White Spot LesionNCT04245787
Remineralization Potential of Curodont Repair Flouride Plus Versus CPP-ACP in Management of White Spot Lesions: Randomized Clinical Trial
A study testing Self assembling peptide with fluoride in people with White Spot Lesion, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of modern dentistry is to manage non-cavitated caries lesions non- invasively through re-mineralization process to prevent the disease progression and improve aesthetics, strength, and function. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion
- What is being tested?
- Self assembling peptide with fluoride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2020to Jul 2020
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 18 and 35 years of age female and males
- Had received conventional periodontal therapy
- Active carious white spot lesions
- No systemic diseases or concomitant medication affecting salivary flow
Who cannot join
- - Participant in another trial
- Non carious lesion (enamel hypoplasia and dental flourosis)
- Presence of abnormal oral, medical, or mental condition.
- Participants who had evidence of reduced salivary flow or significant tooth wear.
- Allergy to MI paste
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty Of Oral & Dental Medicine - Cairo University
Cairo, 00202
Omnia Amin, Master, 01272512839, omniaamin232@gmail.com
About this study
The goal of modern dentistry is to manage non-cavitated caries lesions non- invasively through re-mineralization process to prevent the disease progression and improve aesthetics, strength, and function. Re-mineralization is defined as the process that supplies calcium, phosphate and flouride ions from an external source to the tooth to convert ion deposition into crystal voids in demineralized enamel. White spot lesions should be managed using a multifactorial approach. The most important strategy is to prevent demineralization and biofilm formationand use of methodologies for remineralization of lesions .
Self-assembling peptide (P11-4) has shown great potential for natural repair of early caries lesions through emerging biomimetic re-mineralization properties. (Takahashi Fet al in 2015) This peptide forms a 3D matrix within demineralized carious lesions areas, which enables novo hydroxyapatite crystal formation facilitating the so-called guided enamel regeneration of the lost enamel structure. The peptide has shown encouraging results as a scaffold for enamel regeneration
- Conditions
- White Spot Lesion
- Being tested
- Self assembling peptide with fluoride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self assembling peptide with fluorideDrug
Also called Curodont Repair Fluoride Plus
peptide forms a 3D matrix within demineralized carious lesions areas, which enables novo hydroxyapatite crystal formation facilitating the so-called guided enamel regeneration of the lost enamel structure. The peptide has shown encouraging results as a scaffold for enamel regeneration
| Study group | Role | What they receive |
|---|---|---|
| Self assembling peptide with fluoride | Experimental | Not described Receives: Drug: Self assembling peptide with fluoride |
| Casein-phosphopeptide/amorphous-calcium phosphate | Active comparator | Not described Receives: Drug: Self assembling peptide with fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remineralization potential
by: Inspection under magnification ICDAS II Score 0:Sound tooth surface:
- First visual change in enamel.
- Distinct visual change in enamel visible when wet, lesion must be visible when dry.
Measured: T0:baseline assessment -->T1:1 month (Assessment of white spot lesion regression)--> T2:4 months(Application of Curodont repair flouride plus /Cpp-Acp andAssessment of white spot lesion regression)--> T3: 6 months Assessment of white spot lesion regres(
Secondary outcomes (1)
Remineralization potential
by: Image analysis software Change in area of the white spot lesion (mm2)
Measured: T0:baseline assessment -->T1:1 month (Assessment of white spot lesion regression)--> T2:4 months(Application of Curodont repair flouride plus /Cpp-Acp andAssessment of white spot lesion regression)--> T3: 6 months( Assessment of white spot lesion regres
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study startFeb 2020 (estimated)
- Primary completionMar 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for White Spot LesionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Hamada Ahmed Shehab Eldin, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04245787
- Sponsor's protocol ID
- p11 4
- Status last verified
- Jan 2020
- First submitted
- 27 Jan 2020
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remineralization Potential of Curodont Repair Flouride Plus Versus CPP-ACP in Management of White Spot Lesions: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04245787
- Acronym / sponsor ID
- p11 4
- Conditions
- White Spot Lesion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Feb 2020 (estimated)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 29 Jan 2020 (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.
The goal of modern dentistry is to manage non-cavitated caries lesions non- invasively through re-mineralization process to prevent the disease progression and improve aesthetics, strength, and function. Re-mineralization is defined as the process that supplies calcium, phosphate and flouride ions from an external source to the tooth to convert ion deposition into crystal voids in demineralized enamel. White spot lesions should be managed using a multifactorial approach. The most important strategy is to prevent demineralization and biofilm formationand use of methodologies for remineralization of lesions .
Self-assembling peptide (P11-4) has shown great potential for natural repair of early caries lesions through emerging biomimetic re-mineralization properties. (Takahashi Fet al in 2015) This peptide forms a 3D matrix within demineralized carious lesions areas, which enables novo hydroxyapatite crystal formation facilitating the so-called guided enamel regeneration of the lost enamel structure. The peptide has shown encouraging results as a scaffold for enamel regeneration
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self assembling peptide with fluoride | Experimental | Drug: Self assembling peptide with fluoride |
| Casein-phosphopeptide/amorphous-calcium phosphate | Active comparator | Drug: Self assembling peptide with fluoride |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Between the ages of 18 and 35 years of age female and males
- Had received conventional periodontal therapy
- Active carious white spot lesions
- No systemic diseases or concomitant medication affecting salivary flow
Key exclusion criteria (5 listed)
- - Participant in another trial
- Non carious lesion (enamel hypoplasia and dental flourosis)
- Presence of abnormal oral, medical, or mental condition.
- Participants who had evidence of reduced salivary flow or significant tooth wear.
- Allergy to MI paste
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 |
|---|---|---|
| Self assembling peptide with fluorideAlso: Curodont Repair Fluoride Pluspeptide forms a 3D matrix within demineralized carious lesions areas, which enables novo hydroxyapatite crystal formation facilitating the so-called guided enamel regeneration of the lost enamel structure. The peptide has shown encouraging results as a scaffold for enamel regeneration | Drug | Casein-phosphopeptide/amorphous-calcium phosphate, Self assembling peptide with fluoride |
Primary outcome
Remineralization potential
Time frame: T0:baseline assessment -->T1:1 month (Assessment of white spot lesion regression)--> T2:4 months(Application of Curodont repair flouride plus /Cpp-Acp andAssessment of white spot lesion regression)--> T3: 6 months Assessment of white spot lesion regres(
by: Inspection under magnification ICDAS II Score 0:Sound tooth surface: 1. First visual change in enamel. 2. Distinct visual change in enamel visible when wet, lesion must be visible when dry.
1 secondary outcome
Remineralization potential
Time frame: T0:baseline assessment -->T1:1 month (Assessment of white spot lesion regression)--> T2:4 months(Application of Curodont repair flouride plus /Cpp-Acp andAssessment of white spot lesion regression)--> T3: 6 months( Assessment of white spot lesion regres
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self assembling peptide with fluoride in people with White Spot Lesion, run by Cairo University 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 4 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: status not confirmed, as of the sponsor's last update on 29 Jan 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact omnia amin, master (01272512839, omniaamin232@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remineralization potential (time frame: T0:baseline assessment -->T1:1 month (Assessment of white spot lesion regression)--> T2:4 months(Application of Curodont repair flouride plus /Cpp-Acp andAssessment of white spot lesion regression)--> T3: 6 months Assessment of white spot lesion regres(). 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 29 Jan 2020.