Dental CariesPhase 2NCT01604109
Effect of CPP-ACP Paste on Dental Caries in Primary Teeth
A Phase 2 study testing 10 % w/v CPP-ACP paste and the paste without CPP-ACP in people with Dental Caries, run by Thammasat University at 1 site in Thailand.
Trial summary
The purpose of this study is to determine if adding daily application of CPP-ACP containing paste for one year is superior to regular fluoride tooth brushing in preventing dental caries in high caries risk Thai preschool children. Read more about this study
- Who is it for?
- Ages 30 to 42 monthsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- 10 % w/v CPP-ACP paste and the paste without CPP-ACP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 296 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2010to Sep 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 42 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy Thai boys and girl aged between 2 1/2 - 3 1/2
- Normal development of dentition
- Diagnosed as high caries risk by using the Caries-risk Assessment Tool(CAT)
Who cannot join
- Chronic use of medications or antibiotics.
- Lack of cooperation in oral examination
- Milk protein allergy and/or benzoate preservatives
- Presence at baseline oral soft tissue lesion and enamel hypoplasia.
- Receive fluoride supplement and professional topical fluoride application at least three months before the beginning of study or during study period
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Dentistry, Thammasat University
Klongluang, Patumthani, 12121
About this study
Official title: Effect of CPP-ACP Paste on Dental Caries in Primary Teeth: A Randomized Trial
The purpose of this study is to determine if adding daily application of CPP-ACP containing paste for one year is superior to regular fluoride tooth brushing in preventing dental caries in high caries risk Thai preschool children.
Read the detailed description
The 6th National Oral Health Survey in Thailand 2006-2007 reported that 3-year-old children who resided in central part have the highest dental caries prevalence of 69.8 percent with dmft affecting 3.63 teeth on average. Fluoride is widely accepted as the most effective tool to caries prevention for initial caries lesions. Current best practice recommends twice-daily tooth brushing with fluoride toothpaste for dentate children.
CPP-ACP can bolster the effects of fluoridated toothpaste alone to prevent caries.Currently, almost all clinical trials have investigated the effectiveness of CPP-ACP containing products in dental caries prevention and enhancing remineralization of initial carious lesion in the permanent dentition of young adolescents. There are no clinical studies of the effect of a CPP-ACP containing product to prevent dental caries in the primary dentition of young children.
- Conditions
- Dental Caries
- Being tested
- 10 % w/v CPP-ACP paste, the paste without CPP-ACP
- Keywords
- Caries detection/diagnosis/prevention, Preventive Dentistry, Casien Phosphopeptide, Remineralization, Clinical trial
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 % w/v CPP-ACP pasteDrug
Also called Tooth Mousse
Apply once a day at school by school teacher, following fluoride toothbrushing after lunch
the paste without CPP-ACPDrug
Apply once a day at school by school teacher, following fluoride toothbrushing after lunch.
| Study group | Role | What they receive |
|---|---|---|
| Tooth Mousse | Active comparator | 10% w/v Calcium Phosphopeptide Amorphous Calcium Phosphate paste Receives: Drug: 10 % w/v CPP-ACP paste |
| placebo control paste | Placebo comparator | the paste without Calcium phosphopeptide - Amorphous Calcium Phosphate Receives: Drug: the paste without CPP-ACP |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Mean Number of Enamel Carious Lesion
tooth surface that was classified as ICDAS code 1-3
Measured: one calender year
Secondary outcomes (1)
Quantitative Light-induced Fluorescence (QLF) Parameters
percent fluorescence loss, lesion area, lesion volume
Measured: one calender year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2012 (estimated)
- Study startJul 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Responsible party
- Principal investigator, Thanya Sitthisettapong, Thammasat University
- Investigators
- Thanya Sitthisettapong, Principal investigator, Faculty of Dentistry, Thammasat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01604109
- Sponsor's protocol ID
- TU-Dent-01
- Other IDs
- D43TW007768
- Status last verified
- Jun 2013
- First submitted
- 19 May 2012
- Last updated
- 15 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Sitthisettapong T, Phantumvanit P, Huebner C, Derouen T. Effect of CPP-ACP paste on dental caries in primary teeth: a randomized trial. J Dent Res. 2012 Sep;91(9):847-52. doi: 10.1177/0022034512454296. Epub 2012 Jul 17.
