White Spot Lesion of ToothNCT03526276
Effect of Different Pastes on Remineralization of Early Caries Lesions in Primary Teeth
A study testing CPP-ACP paste, Fluoride toothpaste and Both (Fluoride and CPP-ACP) in people with White Spot Lesion of Tooth, run by Jordan University of Science and Technology at 1 site in Jordan.
Trial summary
This study is a randomized controlled trial involving 118 children ages between 4 and 5 years to assess the remineralization effect of Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP) on white spot lesions in primary teeth using Quantitative Light-induced Fluorescence (QLF) system, and compare that with… Read more about this study
- Who is it for?
- Ages 4 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion of Tooth
- 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
- 118 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 white spot lesions
Who cannot join
- Lack of cooperation in the oral examination.
- Allergies to milk protein.
- Have received a fluoride supplement or professional topical fluoride application at least 3 months before or during the study period.
- Medically compromised patient.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Fluoride and Casein Phosphopeptide-amorphous Calcium Phosphate on Remineralization of Early Caries Lesions in Primary Teeth: an in Vivo Study
This study is a randomized controlled trial involving 118 children ages between 4 and 5 years to assess the remineralization effect of Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP) on white spot lesions in primary teeth using Quantitative Light-induced Fluorescence (QLF) system, and compare that with fluoride alone or combined use of fluoride and CPP-ACP.
Read the detailed description
Aim: To assess the remineralization effect of CPP-ACP on white spot lesions in primary teeth using QLF system, and compare that with fluoride alone or combined use of fluoride and CPP-ACP.
Materials and Methods:
- Study design:
The present study is a randomized control trial (RCT).
- Study setting: The present study will be conducted at Kindergartens, Irbid, Jordan. A list of schools will be obtained from the development sector, schools will be invited to be participate in the study. Children will be randomly allocated into groups.
- Study procedure:
- Study population includes healthy children (n=118) aged between 4-5 years diagnosed with white spot lesions.
- Oral examination at baseline to record dmft and caries risk using the Caries-risk Assessment Tool (CAT) based on American Academy of Pediatric Dentistry (AAPD) guidelines will be carried out, patients will be classified as: low, moderate or high risk
- Quantitative assessment of early caries lesions will be carried out using QLF.
- Children will be randomly allocated into three groups:
Group 1: children will brush their teeth with CPP-ACP twice daily.
Group 2: children will brush their teeth with fluoridated toothpaste twice daily.
Group 3: children will brush their teeth with fluoridated toothpaste and apply CPP-ACP immediately after tooth brushing, twice daily.
The researcher will do the morning application at school, the evening application will be done at home with help of the parent. The researcher will give oral hygiene and brushing instructions to the parents and also diet advice. An oral hygiene chart will be given to monitor twice-daily tooth brushing.
- Conditions
- White Spot Lesion of Tooth
- Being tested
- CPP-ACP paste, Fluoride toothpaste, Both (Fluoride and CPP-ACP)
- Keywords
- Quantitative Laser Fluorescence (QLF), CPP-ACP paste, Fluoride toothpaste, Combined use of fluoride and CPP-ACP paste, Primary teeth
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 toothbrushing, 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.
Change in remineralization of white spot lesions using Quantitative Light-induced Fluorescence (QLF) machine
Change in remineralization of white spot lesions as indicated by changes in fluorescence levels detected by QLF after use of CPP-ACP, Fluoride or both agents over 3 and 6 months.
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 White Spot Lesion of ToothStudies 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 118 children ages between 4 and 5 years. They will be examined and chosen randomly for the study. Children will be divided equally into three groups: Group 1 will use CPP-ACP twice daily, Group 2 will apply fluoridated toothpaste twice daily, Group 3 will apply fluoridated toothpaste and CPP-ACP twice daily. Quantitative assessment of white spot lesions will be carried out using QLF before remineralizing agent application (baseline) and at 3, and 6 month intervals.
