A Prospective, randomized, clinical study on the effects of CPP-ACP paste on plaque, gingivitis and initial caries lesion development in orthodontic patients - part 2

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-002982-30-BE

Enrollment

400

Registered

2008-09-08

Start date

2008-10-09

Completion date

Unknown

Last updated

2023-12-19

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

Conditions

Plaque and the initial development of caries and gingivitis in orthodontic patients.

Interventions

Trade Name: Elmex Medical Gel Product Name: Elmex Medical Gel Pharmaceutical Form: Gel CAS Number: 16984488 Other descriptive name: Fluoride Concentration unit: % percent Concentration type: equal Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Teeth whom white spots are absent and whom buccal surfaces are entirely visible. Patients who sign the informed consent. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Teeth whom white spots are already present and whom buccal surfaces are not entirely visible because not fully erupted or deep bite. Patients who won’t sign the informed consent.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effects of a high concentration fluoride toothpaste, GC Tooth Mousse and GC MI Paste Plus on plaque and on the initial development of caries and gingivitis in orthodontic patients. Questions: Is there a significant difference in preventive effect between Elmex Medical Gel, GC Tooth Mouse and GC MI Paste Plus? ;Secondary Objective: ;Primary end point(s): White Spot Lesion Plaque Gingival Bleeding	—

Measure

Time frame

Main Objective: To investigate the effects of a high concentration fluoride toothpaste, GC Tooth Mousse and GC MI Paste Plus on plaque and on the initial development of caries and gingivitis in orthodontic patients. Questions: Is there a significant difference in preventive effect between Elmex Medical Gel, GC Tooth Mouse and GC MI Paste Plus? ;Secondary Objective: ;Primary end point(s): White Spot Lesion Plaque Gingival Bleeding

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Countries

Belgium

Outcome results

None listed

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