PubMed 22805294
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of CPP-ACP Paste on Dental Caries in Primary Teeth: A Randomized Trial
- ClinicalTrials.gov ID
- NCT01604109
- Acronym / sponsor ID
- TU-Dent-01
- Conditions
- Dental Caries
- Keywords
- Caries detection/diagnosis/prevention, Preventive Dentistry, Casien Phosphopeptide, Remineralization, Clinical trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Study start
- Jul 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 23 May 2012 (estimated)
- Results
- Posted 15 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if adding daily application of CPP-ACP containing paste for one year is superior to regular fluoride tooth brushing in preventing dental caries in high caries risk Thai preschool children.
Detailed description
The 6th National Oral Health Survey in Thailand 2006-2007 reported that 3-year-old children who resided in central part have the highest dental caries prevalence of 69.8 percent with dmft affecting 3.63 teeth on average. Fluoride is widely accepted as the most effective tool to caries prevention for initial caries lesions. Current best practice recommends twice-daily tooth brushing with fluoride toothpaste for dentate children.
CPP-ACP can bolster the effects of fluoridated toothpaste alone to prevent caries.Currently, almost all clinical trials have investigated the effectiveness of CPP-ACP containing products in dental caries prevention and enhancing remineralization of initial carious lesion in the permanent dentition of young adolescents. There are no clinical studies of the effect of a CPP-ACP containing product to prevent dental caries in the primary dentition of young children.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tooth Mousse | Active comparator | Drug: 10 % w/v CPP-ACP paste10% w/v Calcium Phosphopeptide Amorphous Calcium Phosphate paste |
| placebo control paste | Placebo comparator | Drug: the paste without CPP-ACPthe paste without Calcium phosphopeptide - Amorphous Calcium Phosphate |
Who may qualify
- Ages
- 30 to 42 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy Thai boys and girl aged between 2 1/2 - 3 1/2
- Normal development of dentition
- Diagnosed as high caries risk by using the Caries-risk Assessment Tool(CAT)
Key exclusion criteria (5 listed)
- Chronic use of medications or antibiotics.
- Lack of cooperation in oral examination
- Milk protein allergy and/or benzoate preservatives
- Presence at baseline oral soft tissue lesion and enamel hypoplasia.
- Receive fluoride supplement and professional topical fluoride application at least three months before the beginning of study or during 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 |
|---|---|---|
| 10 % w/v CPP-ACP pasteAlso: Tooth MousseApply once a day at school by school teacher, following fluoride toothbrushing after lunch | Drug | Tooth Mousse |
| the paste without CPP-ACPApply once a day at school by school teacher, following fluoride toothbrushing after lunch. | Drug | placebo control paste |
Primary outcome
the Mean Number of Enamel Carious Lesion
Time frame: one calender year
tooth surface that was classified as ICDAS code 1-3
1 secondary outcome
Quantitative Light-induced Fluorescence (QLF) Parameters
Time frame: one calender year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22805294Sitthisettapong T, Phantumvanit P, Huebner C, Derouen T. Effect of CPP-ACP paste on dental caries in primary teeth: a randomized trial. J Dent Res. 2012 Sep;91(9):847-52. doi: 10.1177/0022034512454296. Epub 2012 Jul 17.
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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.
Thanya Sitthisettapong principal investigator
Faculty of Dentistry, Thammasat University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 10 % w/v CPP-ACP paste and the paste without CPP-ACP in people with Dental Caries, run by Thammasat University at 1 site in Thailand.
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 3 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 15 Aug 2013. 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 Thailand. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
the Mean Number of Enamel Carious Lesion (time frame: one calender year). 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 NCT01604109, which also lists 1 linked publication.
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 15 Aug 2013.