Ignite Creation Date:
2024-05-06 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03656432
Status:
UNKNOWN
Last Update Posted:
2018-09-06
First Post:
2018-08-30
Brief Title:
Effect of CPP-ACP WithWithout Fl on White Spot LesionSalivary pH and fl Release in High Caries Risk Patients
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Effect of CPP-ACP Pastes WithWithout Fluoride on White Spot Lesion Progression Salivary pH and Fluoride Release in High Caries Risk Patients A Randomized Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2018-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Effect of CPP-ACP pastes withwithout 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:
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 02 900 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
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 02 900 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None