White Spot Lesion of ToothPhase 4NCT03823612
Reminerlization Potential of Innovative Biomimetic Material in Caries White Spot Lesions
A Phase 4 study testing Clinpro Tooth Creme and GC tooth mousse in people with White Spot Lesion of Tooth, run by Cairo University at 1 site in Egypt.
Trial summary
to remineralize the white spot caries lesions after orthodontic treatment , the investigator will use two different materials ( Clinpro tooth creme versus Gc tooth mousse) and will compare between their effects in remineralization of white spot caries lesions. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion of Tooth
- What is being tested?
- Clinpro Tooth Creme and GC tooth mousse
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2019to 1 Oct 2019
- Phase
- Phase 4
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients should have at least one white spot caries lesion
- age from 18 to 40 years
- no gender restriction
Who cannot join
- Patients with a compromised medical history.
- Severe or active periodontal disease
- Patients with developmental hypo-calcified lesions
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Donia Mahmoud Abd El Moaty
Cairo
donia mahmoud abd el moaty, bachelor, 01220767085, donia.atta@dentistry@cu.edu.eg
nada hamada ahmed, bachelor, 01000523663, nadahamada38@gmail.com
About this study
Official title: Reminerlization Potential of Innovative Biomimetic Material Versus Casein Phosphopeptide-amorphous Calcium Phosphate in Caries White Spot Lesions "A Randomized Clinical Trial"
to remineralize the white spot caries lesions after orthodontic treatment , the investigator will use two different materials ( Clinpro tooth creme versus Gc tooth mousse) and will compare between their effects in remineralization of white spot caries lesions.
Read the detailed description
Dental caries is the localized destruction of tooth tissues by acids, especially lactic acid, produced by the fermentation of dietary carbohydrates by bacteria in dental plaque. Demineralization can be arrested or reversed when remineralization agents are applied to incipient carious or non-cavitated carious lesions. A large number of therapeutic agents including non-fluoridated products have been developed to promote enamel remineralization. The process of restoring lost mineral ions to the tooth structure and strengthening the lattice work is known as remineralization.
The development of decalcification around orthodontic brackets and bands, commonly called white spot lesions (WSLs), is often observed in patients with poor oral hygiene during treatment .In many instances, these WSLs continue to be visible after the removal of fixed appliances and after natural remineralization. The remineralized enamel crystallites are generally more resistant to decalcification and also have the same orientation as the original enamel crystallites. The early enamel lesions have a potential for remineralization with an increased resistance to further acid challenge, particularly with the use of enhanced remineralization treatments.
Recaldent™ is derived from the milk protein, casein. For many years it has been known that milk and its derivatives have a tooth protective effect. Research has shown that this activity is due to a part of the casein protein called Casein Phosphopeptide (or CPP), which carries calcium and phosphate ions in the form of Amorphous Calcium Phosphate (or ACP) which used in reminerlization of white spot caries lesions.
Clinpro tooth crème (3M ESPE) is a 0.21% w/w sodium fluoride (NaF) anti caries dentifrice that contains 950 ppm fluoride and a functionalized tricalcium phosphate (f-TCP) ingredient.One major advantage of this calcium phosphate system is that it is stable in aqueous environment and also does not affect the fluoride activity added in the dentifrices. Furthermore,it has been suggested that fluoride combination with f-TCP not only provides greater remineralization in terms of microhardness and fluoride uptake, but also decreases the dose of fluoride required to achieve the same degree of remineralization,
- Conditions
- White Spot Lesion of Tooth
- Being tested
- Clinpro Tooth Creme, GC tooth mousse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinpro Tooth CremeDrug
Also called Anti-Cavity Paste with Tri-Calcium Phosphate
The participant will be instructed to Place a pea-sized amount of Clinpro Tooth Crème on a soft bristled toothbrush and brush teeth for at least two minutes then after brushing the patient will rinse out his mouth with water and spit out. It will be used twice daily at first in the morning and before sleep.
