Resin Infiltration vs. CPP-ACP-Fluoride for White Spot Lesions

Overseen By Nancy Abdelhay, DMD, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Poor oral hygiene, Hypoplasia, Restorations, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

62 Participants Needed

Trial Summary

What is the purpose of this trial?

Dental cavities are among the most frequent diseases that affect teeth, particularly in patients who are treated with braces due to the difficulty in maintaining good oral hygiene in the presence of the mouth appliances. The white spot lesion (WSL) is the first clinical sign of cavities that presents itself as a milky-white opacity when located on the front face of the tooth. The aim to manage these early lesions focuses on promoting natural remineralization and preventing further demineralization. Various materials have been introduced for management of WSLs including MI paste and MI paste combined with fluoride (MI paste plus). Recently, a new material called resin infiltration has been found to treat these lesions with high esthetic results and great performance. According to the few numbers of in-vivo studies investigating the effectiveness of remineralization products, the aim of the current study is to clinically compare the outcome of the resin-infiltration and etching + MI paste plus to stop and improve the appearance of the WSL on front teeth in patients after treatment with braces.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have been using any re-mineralizing agents other than regular toothpaste in the last three months, you may not be eligible to participate.

What data supports the effectiveness of the treatment Casein Phosphopeptide (CPP) - Amorphous Calcium Phosphate (ACP) - Fluoride for white spot lesions?

Research shows that combining CPP-ACP with fluoride can be more effective in remineralizing white spot lesions than using fluoride alone, especially in short-term treatments. However, a study found no significant clinical advantage of using CPP-ACFP paste over normal oral hygiene in reducing white spot lesions after orthodontic treatment. ^{1 2 3 4 5}

Is CPP-ACP with fluoride safe for humans?

CPP-ACP, derived from milk protein, is generally considered safe for humans and has been used in various dental products to help prevent tooth decay and treat white spot lesions. It has been studied in laboratory, animal, and human settings without significant safety concerns. ^{1 6 7 8 9}

How does the treatment of Resin Infiltration and CPP-ACP-Fluoride for white spot lesions differ from other treatments?

This treatment is unique because it combines resin infiltration, which fills and seals the white spot lesions, with CPP-ACP and fluoride, which help to remineralize and strengthen the enamel. This dual approach not only improves the appearance of the lesions but also enhances the enamel's resistance to further decay. ^{1 4 10 11 12}

Research Team

Ida M Kornerup, DMD, MEd

Principal Investigator

University of Alberta

Eligibility Criteria

This trial is for young people aged 12-21 who've had braces for 1-3 years and have white spots on their front teeth after the braces come off. They should have decent oral hygiene but haven't used any special tooth treatments in the last three months, except regular toothpaste.

Inclusion Criteria

I am between 12-21 years old and had braces for 12-36 months.

You should have at least one white spot on the front teeth after braces are removed. The spot should be visible whether the teeth are dry or wet.

You have mild to moderate plaque buildup and not-so-good oral hygiene, with a simplified Oral Hygiene Index score between 1.3 and 3.0.

Exclusion Criteria

I haven't used any dental treatments besides regular toothpaste in the last 3 months.

I have a health, dental, or mental condition.

You have significant oral hygiene issues, rated 3.1 or higher on a scale from 0 to 6.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an 8-week regimen of MI paste plus or resin infiltration

8 weeks

Follow-up

Participants are monitored for changes in WSL appearance and remineralization at 3, 6, 12, and 18 months

18 months

4 visits (in-person)

Long-term follow-up

Continued monitoring of WSL changes and patient satisfaction over a 3-year period

3 years

Treatment Details

Interventions

• Casein Phosphopeptide (CPP) - Amorphous Calcium Phosphate (ACP) - Fluoride
• Resin infiltration

Trial Overview The study compares two ways to treat early signs of cavities that show up as white spots after wearing braces: a paste called MI Paste Plus and a new method called resin infiltration. The goal is to see which one works better at stopping and improving these spots.

