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The additional use of a mouth wash with hydroxyapatite for the prevention of gingival diseases.

The additional use of a mouth wash with hydroxyapatite for the prevention of gingival diseases. - HAP-mouth wash for prevention of gingival diseases.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00031913
Enrollment
70
Registered
2023-08-29
Start date
2023-06-07
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

K05.1

Interventions

Group 1: Hydroxylapatite- mouthwash (Bioniq Repair® Zahn-Milch, DR. KURT WOLFF GMBH & CO KG, Bielefeld) The aim of this clinical study is to evaluate the preventive effect of a hydroxyapatite-contain

Sponsors

Universitätsmedizin Mainz, Poliklinik für Parodontologie und Zahnerhaltung
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Gingivitis, at least 10 teeth present without restoration, at least 4 toothed sextants with PSI code 1 or 2 (PSI code 0 may be occur with more than 4 toothed sextants), API = 25% on the corresponding sextants, non-smoker or light smoker (<10 cigs/day).

Exclusion criteria

Exclusion criteria: PSI code 3, 4; heavy smokers (= 10 cig. /day), pregnancy / hormone therapy / breastfeeding, taking antibiotics or anti-inflammatory drugs within the last 4 weeks before screening (taking antibiotics during the study will result in the study being discontinued); patients who need to take an antibiotic before dental treatment (e.g. endocarditis prophylaxis); allergies to ingredients of mouth washes or polishing paste; taking blood thinners; systemic diseases with an influence on the periodontium (e.g. diabetes mellitus, rheumatoid arthritis); vulnerable patient groups (Alzheimer's, Parkinson's, etc.); Immunocompromised / oncological patients; active orthodontic therapy (exception: retainers); treated periodontitis; cognitive or motor deficits / oral hygiene (OH) limitation; removable dentures; lack of ability to consent or insufficient language skills to understand procedures and patient information.

Design outcomes

Primary

MeasureTime frame
Plaque Index (Plaque Control Record; PCR) according to O´Leary et al. (1972) after 6 months +/- 21 days

Secondary

MeasureTime frame
Plaque Index (Plaque Control Record; PCR) according to O´Leary et al. (1972) after 3 months +/- 21 days, Gingiva Index (GI) according to Löe und Silness (1963) after 3 months +/- 21 days and after 6 months +/- 21 days (182 ± 21 Tage) and also dentin-hypersensitivity of the teeth.

Countries

Germany

Contacts

Public ContactAnna Damanaki

Poliklinik für Parodontologie und Zahnerhaltung

anna.damanaki@unimedizin-mainz.de49+6131 177247

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026