Table 4 Regression Studies included in the Final Review

Bailey et al. [33] 2009

Regression of post-orthodontic lesions by a remineralizing cream

Optimal water fluoridation.

A double-blind randomized clinical trial to test whether more white spot lesions would regress in participants using Tooth Mousse® than a placebo paste. Patients applied Tooth Mousse® or placebo paste twice daily following toothbrushing for 12 weeks.

45 adolescents aged 12 to 19 years immediately following debonding of fixed orthodontic appliances.

ICDAS II clinical scoring

No statistically significant difference in the transition scores between the intervention and control groups was found overall. Regression of lesions with severity codes 2 or 3 at baseline in the Tooth Mousse® group were statistically significant higher than the placebo group at 12 weeks.

Both groups used fluoride toothpaste (1000 ppm) and supervised fluoride mouthrinses (900 ppm) given at each assessment visit to both groups.

Altenburger et al. [34] 2010

The evaluation of fluorescence changes after application of casein phophopeptides (CPP) and amorphous calcium phosphate on early carious lesions.

Unspecified water fluoridation.

A single-blind randomized clinical study to test the daily application of Tooth Mousse® to remineralize initially demineralized enamel fissures compared to a control group. Patients in test group applied Tooth Mousse® once daily onto the occlusal surface of teeth.

32 subjects aged 22 to 31 years with molars and premolars with DIAGNOdent readings between 15 and 20.

DIAGNOdent readings and visual classification according to Ekstrand et al. [42]

There was a statistically significant difference between the DIAGNOdent reading in the test and control groups after 2 and 3 weeks. No statistical difference was found between the groups using the visual classification.

Fluoride toothpaste (1450 ppm) used by both groups.

Beerens et al. [35] 2010

Effects of casein phophopeptide amorphous calcium fluoride phosphate paste of white spot lesions and dental plaque after orthodontic treatment: a 3-month follow-up.^b

Unfluoridated water.

A double-blind randomized clinical trial to investigate the effects of Tooth Mousse Plus® on dental plaque and on the remineralization of enamel white spot lesions compared to a control group.

65 adolescents 12–19 years of age immediately following the removal of fixed orthodontic appliances.

Quantitative light-induce fluorescence (QLF) images and plaque samples.^b

Significant improvement in lesion depth was observed in both groups. No significant difference was found between the test and control groups after 12 weeks.

Fluoride toothpaste (unspecified concentration) used by both groups.

Patients applied Tooth Mousse Plus® or placebo paste once daily before bedtime.

Brochner et al. [36] 2011

Treatment of post-orthodontic white spot lesions with casein phosphopeptide-stabilised amorphous calcium phosphate.

Low water fluoridation (<0.2 ppm).

A randomized single-blind clinical study to investigate the effect of daily applications of Tooth Mousse® on white spot lesions compared to a control group.

60 adolescents aged 13–18 years immediately following the removal of fixed orthodontic appliances.

Visual inspection of photographs and Quantitative light-induced fluorescence (QLF) measurements.

Statistically significant regression of white spot lesions measured by visual inspection and QLF was found in both the intervention and control groups. There was no significant difference between the groups after 4 weeks.

Fluoride toothpaste (1100 ppm) used once daily in the test group and twice daily in the control group.

Patients in the test group applied Tooth Mousse® once daily in the evening and brushed with fluoride toothpaste in the morning. Patients in the control group brushed twice daily with fluoride toothpaste.

Wang et al. [37] 2012

Clinical evaluation of remineralization potential of casein phosphopeptide amorphous calcium phosphate nanocomplexes for enamel decalcification in orthodontics.

Unspecified water fluoridation. Test group used non-fluoridated toothpaste. Control group used fluoride toothpaste (1100 ppm).

A single-blind clinical study to evaluate the remineralizing effect of Tooth Mousse® versus twice-daily brushing with fluoride toothpaste on enamel decalcification in orthodontics. Randomization of test and control group was not reported.

40 adolescents aged below 18 years of age undergoing fixed orthodontic appliance therapy.

Visual inspection of photographs scored using an enamel decalcification index (EDI).

Statistically significant reductions in the EDI of the Tooth Mousse® group were found. No statistically significant reduction of EDI was reported in the fluoride toothpaste group during the 6 month study.

