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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two treatments—resin infiltration and a paste with fluoride and calcium compounds (Casein Phosphopeptide - Amorphous Calcium Phosphate - Fluoride, known as MI Paste Plus or RECALDENT)—to determine which better improves white spots on teeth after braces. White spots, early signs of cavities, often appear after wearing braces and make it harder to keep teeth clean. The trial seeks participants who have finished wearing braces and notice at least one white spot on their front teeth. As an unphased trial, this study offers a unique opportunity to contribute to dental research and potentially enhance post-braces dental care.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that resin infiltration is generally well-tolerated for treating white spots on teeth. This method offers a simple and gentle way to manage early signs of cavities, such as discoloration from braces. Studies suggest it effectively prevents these spots from worsening without causing major side effects.

Similarly, a mix of Casein Phosphopeptide (CPP), Amorphous Calcium Phosphate (ACP), and fluoride is considered safe. These ingredients help rebuild tooth enamel and prevent further damage. Reports indicate they do not cause significant adverse effects.

Both treatments have been used in dental care for some time. They are designed to be safe and effective in managing early dental problems. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for white spot lesions because they offer unique approaches compared to traditional fluoride treatments. Resin infiltration works by penetrating and sealing early caries lesions, potentially stopping their progression and improving aesthetics without the need for drilling. The combination of Casein Phosphopeptide (CPP) with Amorphous Calcium Phosphate (ACP) and fluoride is designed to enhance remineralization by delivering essential minerals directly to the tooth surface, which could strengthen teeth more effectively. Both treatments aim to address early dental caries associated with orthodontic treatment, offering less invasive and more targeted solutions than conventional methods.

What evidence suggests that this trial's treatments could be effective for white spot lesions?

This trial will compare two treatments for white spot lesions (WSLs) caused by braces: resin infiltration and a combination of Casein Phosphopeptide (CPP), Amorphous Calcium Phosphate (ACP), and fluoride. Research has shown that resin infiltration effectively treats WSLs, with studies indicating it can conceal these early cavity signs for at least six years by filling and sealing tiny holes on the tooth surface, preventing further lesion development. Meanwhile, the CPP-ACP-Fluoride combination helps rebuild enamel and prevent additional damage by delivering essential minerals directly to weakened areas. Both treatments show promise in effectively managing WSLs, but they protect and restore tooth enamel in different ways. ^{1 2 6 7 8}

Who Is on the Research Team?

Ida M Kornerup, DMD, MEd

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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