Participant Groups

Group I: Resin Infiltration Active Control 2 Interventions

Resin infiltration of early intervention of caries lesion as a consequences of orthodontic treatment

Group II: Casein Phosphopeptide (CPP) - Amorphous Calcium Phosphate (ACP) - Fluoride Active Control 2 Interventions

Casein Phosphopeptide (CPP) - Amorphous Calcium Phosphate (ACP) - Fluoride early intervention of caries lesion as a consequences of orthodontic treatment

Casein Phosphopeptide (CPP) - Amorphous Calcium Phosphate (ACP) - Fluoride is already approved in European Union, United States for the following indications:

Approved in European Union as MI Paste Plus for:

• Relief of tooth sensitivity
• Prevention of dental caries
• Remineralization of enamel
• Treatment of white spot lesions

Approved in United States as MI Paste Plus for:

• Relief of tooth sensitivity
• Prevention of dental caries
• Remineralization of enamel
• Treatment of white spot lesions

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Findings from Research

The study found that a 1.1% NaF dentifrice (5000ppm fluoride) was more effective in remineralizing white spot lesions compared to a 10% CPP-ACP crème (MI Paste) and a CPP-ACP crème with 900ppm fluoride (MI Paste Plus) over a 30-day period.

While the NaF dentifrice showed superior remineralization effects initially, it was only as effective as the control in reducing fluorescence loss after 30 days, indicating that fluoride enhances remineralization but may not significantly change long-term outcomes compared to no treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remineralization effect of CPP-ACP and fluoride for white spot lesions in vitro. Oliveira, GM., Ritter, AV., Heymann, HO., et al.[2022]

A study using 28 bovine enamel slabs demonstrated that a combination of casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) and fluoride is more effective in preventing enamel demineralization compared to fluoride alone, especially with short processing times.

The enamel treated with the CPP-ACP and fluoride mixture showed no tissue loss, indicating that this combination helps maintain enamel integrity during remineralization processes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined effect of paste containing casein phosphopeptide-amorphous calcium phosphate and fluoride on enamel lesions: an in vitro pH-cycling study. Ogata, K., Warita, S., Shimazu, K., et al.[2022]

Minimally invasive treatments, including fluorides, CPP-ACP, and resin infiltration, significantly improved the appearance and reduced white spot lesions compared to placebo or control, based on a review of eight randomized controlled trials.

Three different fluoride preparations and resin infiltration were particularly effective, with significant results observed in studies using DIAGNOdent and ICDAS for assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimally Invasive Treatment of White Spot Lesions--A Systematic Review. Abdullah, Z., John, J.[2021]

In a study involving 54 orthodontic patients over 3 months, the use of casein phosphopeptide amorphous calcium fluoride phosphate (CPP-ACFP) paste did not show a significant advantage in remineralizing white spot caries lesions compared to a control paste.

Both groups experienced a decrease in harmful bacteria like Streptococcus mutans, but there was no significant difference in plaque composition or caries regression between the CPP-ACFP paste and control paste.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of casein phosphopeptide amorphous calcium fluoride phosphate paste on white spot lesions and dental plaque after orthodontic treatment: a 3-month follow-up. Beerens, MW., van der Veen, MH., van Beek, H., et al.[2022]

Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) paste shows strong potential for remineralizing white spot lesions, both naturally occurring and those resulting from orthodontic treatment, based on a systematic review of 12 randomized control trials.

The effectiveness of CPP-ACP paste is comparable to that of fluoride varnish and fluoridated toothpaste, indicating it could be a viable alternative for dental remineralization without significant differences in outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remineralizing potential of CPP-ACP in white spot lesions - A systematic review. Indrapriyadharshini, K., Madan Kumar, PD., Sharma, K., et al.[2022]

The study found that both CPP-ACP and CPP-ACP with fluoride (CPP-ACPF) pastes significantly reduced enamel demineralization compared to a control group, indicating their efficacy in protecting tooth enamel.

CPP-ACPF paste showed superior results in minimizing mineral loss and lesion depth after 72 and 120 hours of exposure to a demineralizing solution, suggesting that the addition of fluoride enhances the protective effects of casein phosphopeptides.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of CPP-ACP with sodium fluoride on inhibition of bovine enamel demineralization: a quantitative assessment using micro-computed tomography. Hamba, H., Nikaido, T., Inoue, G., et al.[2022]

Both CPP-ACPF and CPP-ACP pastes significantly increased the levels of calcium, phosphate, and fluoride in the saliva and dental plaque of 25 preschool children with Early Childhood Caries (ECC).

CPP-ACPF paste resulted in a higher concentration of fluoride in saliva compared to CPP-ACP, suggesting that CPP-ACPF may be more effective in preventing dental caries, especially in children with poor oral hygiene.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in the Concentration of Ions in Saliva and Dental Plaque after Application of CPP-ACP with and without Fluoride among 6-9 Year Old Children. Poureslami, H., Hoseinifar, R., Khazaeli, P., et al.[2020]

CPP-ACP, a bioactive agent derived from milk proteins, effectively stabilizes calcium phosphate in dental plaque, which helps reduce tooth demineralization and promotes remineralization, making it beneficial for dental health.

