Effect of CPP-ACP With/Without Fl on White Spot Lesion,Salivary pH and fl Release in High Caries Risk Patients

Study Overview
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Brief Summary
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Effect of CPP-ACP pastes with/without Fluoride on White spot lesion progression, salivary pH and fluoride release in high caries risk Patients, over 3 month period using VistaCam, Digital pH meter and Selective ion electrode.

Detailed Description
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Dental caries is the most prevalent disease affecting the Human beings, it is a complex disease affecting teeth, which is caused by imbalance between demineralization and remineralization process in the oral cavity. Preventive measures will stop the development of early caries lesions or even will direct the progression of this early carious lesions towards remineralization. Nowadays, researchers have focused on non-invasive techniques to prevent early caries lesions appearance. In recent years, a calcium and phosphate remineralization technology has been introduced to decrease their incidence that relies on Casein Phospho-Peptide-Amorphous Calcium Phosphate (CPP-ACP). The complex CPP-ACP derived from a milk protein called casein. CPP-ACP represents an alternative remineralizing agent that prevents the early demineralization, it is capable of stabilizing calcium phosphate, maintaining the supersaturation of these ions in the oral environment by binding with them and transport them in the form of amorphous calcium phosphate. They can enhance remineralization, decrease demineralization or even both in an acid challenge to teeth surfaces. CPP-ACP with sodium fluoride 0.2% (900 ppm) that is very similar to the amount of fluoride in the toothpaste binds to the tooth surfaces and plaque and provides biocompatible calcium, phosphate and fluoride in a localized way. So, it provides all the ions needed to build fluorapatite crystals that are more resistant to the acid attack compared to hydroxyapatite . It also has a preventive role in the pH control as it might be able to improve pH levels in different areas in the oral cavity. Early enamel demineralization is frequently observed as white spot lesions (WSLs) which are opaque enamel areas created by mineral loss from the subsurface layer of enamel. These areas are also defined as incipient or enamel caries. WSLs are the precursors for caries cavities and their milky color may cause esthetic problems . Taking into consideration that caries detection by eyesight is better for cavitated lesions than for non-cavitated early lesions. Moreover, the visual examination is a subjective method and so it has a lower reproducibility in detecting occlusal caries. Also, radiographic examination has shown high specificity and poor sensitivity for non-cavitated lesions, underestimating the lesion depth . Therefore, the detection of these early carious lesions (WSL) in the initial stage with optimum efficiency achieved by a variety of technologies one of them is the use of autofluorescence technique (VistaCam) for the early detection and diagnosis of these 8 incipient lesions . Studies have shown that white spot lesions can take only one month to develop . The VistaCam is an intraoral fluorescence camera that illuminates teeth with a violet light (405 nm) and captures the reflected light as a digital image. Which is then is filtered contains the green yellow fluorescence of normal teeth with a peak at 510 nm, as well as the red fluorescence of bacterial metabolites with a peak at 680 nm. The software quantifies the green and red fluorescent light on a scale from 0 to 3 as a ratio of red to green, showing the areas with a higher than healthy tooth ratio . Although promising, investigations dealing with the effect of CPP-ACP products on plaque and salivary pH levels and in the high caries risk patient appear to be limited and have not been conducted in the form of randomized clinical trials. Therefore, the purpose of this study was to evaluate the effects of recommending a CPP-ACPF product on salivary pH levels and measuring the amount of fluoride remains in the saliva after using it in high caries risk patients, and also monitoring the prevention of new white spot lesions during the use of CPP_ACP with and without fluoride by using the vistaCam as a randomized clinical trial.

