Dental plaque and one of the following endpoints: - enamel decalcification/white spot lesions - remineralized caries at the fissures and accessory cusps - caries - tartar - fluorosis Oral Health
Conditions
Interventions
At the screening, a dental plaque assessment is performed by a dental professional followed by the exams of enamel decalcification/white spot lesions, remineralization of caries at the fissures and ac
Sponsors
Procter & Gamble (United States)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Give written informed consent (if underage including her/his guardians) and given a signed copy of the Informed Consent form; 2. Be at least 13 years of age; 3. Have no fixed orthodontic appliance or attachments on both arches, Retainer in both arches are allowed; 4. Provide written informed consent prior to participation and be given a signed copy of the informed consent form; 5. Have plaque and at least one more of the following: demineralization/white spot lesions, remineralized caries at the fissures and accessory cusps, caries, tartar, fluorosis; 6. Possess a minimum of 24 natural and crowned/bridges evaluable teeth including 8 frontal teeth; 7. Be in good general health as determined by the Investigator/designee based on a review of the medical history/update for participation in the study; 8. Agree not to participate in any other clinical study for the duration of this study; 9. Agree to delay any elective dentistry, including dental prophylaxis, until study completion; 10. Agree to return for the scheduled clinical visit and follow study procedures.
Exclusion criteria
Exclusion criteria: 1. Severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession; 2. Active treatment for periodontitis; 3. Use of antibiotics two weeks prior to study initiation; 4. Any diseases or conditions that could be expected to interfere with the subject safely completing the study. 5. Presence of cardiac pacemaker; 6. Dental prophylaxis within 2 weeks prior to the screening visit. 7. Fixed orthodontic appliance e.g. Multibrackets apparatus or attachments on at least one arch
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At a single time point: 1. Dental plaque (pre-brushing) measured by test device and examiner based dental plaque index. 2. Enamel decalcification/ white spots measured by Enamel Decalcification Index. 3. Oral Conditions (by tooth/surface presence of remineralization of caries at the fissures and accessory cusps, caries, tartar, fluorosis) measured by appropriate common indices. | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures. | — |
Countries
Germany
Outcome results
None listed