Research indicates that CPP-ACP can inhibit tooth decay, treat white spot lesions, and reduce tooth sensitivity, and it has potential applications in various dental products and even food items to help prevent cavities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of casein phosphopeptides-amorphous calcium phosphate. Reema, SD., Lahiri, PK., Roy, SS.[2022]

Pastes containing casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) and casein phosphopeptide-amorphous calcium fluoride phosphate (CPP-ACFP) effectively remineralized demineralized enamel surfaces, resulting in a smoother and more flattened enamel appearance compared to untreated enamel.

The study demonstrated that both CPP-ACP and CPP-ACFP treatments significantly improved enamel microhardness, indicating their potential as effective agents for enamel remineralization, while 0.05% NaF also reduced enamel defects but was less effective in occluding them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of pastes containing casein phosphopeptide-amorphous calcium phosphate on surface of demineralized enamel. Peric, TO., Markovic, DL., Radojevic, VJ., et al.[2022]

Resin infiltration (Icon) was found to be the most effective treatment for improving the appearance of white-spot lesions (WSLs), showing a significant color change (ΔE) and fluorescence recovery (ΔQ) compared to fluoride and casein phosphopeptide amorphous calcium phosphate (CPP-ACP) treatments.

While fluoride and CPP-ACP treatments did show some improvement, their effects were not significant until 4 weeks after treatment, indicating that resin infiltration provides quicker and more noticeable esthetic results for WSLs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Esthetic comparison of white-spot lesion treatment modalities using spectrometry and fluorescence. Yuan, H., Li, J., Chen, L., et al.[2022]

In a randomized controlled trial involving 60 children with post-orthodontic white spot lesions, both resin infiltration (ICON) and the remineralizing agent Casein Phospho Peptide-Amorphous Calcium Phosphate (CPP-ACP) showed significant effectiveness in reducing lesion size and improving color over a 12-month period.

Both treatment methods provided durable aesthetic improvements, indicating that either option can be effective for managing white spot lesions after orthodontic treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Post Orthodontic White Spot Lesions Using Resin Infiltration and CPP-ACP Materials- A Clinical Study. Simon, LS., Dash, JK., U, D., et al.[2022]

The study demonstrated that adding 2% casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) to a fluoride mouthrinse significantly enhances fluoride incorporation into dental plaque, which could help in preventing tooth decay.

A dentifrice with 2% CPP-ACP achieved remineralization levels comparable to a high fluoride dentifrice (2800 ppm), and the combination of 2% CPP-ACP with 1100 ppm fluoride was found to be the most effective formulation for enamel remineralization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluoride and casein phosphopeptide-amorphous calcium phosphate. Reynolds, EC., Cai, F., Cochrane, NJ., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Remineralization effect of CPP-ACP and fluoride for white spot lesions in vitro. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Combined effect of paste containing casein phosphopeptide-amorphous calcium phosphate and fluoride on enamel lesions: an in vitro pH-cycling study. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Minimally Invasive Treatment of White Spot Lesions--A Systematic Review. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Effects of casein phosphopeptide amorphous calcium fluoride phosphate paste on white spot lesions and dental plaque after orthodontic treatment: a 3-month follow-up. [2022]

5. India pubmed.ncbi.nlm.nih.gov

Remineralizing potential of CPP-ACP in white spot lesions - A systematic review. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Effects of CPP-ACP with sodium fluoride on inhibition of bovine enamel demineralization: a quantitative assessment using micro-computed tomography. [2022]

7. Iran pubmed.ncbi.nlm.nih.gov

Changes in the Concentration of Ions in Saliva and Dental Plaque after Application of CPP-ACP with and without Fluoride among 6-9 Year Old Children. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Review of casein phosphopeptides-amorphous calcium phosphate. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Influence of pastes containing casein phosphopeptide-amorphous calcium phosphate on surface of demineralized enamel. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Esthetic comparison of white-spot lesion treatment modalities using spectrometry and fluorescence. [2022]

11. Singapore pubmed.ncbi.nlm.nih.gov

Management of Post Orthodontic White Spot Lesions Using Resin Infiltration and CPP-ACP Materials- A Clinical Study. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Fluoride and casein phosphopeptide-amorphous calcium phosphate. [2022]