • Young people whose native language is not German • Objection by legal guardians in the case of underage study participants (orthodontic cohort)

Design outcomes

Primary

MeasureTime frame
Quantification of changes in plaque accumulation using the Quigley-Hein Index (QHI)

Secondary

MeasureTime frame
All study participants: - Clinical inflammation of the gums and laboratory-based monitoring of inflammation - Composition of the oral microbiome (supra-/subgingival biofilm samples and saliva) - Assessment of plaque detection using AI-supported detection methods in dental monitoring and comparison with the gold standard (clinical examination) - Subjectively perceived benefits of digital oral hygiene monitoring (questionnaire) - Comparability of Smart STL files generated by Dental Monitoring with STL files created by intraoral scanners Orthodontic cohort (adolescent patients): - Influence of orthodontic appliances on changes in oral hygiene and changes in gingival and periodontal inflammation parameters - Monitoring of gingival progression after three-dimensional tooth movements as part of orthodontic therapy Paro cohort (adult patients): - Changes in gingival and periodontal inflammation parameters - Influence of the age of the test subjects on changes in oral hygiene - Monitoring of gingival progression after periodontitis therapy

Countries

Germany

Contacts

Public ContactMarie-Therese Heberer

Universitätsklinikum Heidelber

Marie-Therese.Heberer@med.uni-heidelberg.de+49 6221 56 6581

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026