CariesPhase 3NCT03656432
Effect of CPP-ACP With/Without Fl on White Spot Lesion,Salivary pH and fl Release in High Caries Risk Patients
A Phase 3 study testing CPP-ACP paste in people with Caries, run by Cairo University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 17 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries
- What is being tested?
- CPP-ACP paste
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Oct 2018to Jun 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
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.
Read the 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 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.
- Conditions
- Caries
- Being tested
- CPP-ACP paste
- Keywords
- CPP-ACP pastes, CPP_ACPF, Fluoride release, early carious lesion
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPP-ACP pasteDrug
Also called CPP-ACP containing fluoride paste
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.
| Study group | Role | What they receive |
|---|---|---|
| CPP-ACP paste | Experimental | 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. Receives: Drug: CPP-ACP paste |
| CPP-ACP containing fluoride | Experimental | 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 Receives: Drug: CPP-ACP paste |
| toothpaste contains fluoride | Active comparator | 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 Receives: Drug: CPP-ACP paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: (T1) baseline before application, (T2) immediate after application, (T3) 1 day, (T4) 1 week and (T5) 1 month.
Secondary outcomes (2)
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.
Measured: (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).
Measured: For the WSLs assessment, (T1) baseline before application, (T2) 1 month and (T3) 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study startOct 2018 (estimated)
- Primary completionApr 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CariesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Gamal, Cairo University
- Investigators
- Mohamed R Farid, PhD, Study director, Professor of Conservative Dentistry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03656432
- Sponsor's protocol ID
- CEBD-CU-2018-08-29
- Status last verified
- Sep 2018
- First submitted
- 30 Aug 2018
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Poureslami H, Hoseinifar R, Khazaeli P, Hoseinifar R, Sharifi H, Poureslami P. 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. J Dent Biomater. 2017 Mar;4(1):361-366.
PubMed 28959766Sinfiteli PP, Coutinho TCL, Oliveira PRA, Vasques WF, Azevedo LM, Pereira AMB, Tostes MA. Effect of fluoride dentifrice and casein phosphopeptide-amorphous calcium phosphate cream with and without fluoride in preventing enamel demineralization in a pH cyclic study. J Appl Oral Sci. 2017 Nov-Dec;25(6):604-611. doi: 10.1590/1678-7757-2016-0559.
PubMed 29211281Heshmat H, Banava S, Mohammadi E, Kharazifard MJ, Mojtahedzadeh F. The effect of recommending a CPP-ACPF product on salivary and plaque pH levels in orthodontic patients: a randomized cross-over clinical trial. Acta Odontol Scand. 2014 Nov;72(8):903-7. doi: 10.3109/00016357.2014.920515. Epub 2014 May 26.
PubMed 24856191Ebrahimi M, Mehrabkhani M, Ahrari F, Parisay I, Jahantigh M. The effects of three remineralizing agents on regression of white spot lesions in children: A two-week, single-blind, randomized clinical trial. J Clin Exp Dent. 2017 May 1;9(5):e641-e648. doi: 10.4317/jced.53582. eCollection 2017 May.
PubMed 28512540Tassery H, Levallois B, Terrer E, Manton DJ, Otsuki M, Koubi S, Gugnani N, Panayotov I, Jacquot B, Cuisinier F, Rechmann P. Use of new minimum intervention dentistry technologies in caries management. Aust Dent J. 2013 Jun;58 Suppl 1:40-59. doi: 10.1111/adj.12049.
PubMed 23721337
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03656432
- Acronym / sponsor ID
- CEBD-CU-2018-08-29
- Conditions
- Caries
- Keywords
- CPP-ACP pastes, CPP_ACPF, Fluoride release, early carious lesion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2018 (estimated)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 4 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CPP-ACP paste | Experimental | Drug: CPP-ACP pasteMI 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. |
| CPP-ACP containing fluoride | Experimental | Drug: CPP-ACP pasteMI 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 |
| toothpaste contains fluoride | Active comparator | Drug: CPP-ACP pasteFluoridated 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 |
Who may qualify
- Ages
- 17 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- Patients younger than 17 years old or older than 30 years old.
- Disabilities
- Subjects suffering from any medical or systematic disease
- Smokers
- Pregnant females
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPP-ACP pasteAlso: CPP-ACP containing fluoride pasteThe 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. | Drug | CPP-ACP containing fluoride, CPP-ACP paste, toothpaste contains fluoride |
Primary outcome
White Spot Lesion (WSL) progression
Time frame: (T1) baseline before application, (T2) immediate after application, (T3) 1 day, (T4) 1 week and (T5) 1 month.
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.
2 secondary outcomes
unstimulated Salivary pH change
Time frame: (T1) baseline before application, (T2) immediate after application, (T3) 1 day, (T4) 1 week and (T5) 1 month.
stimulated Fluoride Release
Time frame: For the WSLs assessment, (T1) baseline before application, (T2) 1 month and (T3) 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- Background: PubMed 28959766Poureslami H, Hoseinifar R, Khazaeli P, Hoseinifar R, Sharifi H, Poureslami P. 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. J Dent Biomater. 2017 Mar;4(1):361-366.
- Background: PubMed 29211281Sinfiteli PP, Coutinho TCL, Oliveira PRA, Vasques WF, Azevedo LM, Pereira AMB, Tostes MA. Effect of fluoride dentifrice and casein phosphopeptide-amorphous calcium phosphate cream with and without fluoride in preventing enamel demineralization in a pH cyclic study. J Appl Oral Sci. 2017 Nov-Dec;25(6):604-611. doi: 10.1590/1678-7757-2016-0559.
- Background: PubMed 24856191Heshmat H, Banava S, Mohammadi E, Kharazifard MJ, Mojtahedzadeh F. The effect of recommending a CPP-ACPF product on salivary and plaque pH levels in orthodontic patients: a randomized cross-over clinical trial. Acta Odontol Scand. 2014 Nov;72(8):903-7. doi: 10.3109/00016357.2014.920515. Epub 2014 May 26.
- Background: PubMed 28512540Ebrahimi M, Mehrabkhani M, Ahrari F, Parisay I, Jahantigh M. The effects of three remineralizing agents on regression of white spot lesions in children: A two-week, single-blind, randomized clinical trial. J Clin Exp Dent. 2017 May 1;9(5):e641-e648. doi: 10.4317/jced.53582. eCollection 2017 May.
- Background: PubMed 23721337Tassery H, Levallois B, Terrer E, Manton DJ, Otsuki M, Koubi S, Gugnani N, Panayotov I, Jacquot B, Cuisinier F, Rechmann P. Use of new minimum intervention dentistry technologies in caries management. Aust Dent J. 2013 Jun;58 Suppl 1:40-59. doi: 10.1111/adj.12049.
- Topical Tooth Créme Containing Calcium, Phosphate \& FluorideLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed R Farid, PhD study director
Professor of Conservative Dentistry, Cairo University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CPP-ACP paste in people with Caries, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Doaa G Ashour, Master (01006512932 ext. +20, Doaa.Gamal@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
White Spot Lesion (WSL) progression (time frame: (T1) baseline before application, (T2) immediate after application, (T3) 1 day, (T4) 1 week and (T5) 1 month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03656432, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2018.