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Study investigating oral hygiene status and quality of life of patients before, during, and after fixed orthodontic treatment

Study investigating oral hygiene status and quality of life of patients before, during, and after fixed orthodontic treatment

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
DRKS
Registry ID
DRKS00039415
Enrollment
150
Registered
2026-02-23
Start date
2013-08-05
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

oral health

Interventions

Group 1: Patients with fixed orthodontic appliances (multibracket appliances) undergo clinical examinations on nine time points (from before the appliance is applied to one year after it's removement)

Sponsors

Universitätsklinikum Mainz
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 18 Years

Inclusion criteria

Inclusion criteria: To be included in the study, each subject must: - have a malocclusion/dysgnathia and a treatment plan approved multibracket appliance in the upper and lower jaw - be between 12 and 18 years of age - have no previous fixed orthodontic multibracket appliance in the upper or lower jaw - be provided with and sign a written consent form and subject information sheet prior to participation - have a minimum of 16 natural teeth, including 8 front teeth - be in good general health, as determined by the examiner based on a current medical history - Agree not to participate in any other clinical studies for the duration of this study - Agree not to have any additional professional teeth cleanings performed externally - Maintain their previous manual or electric brushing habits - Agree to return for the scheduled clinical visits and follow the study protocol

Exclusion criteria

Exclusion criteria: Subjects will be excluded from participation in the study if: - orthodontic treatment is not necessary - severe periodontal disease, characterized by purulent exudates, tooth mobility, and/or gingival recession, is present - they have allergies to dyes/coloring agents used in cosmetic products and foodstuffs - transparent brackets are used - periodontal treatment is being carried out - more than 3 carious defects need to be treated - antibiotics were taken two weeks before the start of the study - they wear a pacemaker - Pregnancy (as determined by questioning the patient) - Professional teeth cleaning was performed 2 weeks prior to screening - Unreliability and lack of cooperation - Other objections to study participation in the opinion of the treating dentist - Known syndromes and general illnesses

Design outcomes

Primary

MeasureTime frame
- Oral hygiene parameters (baseline - visit 9) through clinical examination

Secondary

MeasureTime frame
- Periodontal marker bacteria - Light-induced fluorescence measurement (QLF) - Questionnaire on oral health-related quality of life (PIDAQ) - Complexity, outcome, and necessity index (ICON index)

Countries

Germany

Contacts

Public ContactChristina Erbe

Universitätsklinikum Mainz, Poliklinik für Kieferorthopädie

erbe@uni-mainz.de+493030

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026