Mutans StreptococciNCT03526315
Antimicrobial Effect of Different Pastes on Streptococcus Mutans in Children
A study testing CPP-ACP paste, Fluoride toothpaste and Both (Fluoride and CPP-ACP) in people with Mutans Streptococci and Oral Health, run by Jordan University of Science and Technology at 1 site in Jordan.
Trial summary
This study is a randomized controlled trial involving 127 children ages between 4 and 5 years to investigate the efficacy of Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP) in reducing Streptococcus mutans (S. Read more about this study
- Who is it for?
- Ages 4 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Mutans Streptococci, Oral Health
- What is being tested?
- CPP-ACP paste, Fluoride toothpaste and Both (Fluoride and CPP-ACP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteJordan
- Study dates
- Mar 2016to Oct 2016
- Phase
- Interventional
- 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 4 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy 4-5 years old children, with primary dentition, and early childhood caries/high risk caries
Who cannot join
- Milk protein (casein) sensitivity
- Patient who has taken antibiotics in the last month
- Lack in cooperation in oral examination
- Medically compromised children
- Children that have received fluoride supplement or professional topical fluoride application at least three months before or during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antimicrobial Effect of Casein Phosphopeptide Amorphous Calcium Phosphate on Streptococcus Mutans in Children
This study is a randomized controlled trial involving 127 children ages between 4 and 5 years to investigate the efficacy of Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP) in reducing Streptococcus mutans (S. mutans) bacteria, and compare that with fluoride alone, or combined use of fluoride and CPP-ACP over a 6 month period using Saliva Check Mutans kits to detect Mutans Streptococci (MS). It is expected that all used anti-cariogenic agents will have the ability to reduce the S. mutans level in different values.
Read the detailed description
Aim: The aim of this study is to investigate the efficacy of CPP-ACP in reducing S. mutans, and compare that with fluoride alone, or combined use of fluoride and CPP-ACP.
Materials and methods: This study is a randomized controlled trial involving 127 children ages between 4 and 5 years. They will be examined and chosen randomly for the study. One hundred and twenty seven children will be divided equally into three groups: Group 1 will use CPP-ACP twice daily, Group 2 will apply fluoride toothpaste twice daily, Group 3 will apply fluoridated toothpaste and CPP-ACP twice daily. Oral swabs will be collected from children to measure S. mutans levels in terms of Colony forming units (CFU) using Saliva Check Mutans kits (GC© , Asia) for this purpose. Samples will be analyzed for S. mutans colonization before antibacterial agent application (baseline) and at 3, and 6 month intervals.
Expected results: it is expected that all used anti-cariogenic agents will have the ability to reduce the S. mutans levels in different levels.
- Conditions
- Mutans Streptococci, Oral Health
- Being tested
- CPP-ACP paste, Fluoride toothpaste, Both (Fluoride and CPP-ACP)
- Keywords
- CPP-ACP paste, Fluoride toothpaste, Combined use of fluoride and CPP-ACP paste, MS reduction, Antibacterial, Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPP-ACP pasteOther
Children will brush their teeth with CPP-ACP paste twice daily.
Fluoride toothpasteOther
Children will brush their teeth with fluoridated toothpaste twice daily.
Both (Fluoride and CPP-ACP)Other
Children will brush their teeth with fluoridated toothpaste and apply CPP-ACP immediately after tooth brushing, twice daily.
| Study group | Role | What they receive |
|---|---|---|
| CPP-ACP paste | Active comparator | Casein phosphopeptide amorphous calcium phosphate is a product that contains calcium, phosphate, protein and casein. Receives: Other: CPP-ACP paste |
| Fluoride toothpaste | Active comparator | Fluoride toothpaste Receives: Other: Fluoride toothpaste |
| Both (Fluoride and CPP-ACP) | Active comparator | Fluoride toothpaste and CPP-ACP paste Receives: Other: Both (Fluoride and CPP-ACP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Streptococcus mutans levels (Colony Forming Units/CFU) using Saliva Check Mutans kits ( GC, Asia)
Changes in Streptococcus mutans after use of CPP-ACP, Fluoride or both Saliva Check Mutans kits ( GC, Asia)
Measured: 3 and 6 months
Secondary outcomes (3)
Changes in caries using the decayed, missing due to caries, filled, deciduous teeth (dmft index)
Changes in dmft after use of CPP-ACP, Fluoride or both agents over 3 and 6 months.
Measured: 3 and 6 months
Changes in caries using the decayed, missing due to caries, filled, deciduous tooth surfaces (dmfs) index
Changes in dmfs after use of CPP-ACP, Fluoride or both agents over 3 and 6 months.
Measured: 3 and 6 months
Changes in caries using the International Caries Detection and Assessment System (ICDAS) scores
Changes in ICDAS scores over 3 and 6 months.
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study startMar 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mutans StreptococciStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a randomized controlled trial involving 127 children ages between 4 and 5 years. They will be examined and chosen randomly for the study. One hundred and twenty seven children will be divided equally into three groups: Group 1 will use CPP-ACP twice daily, Group 2 will apply fluoride toothpaste twice daily, Group 3 will apply fluoridated toothpaste and CPP-ACP twice daily. Oral swabs will be collected from children to measure MS levels in terms of (CFU) using Saliva Check Mutans kits ( GC, Asia) for this purpose. Samples will be analyzed for MS colonization before antibacterial agent application (baseline) and at 3, and 6 month intervals.
