Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
1100 ppm F as fluoride · 1 trial · 1 indication
The SMH test was used to assess changes in the mineral status of partially demineralized enamel specimens. %SMH Recovery = (D1-R)/(D1-B) ×100 B = indentation length (µm) of sound enamel specimen at baseline D1 = indentation length (µm) after in vitro demineralization R = indentation length (µm) after intra-oral exposure.
| Arm | Type | Description |
|---|---|---|
| Test-Positive-Placebo | OTHER | Crossover design - Cleaning, 2-3 day non-Fluoride (F) dentifrice, Period 1 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 2 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 3 product for 2 weeks. Product sequence: 1100 ppm F as sodium fluoride Test Product,1100 ppm F as sodium fluoride (positive control) , 0 ppm F (placebo, negative control) |
| Test-Placebo-Positive | OTHER | Crossover design - Cleaning, 2-3 day non-F dentifrice, Period 1 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 2 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 3 product for 2 weeks. Product sequence: 1100 ppm F as sodium fluoride Test Product, 0 ppm F (placebo, negative control),1100 ppm F as sodium fluoride (positive control) |
| Positive-Test-Placebo | OTHER | Crossover design - Cleaning, 2-3 day non-F dentifrice, Period 1 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 2 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 3 product for 2 weeks. Product sequence: 1100 ppm F as sodium fluoride (positive control), 1100 ppm F as sodium fluoride Test Product, 0 ppm F (placebo, negative control) |
| Positive-Placebo-Test | OTHER | Crossover design - Cleaning, 2-3 day non-F dentifrice, Period 1 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 2 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 3 product for 2 weeks. Product sequence: 1100 ppm F as sodium fluoride (positive control), 0 ppm F (placebo, negative control), 1100 ppm F as sodium fluoride Test Product |
| Placebo-Test-Positive | OTHER | Crossover design - Cleaning, 2-3 day non-F dentifrice, Period 1 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 2 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 3 product for 2 weeks. Product sequence: 0 ppm F (placebo, negative control), 1100 ppm F as sodium fluoride Test Product,1100 ppm F as sodium fluoride (positive control) |
| Placebo-Positive-Test | OTHER | Crossover design - Cleaning, 2-3 day non-F dentifrice, Period 1 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 2 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 3 product for 2 weeks. Product sequence: 0 ppm F (placebo, negative control),1100 ppm F as sodium fluoride (positive control), 1100 ppm F as sodium fluoride Test Product |
| Name | Type | Description |
|---|---|---|
| 0 ppm F (placebo, negative control) | DRUG | • Each subject will use this product during one of the three treatment periods in the crossover study design. |
| 1100 ppm F as sodium fluoride (positive control) | DRUG | • Each subject will use this product during one of the three treatment periods in the crossover study design. |
| 1100 ppm F as sodium fluoride Test Product | DRUG | • Each subject will use this product during one of the three treatment periods in the crossover study design. |
Inclusion Criteria: 1. provide voluntary, written informed consent; 2. be between 18 and 85 years old; 3. understand and be willing, able and likely to comply with all study procedures and restrictions; 4. be wearing a removable mandibular partial denture with sufficient room to accommodate two 4 m...
1100 ppm F as fluoride is a small molecule fluoride dentifrice being studied for caries, or tooth decay. It is designed to remineralize tooth enamel and is being evaluated in a clinical trial involving healthy volunteers aged 18 years and older.
1100 ppm F as fluoride is being developed by Haleon plc, a consumer healthcare company traded on the London Stock Exchange under the ticker HLN. The company is conducting clinical research on this fluoride dentifrice for caries prevention.
1100 ppm F as fluoride is in Phase 3 clinical development. It is an investigational product and has not been approved by regulatory authorities. The Phase 3 trial has been completed, with results not yet publicly reported.
1100 ppm F as fluoride has one completed Phase 3 trial, NCT06010732, titled "In Situ Comparison of the Remineralization Potential of Optimized Fluoride Dentifrice With Control Fluoride Dentifrice." The randomized, double-blind, controlled study enrolled 52 participants in the United States.
1100 ppm F as fluoride works by delivering fluoride ions to tooth enamel, which promotes remineralization of early caries lesions. The fluoride helps rebuild weakened enamel and can reverse early signs of tooth decay, making the teeth more resistant to acid attacks.