White Spot Lesion of ToothPhase 2NCT03973554
Caries Prevention Potential of Pearl Powder Versus CPP-ACP on Enamel White Spot Lesions
A Phase 2 study testing pearl powder and CPP-ACP in people with White Spot Lesion of Tooth, run by Ruba Alaa El Din Adel El Damarisy.
Trial summary
to evaluate the caries prevention potential of pearl powder against CPP-ACP in enamel white spot lesions. Read more about this study
- Who is it for?
- Ages 12 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion of Tooth
- What is being tested?
- pearl powder and CPP-ACP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2019to 30 Oct 2021
- Phase
- Phase 2
- 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 12 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- good oral hygiene
- cooperative patient
- completion of orthodontic therapy
- presence of at least two white spot lesions on the labial surface of six maxillary anterior teeth, that were not present before orthodontic treatment
Who cannot join
- bad oral hygiene
- lack of patients compliance
- allergy to milk products
- pregnant or lactating women
- presence of dentin caries, restorations, or enamel hypoplasia on maxillary anterior teeth
- presence of periodontal pockets around maxillary anterior teeth
Trial locations and contacts
No sites are listed yet.
omar shaalan, lecturer contact
About this study
Official title: Caries Prevention Potential of Pearl Powder Versus Casein Phosphopeptide-amorphous Calcium Phosphate on Enamel White Spot Lesions: Randomized Clinical Trial.
to evaluate the caries prevention potential of pearl powder against CPP-ACP in enamel white spot lesions.
Read the detailed description
The aim of the study is to evaluate the caries prevention potential of pearl powder against CPP-ACP in enamel White Spot Lesions using laser fluorescence device scoring from 0 to 99, with daily application time of 3 months and follow up period of 6,9,and 12 months.
- Conditions
- White Spot Lesion of Tooth
- Being tested
- pearl powder, CPP-ACP
- Keywords
- white spot lesions,, pearl powder, CPP-ACP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pearl powderOther
natural product, support bone and joint health
CPP-ACPDrug
Also called tooth mousse
Remineralising sugar free dental topical crème, containing bio-available calcium and phosphate
| Study group | Role | What they receive |
|---|---|---|
| pearl powder | Experimental | natural product, support bone and joint health Receives: Other: pearl powder |
| CPP-ACP | Active comparator | product for professional use containing the active ingredient (CPP-ACP), a special milk-derived protein that has a unique ability to release bio-available calcium and phosphate to tooth surfaces. Receives: Drug: CPP-ACP |
What is being measured
The primary outcome is the main question the study is designed to answer.
caries prevention in enamel white spot lesion
caries prevention using laser fluorescence device
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start30 Oct 2019 (estimated)
- Primary completion30 Oct 2020 (estimated)
- Study completion30 Oct 2021 (estimated)
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruba Alaa El Din Adel El Damarisy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ruba Alaa El Din Adel El Damarisy, Cairo University
- Investigators
- Ruba A El Damarisy, MDS, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973554
- Sponsor's protocol ID
- 11090
- Status last verified
- Jun 2019
- First submitted
- 1 Jun 2019
- Last updated
- 7 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caries Prevention Potential of Pearl Powder Versus Casein Phosphopeptide-amorphous Calcium Phosphate on Enamel White Spot Lesions: Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03973554
- Acronym / sponsor ID
- 11090
- Conditions
- White Spot Lesion of Tooth
- Keywords
- white spot lesions,, pearl powder, CPP-ACP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Ruba Alaa El Din Adel El DamarisyUniversity, hospital or other
- Study start
- 30 Oct 2019 (estimated)
- Primary completion
- 30 Oct 2020 (estimated)
- Study completion
- 30 Oct 2021 (estimated)
- First posted
- 4 Jun 2019 (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.
to evaluate the caries prevention potential of pearl powder against CPP-ACP in enamel white spot lesions.
Detailed description
The aim of the study is to evaluate the caries prevention potential of pearl powder against CPP-ACP in enamel White Spot Lesions using laser fluorescence device scoring from 0 to 99, with daily application time of 3 months and follow up period of 6,9,and 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pearl powder | Experimental | Other: pearl powdernatural product, support bone and joint health |
| CPP-ACP | Active comparator | Drug: CPP-ACPproduct for professional use containing the active ingredient (CPP-ACP), a special milk-derived protein that has a unique ability to release bio-available calcium and phosphate to tooth surfaces. |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- good oral hygiene
- cooperative patient
- completion of orthodontic therapy
- presence of at least two white spot lesions on the labial surface of six maxillary anterior teeth, that were not present before orthodontic treatment
Key exclusion criteria (6 listed)
- bad oral hygiene
- lack of patients compliance
- allergy to milk products
- pregnant or lactating women
- presence of dentin caries, restorations, or enamel hypoplasia on 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 |
|---|---|---|
| pearl powdernatural product, support bone and joint health | Other | pearl powder |
| CPP-ACPAlso: tooth mousseRemineralising sugar free dental topical crème, containing bio-available calcium and phosphate | Drug | CPP-ACP |
Primary outcome
caries prevention in enamel white spot lesion
Time frame: 12 months
caries prevention using laser fluorescence device
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2019.
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.
omar shaalan, lecturer contact
Ruba A El Damarisy, MDS principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pearl powder and CPP-ACP in people with White Spot Lesion of Tooth, run by Ruba Alaa El Din Adel El Damarisy.
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 4 inclusion and 6 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 7 Jun 2019. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruba A El Damarisy, MDS (01222308685, eldamarisyruba@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
caries prevention in enamel white spot lesion (time frame: 12 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 7 Jun 2019.