Effect of blend-a-med EXPERT GUMS PROTECTION with Stabilized Stannous Fluoride and Sodium Hexametaphosphate versus Lacalut Aktiv on Plaque prevention and removal via Digital Plaque Imaging Analysis

Bellamy P, Khera N, Day T, Barker M, Mussett A.

Digital Plaque Imaging Analysis (DPIA) was used to quantify in-vivo plaque formation during use of blend-a-med EXPERT GUMS PROTECTION containing Stannous Fluoride (SnF2) and Sodium Hexametaphosphate (SHMP) compared to Lacalut Aktiv.

Conclusions

• blend-a-med EXPERT GUMS PROTECTION reduces overnight plaque formation by a significantly greater degree than Lacalut Aktiv. Plaque coverage was an average of 19.4% lower (p=0.0043) after brushing with blend-a-med EXPERT GUMS PROTECTION than Lacalut Aktiv, the night before.

• Immediately after brushing with blend-a-med EXPERT GUMS PROTECTION, subjects have 25.6% less plaque coverage compared to Lacalut Aktiv. Again, this difference was statistically significant (p=0.0014).

• Given the important causative role plaque plays in development of gum problems, the benefit shown by blend-a-med EXPERT GUMS PROTECTION in this study reinforces the extensive literature reports of gum health benefits of SnF2/SHMP technologies when combined in toothpaste.

Objective

To evaluate how well two toothpaste formulations inhibited the growth of plaque in-vivo, when used under twice daily brushing conditions.

Materials and Methods

• 29 healthy adults were recruited for this double blind, randomized crossover study

• The dentifrices evaluated were:

blend-a-med EXPERT GUMS PROTECTION (SnF2/SHMP), containing Stannous Fluoride (1100 ppm),Sodium Hexametaphosphate and Sodium fluoride (350 ppm)

Lacalut Aktiv (Al-Chx), a commercially available dentifrice containing Aluminium Fluoride (1400ppm F), Chlorhexidine Digluconate (0.05%) and Aluminium Lactate (0.8%).

• Subjects used each test dentifrice along with a standard manual fl at profi le toothbrush (Oral B P35 Indicator, medium hardness) for a total of 17 days.

• The DPIA plaque assessment method was used (Sagel P, White D, Kozak M). Pre-brushing (early morning) plaque coverage of the teeth was evaluated on days 15, 16 and 17 (to investigate overnight plaque formation). Plaque coverage was also assessed on the same days immediately after brushing with the test product (40 seconds, self timed) and mid-afternoon (to evaluate plaque removal and daytime plaque formation respectively).

• On the evenings prior to assessment (days 14, 15 and 16) subjects brushed only their lingual aspect and were instructed to swish the toothpaste slurry around the whole mouth.

• Following the 17 day treatment, the subjects used the standard NaF paste for 4 days (wash-out phase) before moving onto the next test product. Subjects were instructed not to use any other oral hygiene procedures for the duration of the 10 week trial but were otherwise free to follow normal habits (diet, lifestyle, etc).

Statistics:

For each subject, visit, day, and treatment period, the percent plaque coverage was calculated from the digital images. Percent plaque coverage was averaged amongst the days to provide a single mean score for each subject, visit, and treatment period. For each visit (pre-brush, post-brush, and PM), mean percent plaque coverage was analyzed separately using analysis of variance (ANOVA) for crossover studies. The ANOVA model included subject, period, and treatment. The carryover effect was tested and found to be not statistically significant and was therefore removed from the model. Statistical comparisons were two-sided with a 5%significance level.

Results

• 27 subjects completed the study. 2 subjects were excluded due to elective dental treatment during the in-life study phase.

• The average amount of tooth area covered with plaque before brushing on mornings when subjects were using SnF2/SHMP dentifrice was 19.4% lower than when subjects were using Al-Chx toothpaste (13.1% of tooth surface covered with plaque, compared to 16.2%). This difference was statistically significant (p=0.0043).

• After brushing with SnF2/SHMP dentifrice, subjects had on average 25.6% less plaque (5.3% vs. 7.1%) compared to Al-Chx. This difference was statistically significant (p=0.0014) and probably in part due to the overnight plaque inhibition.

• When measured mid-afternoon, the average amount of the tooth covered with plaque was 19.8% lower when subjects had brushed with SnF2/SHMP in the morning, compared to Al-Chx (9.8% vs 12.2%). This difference was statistically significant (p=0.0057).

PERCENTAGE OF TOOTH COVERED WITH PLAQUE

% tooth area covered with plaque

Pre brushing Post brushing PM plaque

EXAMPLE PRE BRUSHING AND POST BRUSHING USING THE DPIA TECHNIQUE

Pre-brushing Post-brushing

Clinical comment

Reduction in plaque levels is regarded as one of the critical aspects for the prevention of gingivitis, and therefore helping to prevent any further progression of gingivitis into periodontitis. Good plaque control via brushing and chemical inhibition is an important part in any daily oral hygiene regimen. This study has shown that blend-a-med EXPERT GUMS PROTECTION is statistically significantly better in this regard vs. Lacalut Aktiv. Given that Lacalut Aktiv contains Chlorhexidine Digluconate this may appear surprising. However, there are extensive literature reports of the antimicrobial effectiveness of Chlorhexidine being reduced, or completely nullified when formulated into toothpastes containing the surfactant SLS (e.g. see numerous article by Addy M.).

---