White Spot Lesion of ToothRCTNCT06821724
Effect of Different Remineralizing Agents on White Spot Lesions Treatment in Children
A study testing Casein phosphopeptide-amorphous calcium phosphate, Casein phosphopeptide-amorphous calcium phosphate + fluoride and Nano hydroxyapatite paste in people with White Spot Lesion of Tooth, run by National Research Centre, Egypt at 1 site in Egypt.
Trial summary
One hundred children with white spot lesions on their teeth were divivided into 5 groups of different remineralizing agents to assess their effect on color change and remineralization Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion of Tooth
- What is being tested?
- Casein phosphopeptide-amorphous calcium phosphate, Casein phosphopeptide-amorphous calcium phosphate + fluoride and Nano hydroxyapatite paste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 1 Feb 2025
- 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 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Presence of at least one tooth affected by white spot lesion.
- Good oral hygiene and regular tooth brushing at least twice daily.
Who cannot join
- Unwillingness to be randomly assigned to 1 of the 3 treatment groups.
- Presence of abnormal oral, medical, or mental condition.
- Presence of any milk-related allergies.
- Presence of dentin caries or enamel hypoplasia on maxillary anterior teeth.
- Presence of periodontal pockets around maxillary anterior teeth.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study on the Effect of Different Remineralizing Agents Versus Fluoride Gel on White Spot Lesions After In-Office Followed by Home Treatment in Children: A Randomized Controlled Clinical Study
One hundred children with white spot lesions on their teeth were divivided into 5 groups of different remineralizing agents to assess their effect on color change and remineralization
Read the detailed description
Children having at least one tooth clinically diagnosed by white spot lesion were randomly allocated to five groups.
Group one: No treatment was applied (negative control). Group two: Fluoride gel was applied for 5 minutes (positive control). Group three: Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) (MI paste) was applied for 5 minutes.
Group four: Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) + fluoride (MI paste plus) were applied for 5 minutes.
Group five: Nano hydroxyapatite paste (Apagard primo toothpaste) was be applied for 5 minutes.
All children involved in this study were instructed to brush their teeth under the supervision of the researcher before the application of the studied agent.
Each agent was applied to the labial surfaces of each tooth affected with white spot lesion for 5 minutes after cleaning and drying with a cotton roll using an applicator tip. After each application, children were instructed not to eat or drink for one hour. This application was be repeated in-office after one then after two weeks then after six weeks.
Participants received a sterilized pouch containing a sterile container with one of the pastes according to the study group for home application. The application of the paste was carried out under parental supervision and was asked to apply each of the pastes at home three times a day till the end of the study
- Conditions
- White Spot Lesion of Tooth
- Being tested
- Casein phosphopeptide-amorphous calcium phosphate, Casein phosphopeptide-amorphous calcium phosphate + fluoride, Nano hydroxyapatite paste, Fluoride gel
- Keywords
- White spots, Remineralization, Caries, Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Casein phosphopeptide-amorphous calcium phosphateDrug
Also called (CPP-ACP) (MI paste)
Intervention
Casein phosphopeptide-amorphous calcium phosphate + fluorideDrug
Also called (CPP-ACP) + (MI paste plus)
Intervention
Nano hydroxyapatite pasteDrug
Also called (Apagard primo toothpaste)
Intervention
Fluoride gelDrug
Also called Active Comparator
Positive control
| Study group | Role | What they receive |
|---|---|---|
| No treatment | No intervention | Negative control |
| Fluoride gel | Active comparator | Positive control Receives: Drug: Fluoride gel |
| Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) (MI paste) | Experimental | Intervention Receives: Drug: Casein phosphopeptide-amorphous calcium phosphate |
| Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) + fluoride (MI paste plus) | Experimental | Intervention Receives: Drug: Casein phosphopeptide-amorphous calcium phosphate + fluoride |
| Nano hydroxyapatite paste (Apagard primo toothpaste) | Experimental | Intervention Receives: Drug: Nano hydroxyapatite paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of color change
Color change assessmentof white spot lesions using "Easy-shade" device
Measured: before treatment, immediately after treatment, 2 weeks and 6 weeks after the onset of treatment
Secondary outcomes (1)
Remineralization assessment
Remineralization assessment will be done using Laser fluorescence device "DIAGNOdent® (KaVo)".
Measured: before treatment, immediately after treatment, 2 weeks and 6 weeks after the onset of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start1 Dec 2024
- Primary completion15 Jan 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Factorial
- Model description
- Randomized controlled parallel double blinded study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Centre, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Farouk Rashed, National Research Centre, Egypt
- Investigators
- Mohamed F Rashed, Researcher, Study director, National Research Centre, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821724
- Sponsor's protocol ID
- 342
- Acronym
- RCT
- Status last verified
- Feb 2025
- First submitted
- 6 Feb 2025
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
El Mansy MM, Rashed MF, Saleh RS. Effect of remineralization after in office followed by home treatment of white spot lesions in children randomized controlled trial. Sci Rep. 2025 Aug 19;15(1):30448. doi: 10.1038/s41598-025-15829-5.
PubMed 40830200
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study on the Effect of Different Remineralizing Agents Versus Fluoride Gel on White Spot Lesions After In-Office Followed by Home Treatment in Children: A Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT06821724
- Acronym / sponsor ID
- RCT / 342
- Conditions
- White Spot Lesion of Tooth
- Keywords
- White spots, Remineralization, Caries, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- National Research Centre, EgyptUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 12 Feb 2025 (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.
