CompletedPhase 2

Experimental Dentifrice Remineralization/Fluoride Uptake in an in Situ Model

20 participantsStarted 2007-09

Plain-language summary

The purpose of this study is to determine whether an experimental fluoridated dentifrice is effective in the treatment of dental caries

Age range18 Years – 78 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age: Aged between 18 and 78
✓. Fluoride: Currently living in the Indianapolis area which has a fluoridated water supply (1 ppm F) and not taking fluoride supplements for medical reasons
✓. Dentures: Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accommodate two enamel specimens (required dimensions 12 x 7 mm). Willing and capable of wearing their removable partial dentures 24 hours per day during the experimental periods
✓. Dental health:Have no current active caries or periodontal disease that may compromise the study or the health of the participants and all restorations in a good state of repair
✓. Salivary flow:Have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate ≥ 0.2 mL/min; gum base stimulated whole saliva flow rate ≥ 0.8 mL/min
✓. Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions
✓. Consent:Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
✓. General Health: Good general health with (in the opinion of the investigator) no clinically significant and/or relevant abnormalities of medical history or oral examination that could interfere with participant safety during the study period

✕. Antibiotics:Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit
✕. Allergy/Intolerance:Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
✕. Pregnancy:Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
✕. Breast-feeding:Women who are breast-feeding.
✕. Clinical Study/Experimental Medication: Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit
✕. Personnel:An employee of the sponsor or the study site who is directly involved in the study

Percentage Surface Micro-hardness Recovery (SMHR) of Enamel Specimens

Timeframe: Baseline to 14 days

NCT IDNCT00752089

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-01

Results submitted2011-09-07

Who can participate

Age range18 Years – 78 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age: Aged between 18 and 78
✓. Fluoride: Currently living in the Indianapolis area which has a fluoridated water supply (1 ppm F) and not taking fluoride supplements for medical reasons
✓. Dentures: Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accommodate two enamel specimens (required dimensions 12 x 7 mm). Willing and capable of wearing their removable partial dentures 24 hours per day during the experimental periods
✓. Dental health:Have no current active caries or periodontal disease that may compromise the study or the health of the participants and all restorations in a good state of repair
✓. Salivary flow:Have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate ≥ 0.2 mL/min; gum base stimulated whole saliva flow rate ≥ 0.8 mL/min
✓. Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions
✓. Consent:Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
✓. General Health: Good general health with (in the opinion of the investigator) no clinically significant and/or relevant abnormalities of medical history or oral examination that could interfere with participant safety during the study period

✕. Antibiotics:Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit
✕. Allergy/Intolerance:Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
✕. Pregnancy:Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
✕. Breast-feeding:Women who are breast-feeding.
✕. Clinical Study/Experimental Medication: Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit
✕. Personnel:An employee of the sponsor or the study site who is directly involved in the study