Patients in the test group applied Tooth Mousse® once daily following evening toothbrushing with non-fluoride toothpaste. Patients in the control group brushed twice daily with fluoride toothpaste

Akin & Basciftci [38] 2012

Can white spot lesions be treated effectively?

Unspecified water fluoridation.

A prospective clinical controlled study to determine the effectiveness of 0.025 % (100 ppm) sodium fluoride mouthrinse, Tooth Mousse® and the microabrasion technique in reducing white spot lesions compared with a control group. Randomization of test and control groups and blinding was not reported. Patients in the Tooth Mousse® group applied the crème twice daily after toothbrushing with fluoride toothpaste. Patients in the mouthrinse group rinsed for 30 s twice daily after brushing with fluoride toothpaste. In the microabrasion group the procedure was performed with a 18 % hydrochloric acid/pumice mixture and was repeated four or five times. Patients in the control group brushed their teeth (toothpaste not specified).

80 adolescents with post-orthodontic demineralized lesions.

Digital photographic images.

Statistically significant reductions in the extent of white spot lesions occurred in all groups. Microabrasion, followed by Tooth Mousse® showed the highest success rates for the postorthodontic remineralization over a 6 month study period.

The Mouthrinse and Tooth Mousse Groups used fluoride toothpaste (unspecified concentration). The Control group brushed their teeth (toothpaste unspecified) and there was no reporting of toothbrushing in the Microabrasion group

Krithikadatta et al. [39] 2013

Remineralisation of occlusal white spot lesions with a combination of 10 % CPP-ACP and 0.2 % sodium fluoride evaluated using DIAGNOdent: A pilot study.

Unspecified water fluoridation. All groups had standardised diet and oral hygiene practices (use of fluoride toothpaste was unspecified).

A randomzed single-blind clinical study to evaluate the efficacy of Tooth Mousse®, Tooth Mousse Plus® compared to 0.5 % fluoride mouthrinse for the remineralisation of occlusal white spot lesions. Patients in the Tooth Mousse® and Tooth Mousse Plus® groups applied the respective crèmes twice daily following toothbrushing. Patients in the mouthrinse group rinsed once daily for 30 s.

45 dental students aged 17–20 years.

DIAGNOdent readings and visual classification according to Ekstrand et al. [42]

All 3 groups showed highly significant remineralising potential at 30 days. Tooth Mousse® and Tooth Mousse Plus® showed significantly higher remineralisation compared to the fluoride mouthrinse group.

Vashisht et al. [40] 2013

Role of casein phosphopeptide amorphous calcium phosphate in remineralization of white spot lesions and inhibition of Streptococcus mutans?^c

Unspecified water fluoridation. Both groups used fluoride toothpaste (1450 ppm).

A randomized clinical study to evaluate the remineralizing effect of Tooth Mousse® on white spot lesions compared with a control group. Blinding of the examiner was not reported. Patients in the Tooth Mousse® group applied the crème twice daily after toothbrushing. Patients in the control group brushed twice daily.

60 adolescents undergoing orthodontic treatment

DIAGNOdent readings and visual classification using ICDAS II clinical scoring

There was a statistically significant increase in DIAGNOdent readings in the control group from baseline after 3 months. There was no significant difference found in the DIAGNOdent readings in the test group from baseline to 3 months.

Huang et al. [41] 2013

Effectiveness of MI Paste Plus and PreviDent fluoride varnish for the treatment of white spot lesions: A randomized controlled trial.

Unspecified water fluoridation. All groups used fluoride toothpaste (1100 ppm).

A randomized single-blind parallel group trial comparing the effectiveness of daily application of MI Paste Plus® for 8 weeks with a single application of 5 % sodium fluoride varnish to a control group in improving the appearance of white spot lesions after orthodontic treatment.

115 adolescents aged between 12 and 20 years following orthodontic treatment.

Visual assessment using photographic records performed by dental experts, lay persons and the patients.

No significant differences were found in the test groups compared to the control group at the end of the 8 week study by any of the examining panels.

Patients in the MI Paste Plus® group applied the crème twice daily. Patients in the fluoride varnish group received a single application of varnish at the start of the study. Patients in the control group followed routine oral hygiene at home.