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ola Al-Batayneh, MDSc, FRACDS, Principal investigator, Associate Professor in Pediatric Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526315
- Sponsor's protocol ID
- JUST
- Status last verified
- May 2018
- First submitted
- 6 Mar 2017
- Last updated
- 16 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: The data will be shared as in demographics of the study sample.
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antimicrobial Effect of Casein Phosphopeptide Amorphous Calcium Phosphate on Streptococcus Mutans in Children
- ClinicalTrials.gov ID
- NCT03526315
- Acronym / sponsor ID
- JUST
- Conditions
- Mutans Streptococci, Oral Health
- Keywords
- CPP-ACP paste, Fluoride toothpaste, Combined use of fluoride and CPP-ACP paste, MS reduction, Antibacterial, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 16 May 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.
This study is a randomized controlled trial involving 127 children ages between 4 and 5 years to investigate the efficacy of Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP) in reducing Streptococcus mutans (S. mutans) bacteria, and compare that with fluoride alone, or combined use of fluoride and CPP-ACP over a 6 month period using Saliva Check Mutans kits to detect Mutans Streptococci (MS). It is expected that all used anti-cariogenic agents will have the ability to reduce the S. mutans level in different values.
Detailed description
Aim: The aim of this study is to investigate the efficacy of CPP-ACP in reducing S. mutans, and compare that with fluoride alone, or combined use of fluoride and CPP-ACP.
Materials and methods: This study is a randomized controlled trial involving 127 children ages between 4 and 5 years. They will be examined and chosen randomly for the study. One hundred and twenty seven children will be divided equally into three groups: Group 1 will use CPP-ACP twice daily, Group 2 will apply fluoride toothpaste twice daily, Group 3 will apply fluoridated toothpaste and CPP-ACP twice daily. Oral swabs will be collected from children to measure S. mutans levels in terms of Colony forming units (CFU) using Saliva Check Mutans kits (GC© , Asia) for this purpose. Samples will be analyzed for S. mutans colonization before antibacterial agent application (baseline) and at 3, and 6 month intervals.
Expected results: it is expected that all used anti-cariogenic agents will have the ability to reduce the S. mutans levels in different levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study is a randomized controlled trial involving 127 children ages between 4 and 5 years. They will be examined and chosen randomly for the study. One hundred and twenty seven children will be divided equally into three groups: Group 1 will use CPP-ACP twice daily, Group 2 will apply fluoride toothpaste twice daily, Group 3 will apply fluoridated toothpaste and CPP-ACP twice daily. Oral swabs will be collected from children to measure MS levels in terms of (CFU) using Saliva Check Mutans kits ( GC, Asia) for this purpose. Samples will be analyzed for MS colonization before antibacterial agent application (baseline) and at 3, and 6 month intervals.
| Arm | Type | Receives |
|---|---|---|
| CPP-ACP paste | Active comparator | Other: CPP-ACP pasteCasein phosphopeptide amorphous calcium phosphate is a product that contains calcium, phosphate, protein and casein. |
| Fluoride toothpaste | Active comparator | Other: Fluoride toothpasteFluoride toothpaste |
| Both (Fluoride and CPP-ACP) | Active comparator | Other: Both (Fluoride and CPP-ACP)Fluoride toothpaste and CPP-ACP paste |
Who may qualify
- Ages
- 4 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy 4-5 years old children, with primary dentition, and early childhood caries/high risk caries
Key exclusion criteria (5 listed)
- Milk protein (casein) sensitivity
- Patient who has taken antibiotics in the last month
- Lack in cooperation in oral examination
- Medically compromised children
- Children that have received fluoride supplement or professional topical fluoride application at least three months before or during the study period.
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 pasteChildren will brush their teeth with CPP-ACP paste twice daily. | Other | CPP-ACP paste |
| Fluoride toothpasteChildren will brush their teeth with fluoridated toothpaste twice daily. | Other | Fluoride toothpaste |
| Both (Fluoride and CPP-ACP)Children will brush their teeth with fluoridated toothpaste and apply CPP-ACP immediately after tooth brushing, twice daily. | Other | Both (Fluoride and CPP-ACP) |
Primary outcome
Changes in Streptococcus mutans levels (Colony Forming Units/CFU) using Saliva Check Mutans kits ( GC, Asia)
Time frame: 3 and 6 months
Changes in Streptococcus mutans after use of CPP-ACP, Fluoride or both Saliva Check Mutans kits ( GC, Asia)
3 secondary outcomes
Changes in caries using the decayed, missing due to caries, filled, deciduous teeth (dmft index)
Time frame: 3 and 6 months
Changes in caries using the decayed, missing due to caries, filled, deciduous tooth surfaces (dmfs) index
Time frame: 3 and 6 months
Changes in caries using the International Caries Detection and Assessment System (ICDAS) scores
Time frame: 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2018.
- Individual participant dataSharing planned: No. The data will be shared as in demographics of the study sample.
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.
Ola Al-Batayneh, MDSc, FRACDS principal investigator
Associate Professor in Pediatric Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPP-ACP paste, Fluoride toothpaste and Both (Fluoride and CPP-ACP) in people with Mutans Streptococci and Oral Health, run by Jordan University of Science and Technology at 1 site in Jordan.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 16 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Streptococcus mutans levels (Colony Forming Units/CFU) using Saliva Check Mutans kits ( GC, Asia) (time frame: 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2018.