RemineralizationNCT05064137
Clinical Efficacy of Different Remineralizing Agents in Treatment of White Spot Lesions
A study testing Monomeric self - assembling peptide P11-4, Tricalcium phosphate fluoride varnish, 5% F- and fluoride varnish (5% sodium fluoride) in people with Remineralization, run by Cairo University.
Trial summary
The aim of the present study is to evaluate the efficiency of Self-assembling Peptide P11-4, Tricalcium Phosphate Fluoride Varnish, 5% F- and 5% fluoride varnish in remineralization of WSLs in primary dentition among a group of Egyptian children. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Remineralization
- What is being tested?
- Monomeric self - assembling peptide P11-4, Tricalcium phosphate fluoride varnish, 5% F- and fluoride varnish (5% sodium fluoride)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2022to Jan 2023
- 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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Apparently healthy cooperative children
- Aging from 3-5 years old child
- Both genders
- Primary teeth with active WSLs on buccal or labial surfaces
- Patient and parent acceptance to treatment and maintenance of good oral hygiene
Who cannot join
- Restored teeth
- White spot lesions due to fluorosis
- Teeth with hypoplasia
- Lesions that require an invasive treatment
- Any pathology or concomitant medication affecting salivary flow or causing dry mouth
Trial locations and contacts
No sites are listed yet.
Rasha Hatem, PHD contact
About this study
Official title: Clinical Efficacy of Different Remineralizing Agents in Treatment of White Spot Lesions Among a Group of Egyptian Children : A Randomized Clinical Trial
The aim of the present study is to evaluate the efficiency of Self-assembling Peptide P11-4, Tricalcium Phosphate Fluoride Varnish, 5% F- and 5% fluoride varnish in remineralization of WSLs in primary dentition among a group of Egyptian children.
- Conditions
- Remineralization
- Being tested
- Monomeric self - assembling peptide P11-4, Tricalcium phosphate fluoride varnish, 5% F-, fluoride varnish (5% sodium fluoride)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monomeric self - assembling peptide P11-4Drug
Also called Curodont Repair
Monomeric self - assembling peptide P11-4 ( Curodont Repair ) is a remineralizing agent applied on tooth surface after treating it with 3% sodium hypochlorite for 20 seconds then etching it with 37% phosphoric acid for 20 seconds followed by rinsing then dryness.
Tricalcium phosphate fluoride varnish, 5% F-Drug
Also called 3M Clinpro white varnish
Tricalcium phosphate fluoride varnish, 5% F- ( Clinpro White Varnish ) is a remineralizing agent applied on tooth surface after mixing it with a brush onto the dosage guide.
fluoride varnish (5% sodium fluoride)Drug
Also called Voco-profluorid
fluoride varnish (5% sodium fluoride) ( Voco-profluorid ) is a remineralizing agent applied on tooth surface then area is allowed to become wet (either by gentle rinsing or natural salivary flow) to ensure setting of VOCO Profluorid Varnish.
| Study group | Role | What they receive |
|---|---|---|
| Curodont Repair® ( monomeric self - assembling peptide P11-4 ) | Experimental | Self assembling peptide P11-4 as Curodont Repair® can remineralize WSLs in a deeper manner than fluoride by guided enamel regeneration by forming a three-dimensional matrix within the subsurface body of an initial carious lesion to which calcium and phosphate ions found in natural saliva can bind and build de novo hydroxyapatite crystals. Receives: Drug: Monomeric self - assembling peptide P11-4 |
| Clinpro white varnish® ( Tricalcium Phosphate Fluoride Varnish, 5% F- ) | Experimental | Tri-calcium phosphate can be hydrolyzed rapidly to form calcium hydroxyapatite (HAp). The processes of hydrolysis and formation of HAp are accelerated by the presence of NaF ions as in case of Clinpro white varnish®. Moreover, the HAp formed by such hydrolysis tends to have a greater uptake of fluoride than conventional HAp. Receives: Drug: Tricalcium phosphate fluoride varnish, 5% F- |
| Voco-profluorid® fluoride varnish (5% sodium fluoride) | Active comparator | Fluoride varnish is the gold standard for treating WSLs. Receives: Drug: fluoride varnish (5% sodium fluoride) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Size of WSL ( white spot lesion )
Size of WSL measured by scored dental probe
Measured: through study completion, an average of 8 months
Secondary outcomes (3)
Regression of caries
Regression of caries evaluated by International Caries Detection and Assessment System (ICDAS) II
Measured: through study completion, an average of 8 months
Inactivation of active carious lesions
Inactivation of active carious lesions evaluated by Lesion activity assessment (LAA-ICDAS)
Measured: through study completion, an average of 8 months
Mineral content of WSL
Mineral content of WSL measured by fluorescence camera VistaCam iX
Measured: through study completion, an average of 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study startMar 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RemineralizationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yara Ahmed Ibrahim Abdellatif, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064137