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Scientific Research Fund, Ministry of Higher Education and Research, Jordan
- Responsible party
- Sponsor
- Investigators
- Ola Al-Batayneh, MDSc, FRACDS, Principal investigator, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526276
- Sponsor's protocol ID
- 284-2015
- Status last verified
- Mar 2017
- First submitted
- 6 Mar 2017
- Last updated
- 16 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Effect of Fluoride and Casein Phosphopeptide-amorphous Calcium Phosphate on Remineralization of Early Caries Lesions in Primary Teeth: an in Vivo Study
- ClinicalTrials.gov ID
- NCT03526276
- Acronym / sponsor ID
- 284-2015
- Conditions
- White Spot Lesion of Tooth
- Keywords
- Quantitative Laser Fluorescence (QLF), CPP-ACP paste, Fluoride toothpaste, Combined use of fluoride and CPP-ACP paste, Primary teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Scientific Research Fund, Ministry of Higher Education and Research, Jordan
- Study start
- Mar 2016 (actual)
- 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 118 children ages between 4 and 5 years to assess the remineralization effect of Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP) on white spot lesions in primary teeth using Quantitative Light-induced Fluorescence (QLF) system, and compare that with fluoride alone or combined use of fluoride and CPP-ACP.
Detailed description
Aim: To assess the remineralization effect of CPP-ACP on white spot lesions in primary teeth using QLF system, and compare that with fluoride alone or combined use of fluoride and CPP-ACP.
Materials and Methods:
- Study design:
The present study is a randomized control trial (RCT).
- Study setting: The present study will be conducted at Kindergartens, Irbid, Jordan. A list of schools will be obtained from the development sector, schools will be invited to be participate in the study. Children will be randomly allocated into groups.
- Study procedure:
- Study population includes healthy children (n=118) aged between 4-5 years diagnosed with white spot lesions.
- Oral examination at baseline to record dmft and caries risk using the Caries-risk Assessment Tool (CAT) based on American Academy of Pediatric Dentistry (AAPD) guidelines will be carried out, patients will be classified as: low, moderate or high risk
- Quantitative assessment of early caries lesions will be carried out using QLF.
- Children will be randomly allocated into three groups:
Group 1: children will brush their teeth with CPP-ACP twice daily.
Group 2: children will brush their teeth with fluoridated toothpaste twice daily.
Group 3: children will brush their teeth with fluoridated toothpaste and apply CPP-ACP immediately after tooth brushing, twice daily.
The researcher will do the morning application at school, the evening application will be done at home with help of the parent. The researcher will give oral hygiene and brushing instructions to the parents and also diet advice. An oral hygiene chart will be given to monitor twice-daily tooth brushing.
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 118 children ages between 4 and 5 years. They will be examined and chosen randomly for the study. Children will be divided equally into three groups: Group 1 will use CPP-ACP twice daily, Group 2 will apply fluoridated toothpaste twice daily, Group 3 will apply fluoridated toothpaste and CPP-ACP twice daily. Quantitative assessment of white spot lesions will be carried out using QLF before remineralizing 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 white spot lesions
Key exclusion criteria (4 listed)
- Lack of cooperation in the oral examination.
- Allergies to milk protein.
- Have received a fluoride supplement or professional topical fluoride application at least 3 months before or during the study period.
- Medically compromised patient.
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 toothbrushing, twice daily. | Other | Both (Fluoride and CPP-ACP) |
Primary outcome
Change in remineralization of white spot lesions using Quantitative Light-induced Fluorescence (QLF) machine
Time frame: 3 and 6 months
Change in remineralization of white spot lesions as indicated by changes in fluorescence levels detected by QLF after use of CPP-ACP, Fluoride or both agents over 3 and 6 months.
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
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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.
Ola Al-Batayneh, MDSc, FRACDS principal investigator
Jordan University of Science and Technology
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 White Spot Lesion of Tooth, 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 4 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?
Change in remineralization of white spot lesions using Quantitative Light-induced Fluorescence (QLF) machine (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.