A study to assess the ability to detect dental plaque by a new device using fluorescence based technology.

Not Applicable

• Conditions: 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

• Registration Number: ISRCTN84038664
• Lead Sponsor: Procter & Gamble (United States)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-05
• Last Update Posted: 5 August 2022
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 50

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
At a single time point:<br>1. Dental plaque (pre-brushing) measured by test device and examiner based dental plaque index. <br>2. Enamel decalcification/ white spots measured by Enamel Decalcification Index.<br>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 Outcome Measures

Name	Time	Method
There are no secondary outcome measures.