- Sponsor's protocol ID
- 257
- Status last verified
- Feb 2022
- First submitted
- 18 Sep 2021
- Last updated
- 8 Mar 2022
- 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 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Different Remineralizing Agents in Treatment of White Spot Lesions Among a Group of Egyptian Children : A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05064137
- Acronym / sponsor ID
- 257
- Conditions
- Remineralization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 1 Oct 2021 (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 aim of the present study is to evaluate the efficiency of Self-assembling Peptide P11-4, Tricalcium Phosphate Fluoride Varnish, 5% F- and 5% fluoride varnish in remineralization of WSLs in primary dentition among a group of Egyptian children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Curodont Repair® ( monomeric self - assembling peptide P11-4 ) | Experimental | Drug: Monomeric self - assembling peptide P11-4Self assembling peptide P11-4 as Curodont Repair® can remineralize WSLs in a deeper manner than fluoride by guided enamel regeneration by forming a three-dimensional matrix within the subsurface body of an initial carious lesion to which calcium and phosphate ions found in natural saliva can bind and build de novo hydroxyapatite crystals. |
| Clinpro white varnish® ( Tricalcium Phosphate Fluoride Varnish, 5% F- ) | Experimental | Drug: Tricalcium phosphate fluoride varnish, 5% F-Tri-calcium phosphate can be hydrolyzed rapidly to form calcium hydroxyapatite (HAp). The processes of hydrolysis and formation of HAp are accelerated by the presence of NaF ions as in case of Clinpro white varnish®. Moreover, the HAp formed by such hydrolysis tends to have a greater uptake of fluoride than conventional HAp. |
| Voco-profluorid® fluoride varnish (5% sodium fluoride) | Active comparator | Drug: fluoride varnish (5% sodium fluoride)Fluoride varnish is the gold standard for treating WSLs. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Apparently healthy cooperative children
- Aging from 3-5 years old child
- Both genders
- Primary teeth with active WSLs on buccal or labial surfaces
- Patient and parent acceptance to treatment and maintenance of good oral hygiene
Key exclusion criteria (5 listed)
- Restored teeth
- White spot lesions due to fluorosis
- Teeth with hypoplasia
- Lesions that require an invasive treatment
- Any pathology or concomitant medication affecting salivary flow or causing dry mouth
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 |
|---|---|---|
| Monomeric self - assembling peptide P11-4Also: Curodont RepairMonomeric self - assembling peptide P11-4 ( Curodont Repair ) is a remineralizing agent applied on tooth surface after treating it with 3% sodium hypochlorite for 20 seconds then etching it with 37% phosphoric acid for 20 seconds followed by rinsing then dryness. | Drug | Curodont Repair® ( monomeric self - assembling peptide P11-4 ) |
| Tricalcium phosphate fluoride varnish, 5% F-Also: 3M Clinpro white varnishTricalcium phosphate fluoride varnish, 5% F- ( Clinpro White Varnish ) is a remineralizing agent applied on tooth surface after mixing it with a brush onto the dosage guide. | Drug | Clinpro white varnish® ( Tricalcium Phosphate Fluoride Varnish, 5% F- ) |
| fluoride varnish (5% sodium fluoride)Also: Voco-profluoridfluoride varnish (5% sodium fluoride) ( Voco-profluorid ) is a remineralizing agent applied on tooth surface then area is allowed to become wet (either by gentle rinsing or natural salivary flow) to ensure setting of VOCO Profluorid Varnish. | Drug | Voco-profluorid® fluoride varnish (5% sodium fluoride) |
Primary outcome
Size of WSL ( white spot lesion )
Time frame: through study completion, an average of 8 months
Size of WSL measured by scored dental probe
3 secondary outcomes
Regression of caries
Time frame: through study completion, an average of 8 months
Inactivation of active carious lesions
Time frame: through study completion, an average of 8 months
Mineral content of WSL
Time frame: through study completion, an average of 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
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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.
Rasha Hatem, PHD contact
Questions about this trial
What is this clinical trial studying?
A study testing Monomeric self - assembling peptide P11-4, Tricalcium phosphate fluoride varnish, 5% F- and fluoride varnish (5% sodium fluoride) in people with Remineralization, run by Cairo University.
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 5 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 8 Mar 2022. 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.
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 Yara A Abdellatif, BDS (00201007627551, yaraabdellatif@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Size of WSL ( white spot lesion ) (time frame: through study completion, an average of 8 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 8 Mar 2022.