Official Title
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Effect of CPP-ACP Pastes With/Without Fluoride on White Spot Lesion Progression, Salivary pH and Fluoride Release in High Caries Risk Patients A Randomized Clinical Trial

Conditions
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Caries

Intervention / Treatment
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* Drug: CPP-ACP paste


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age range from 17-30 years Males or females High caries risk patients defined according to American Dental Association (ADA) Systematically healthy Not taking any medication interfering with saliva secretion Co-operative patients approving to participate in the trial signed informed consent Exclusion Criteria: Patients younger than 17 years old or older than 30 years old. Disabilities Subjects suffering from any medical or systematic disease Smokers Pregnant females Allergy to milk derivatives. using any other agents containing fluoride presence of untreated caries lesions.

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPP-ACP paste<br>MI Paste represents an alternative remineralizing agent that prevents the early demineralization, it is capable of stabilizing calcium phosphate, maintaining the supersaturation of these ions in the oral environment by binding with them and transport them in the form of amorphous calcium phosphate. They can enhance remineralization, decrease demineralization or even both in an acid challenge to teeth surfaces. | Drug: CPP-ACP paste<br>* The complex CPP-ACP derived from a milk protein called casein. CPP-ACP represents an alternative remineralizing agent that prevents the early demineralization, it is capable of stabilizing calcium phosphate, maintaining the supersaturation of these ions in the oral environment by binding with them and transport them in the form of amorphous calcium phosphate. They can enhance remineralization, decrease demineralization or even both in an acid challenge to teeth surfaces.<br>* Other names: CPP-ACP containing fluoride paste;|
| Experimental: CPP-ACP containing fluoride<br>MI paste plus contains fluoride 0.2% (900 ppm) that is very similar to the amount of fluoride in the toothpaste binds to the tooth surfaces and plaque and provides biocompatible calcium, phosphate and fluoride in a localized way. So, it provides all the ions needed to build fluorapatite crystals that are more resistant to the acid attack compared to hydroxyapatite | Drug: CPP-ACP paste<br>* The complex CPP-ACP derived from a milk protein called casein. CPP-ACP represents an alternative remineralizing agent that prevents the early demineralization, it is capable of stabilizing calcium phosphate, maintaining the supersaturation of these ions in the oral environment by binding with them and transport them in the form of amorphous calcium phosphate. They can enhance remineralization, decrease demineralization or even both in an acid challenge to teeth surfaces.<br>* Other names: CPP-ACP containing fluoride paste;|
| Active Comparator: toothpaste contains fluoride<br>Fluoridated Toothpaste are the most significant and worldwide spread forms of caries control used globally as the greater acceptability of toothpaste makes its regular use more likely, thereby improving effectiveness | Drug: CPP-ACP paste<br>* The complex CPP-ACP derived from a milk protein called casein. CPP-ACP represents an alternative remineralizing agent that prevents the early demineralization, it is capable of stabilizing calcium phosphate, maintaining the supersaturation of these ions in the oral environment by binding with them and transport them in the form of amorphous calcium phosphate. They can enhance remineralization, decrease demineralization or even both in an acid challenge to teeth surfaces.<br>* Other names: CPP-ACP containing fluoride paste;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| White Spot Lesion (WSL) progression | The researcher will inspect the development of any new WSLs in the oral cavity in the clinic of Conservative Dentistry Department Cairo University. The software quantifies the green and red fluorescent light on a scale from 0 to 3 as a ratio of red to green, showing the areas with a higher than healthy tooth ratio. | (T1) baseline before application, (T2) immediate after application, (T3) 1 day, (T4) 1 week and (T5) 1 month. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| unstimulated Salivary pH change | The researcher will collect unstimulated saliva pH samples from outpatient clinic at Conservative Dentistry Department Cairo University which will be measured immediately using digital pH meter. It has no measuring unit, but it only displays numerical value. | (T1) baseline before application, (T2) immediate after application, (T3) 1 day, (T4) 1 week and (T5) 1 month. | 
| stimulated Fluoride Release | The researcher will collect stimulated salivary sample from the participant for fluoride release measurement by selective ion electrode in ppm(mg/l). | For the WSLs assessment, (T1) baseline before application, (T2) 1 month and (T3) 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CPP-ACP pastes, CPP_ACPF, Fluoride release, early carious lesion