One hundred children with white spot lesions on their teeth were divivided into 5 groups of different remineralizing agents to assess their effect on color change and remineralization
Detailed description
Children having at least one tooth clinically diagnosed by white spot lesion were randomly allocated to five groups.
Group one: No treatment was applied (negative control). Group two: Fluoride gel was applied for 5 minutes (positive control). Group three: Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) (MI paste) was applied for 5 minutes.
Group four: Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) + fluoride (MI paste plus) were applied for 5 minutes.
Group five: Nano hydroxyapatite paste (Apagard primo toothpaste) was be applied for 5 minutes.
All children involved in this study were instructed to brush their teeth under the supervision of the researcher before the application of the studied agent.
Each agent was applied to the labial surfaces of each tooth affected with white spot lesion for 5 minutes after cleaning and drying with a cotton roll using an applicator tip. After each application, children were instructed not to eat or drink for one hour. This application was be repeated in-office after one then after two weeks then after six weeks.
Participants received a sterilized pouch containing a sterile container with one of the pastes according to the study group for home application. The application of the paste was carried out under parental supervision and was asked to apply each of the pastes at home three times a day till the end of the study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Randomized controlled parallel double blinded study
| Arm | Type | Receives |
|---|---|---|
| No treatment | No intervention | –Negative control |
| Fluoride gel | Active comparator | Drug: Fluoride gelPositive control |
| Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) (MI paste) | Experimental | Drug: Casein phosphopeptide-amorphous calcium phosphateIntervention |
| Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) + fluoride (MI paste plus) | Experimental | Drug: Casein phosphopeptide-amorphous calcium phosphate + fluorideIntervention |
| Nano hydroxyapatite paste (Apagard primo toothpaste) | Experimental | Drug: Nano hydroxyapatite pasteIntervention |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Presence of at least one tooth affected by white spot lesion.
- Good oral hygiene and regular tooth brushing at least twice daily.
Key exclusion criteria (5 listed)
- Unwillingness to be randomly assigned to 1 of the 3 treatment groups.
- Presence of abnormal oral, medical, or mental condition.
- Presence of any milk-related allergies.
- Presence of dentin caries or enamel hypoplasia on maxillary anterior teeth.
- Presence of periodontal pockets around maxillary anterior teeth.
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 |
|---|---|---|
| Casein phosphopeptide-amorphous calcium phosphateAlso: (CPP-ACP) (MI paste)Intervention | Drug | Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) (MI paste) |
| Casein phosphopeptide-amorphous calcium phosphate + fluorideAlso: (CPP-ACP) + (MI paste plus)Intervention | Drug | Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) + fluoride (MI paste plus) |
| Nano hydroxyapatite pasteAlso: (Apagard primo toothpaste)Intervention | Drug | Nano hydroxyapatite paste (Apagard primo toothpaste) |
| Fluoride gelAlso: Active ComparatorPositive control | Drug | Fluoride gel |
Primary outcome
Assessment of color change
Time frame: before treatment, immediately after treatment, 2 weeks and 6 weeks after the onset of treatment
Color change assessmentof white spot lesions using "Easy-shade" device
1 secondary outcome
Remineralization assessment
Time frame: before treatment, immediately after treatment, 2 weeks and 6 weeks after the onset of treatment
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 12 Feb 2025.
- Derived from this study: PubMed 40830200El Mansy MM, Rashed MF, Saleh RS. Effect of remineralization after in office followed by home treatment of white spot lesions in children randomized controlled trial. Sci Rep. 2025 Aug 19;15(1):30448. doi: 10.1038/s41598-025-15829-5.
Related trials for White Spot Lesion of Tooth
Active, not recruiting
A Split-Mouth Clinical Trial Evaluating the Bond Failure Rate of a New Etch-Free Orthodontic Adhesive
Bracket Bonding, Orthodontic Treatment
Not yet recruitingObservational study
Artificial Intelligence Versus Clinical Examination in White Spot Lesions Detection, Identification, And Scoring
White Spot Lesion of Tooth
Recruiting
EFFICACY OF BIOMIN FLUORIDE VERSUS SODIUM FLUORIDE VARNISHES, WITH AND WITHOUT DIODE LASER ON WHITE SPOT LESIONS REMINERALIZATION IN PRIMARY TEETH.
White Spot Lesions [Initial Caries] on Smooth Surface of Tooth
Not yet recruiting
S-PRG Filler for Preventing White Spot Lesions During Orthodontic Treatment
White Spot Lesion of Tooth, Orthodontic Treatment
Recruiting
Clinical Investigation of the Performance of Epinamel for Dental White Spot Lesions
White Spot Lesions [Initial Caries] on Smooth Surface of Tooth
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 F Rashed, Researcher study director
National Research Centre, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Casein phosphopeptide-amorphous calcium phosphate, Casein phosphopeptide-amorphous calcium phosphate + fluoride and Nano hydroxyapatite paste in people with White Spot Lesion of Tooth, run by National Research Centre, Egypt at 1 site in Egypt.
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 2 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 12 Feb 2025. 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 Egypt. 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?
Assessment of color change (time frame: before treatment, immediately after treatment, 2 weeks and 6 weeks after the onset of treatment). 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 NCT06821724, 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 12 Feb 2025.