The caries-protective effect of the peptide P11-4 in home prevention during fixed multi-bracket treatment – a clinical randomized prospective study

Not Applicable

Recruiting

• Conditions: K02.0; Caries limited to enamel

• Registration Number: DRKS00028048
• Lead Sponsor: Philipps-Universität Marburg, FB Medizin, MZ für ZMKAbt. für Kieferorthopädie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Patients with a planned multibracket appliance (MB),
- Written, signed declaration of consent from the patient and the legal guardian before the start of the study,
- Individuals who are willing and able to attend all scheduled appointments,
- Patients willing and able to understand all study-related procedures and follow home-care instructions.

Exclusion Criteria

- Individuals with removable dentures,
- Individuals with recent dental trauma or dental surgery,
- Patients with a current periodontal disease,
- patients with bronchial asthma,
- Signs of tooth erosion (excessive drinking of acidic drinks, reflux),
- Medical conditions or concomitant medication that affect salivation or cause dry mouth,
- Last antibiotic intake < 2 months,
- Use of products that can cause tooth discoloration (e.g. chlorhexidine digluconate),
- Patients with known allergies/hypersensitivity to the used materials,
- Pregnant or breastfeeding women.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of demineralizations (?F in %) in the defined period of 18 months after baseline, measured using quantitative light-induced fluorescence (QLF).

Secondary Outcome Measures

Name	Time	Method
Change in (?F in %) over time: measurements every three months from baseline to study endpoint (18 months)