GC tooth mousseDrug
The participant will be instructed to squeeze a small amount of GC Tooth Mousse out onto a clean finger. A cotton tip, swab or custom tray are suitable application methods as it will Applied directly onto his tooth surfaces and leave undisturbed for three minutes then he will be instructed to Spread any residual crème around the mouth with his tongue and hold for a further one to two minutes then the participant will expectorate thoroughly and if possible he should avoid rinsing. Any GC Tooth Mousse remaining in the mouth can be left to gradually dissipate. The participant will be instructed to avoid eating or drinking for 30 minutes following application.
| Study group | Role | What they receive |
|---|---|---|
| GC tooth mousse | Experimental | Drug: GC tooth mousse it contains complex of Casein Phosphopeptide,Amorphous Calcium Phosphate ( CPP-ACP ) other name: Tooth Mousse (Bio-available calcium and phosphate, without fluoride) Receives: Drug: GC tooth mousse |
| clinpro tooth creme | Active comparator | it contains 0.21% Sodium Fluoride, Anti-Cavity Paste is an advanced formula containing an innovative tri-calcium phosphate ingredient
other name:0.21% w/w Sodium Fluoride Anti-Cavity Paste with Tri-Calcium Phosphate Receives: Drug: Clinpro Tooth Creme |
What is being measured
The primary outcome is the main question the study is designed to answer.
esthetic assessment
Spectrophotometer ( L, a, b) will be used to measure the change in the shade of the white spot lesions during the study
Measured: baseline, after 1 month , 3 months and 6 months of the application
Secondary outcomes (1)
patient compliance
The participants compliance will be detected by a questionnaire by asking the patient to describe his satisfaction to the total outcome of our intervention by giving a score from 1-10
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start1 Mar 2019 (estimated)
- Primary completion1 Sep 2019 (estimated)
- Study completion1 Oct 2019 (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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, donia mahmoud abd el moaty; Doniamahmoud17@gmail.com, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823612
- Sponsor's protocol ID
- donia mahmoud
- Status last verified
- Jan 2019
- First submitted
- 28 Jan 2019
- Last updated
- 30 Jan 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 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reminerlization Potential of Innovative Biomimetic Material Versus Casein Phosphopeptide-amorphous Calcium Phosphate in Caries White Spot Lesions "A Randomized Clinical Trial"
- ClinicalTrials.gov ID
- NCT03823612
- Acronym / sponsor ID
- donia mahmoud
- Conditions
- White Spot Lesion of Tooth
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (estimated)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 1 Oct 2019 (estimated)
- First posted
- 30 Jan 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 remineralize the white spot caries lesions after orthodontic treatment , the investigator will use two different materials ( Clinpro tooth creme versus Gc tooth mousse) and will compare between their effects in remineralization of white spot caries lesions.
Detailed description
Dental caries is the localized destruction of tooth tissues by acids, especially lactic acid, produced by the fermentation of dietary carbohydrates by bacteria in dental plaque. Demineralization can be arrested or reversed when remineralization agents are applied to incipient carious or non-cavitated carious lesions. A large number of therapeutic agents including non-fluoridated products have been developed to promote enamel remineralization. The process of restoring lost mineral ions to the tooth structure and strengthening the lattice work is known as remineralization.
The development of decalcification around orthodontic brackets and bands, commonly called white spot lesions (WSLs), is often observed in patients with poor oral hygiene during treatment .In many instances, these WSLs continue to be visible after the removal of fixed appliances and after natural remineralization. The remineralized enamel crystallites are generally more resistant to decalcification and also have the same orientation as the original enamel crystallites. The early enamel lesions have a potential for remineralization with an increased resistance to further acid challenge, particularly with the use of enhanced remineralization treatments.
Recaldent™ is derived from the milk protein, casein. For many years it has been known that milk and its derivatives have a tooth protective effect. Research has shown that this activity is due to a part of the casein protein called Casein Phosphopeptide (or CPP), which carries calcium and phosphate ions in the form of Amorphous Calcium Phosphate (or ACP) which used in reminerlization of white spot caries lesions.
Clinpro tooth crème (3M ESPE) is a 0.21% w/w sodium fluoride (NaF) anti caries dentifrice that contains 950 ppm fluoride and a functionalized tricalcium phosphate (f-TCP) ingredient.One major advantage of this calcium phosphate system is that it is stable in aqueous environment and also does not affect the fluoride activity added in the dentifrices. Furthermore,it has been suggested that fluoride combination with f-TCP not only provides greater remineralization in terms of microhardness and fluoride uptake, but also decreases the dose of fluoride required to achieve the same degree of remineralization,
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GC tooth mousse | Experimental | Drug: GC tooth mousseDrug: GC tooth mousse it contains complex of Casein Phosphopeptide,Amorphous Calcium Phosphate ( CPP-ACP ) other name: Tooth Mousse (Bio-available calcium and phosphate, without fluoride) |
| clinpro tooth creme | Active comparator | Drug: Clinpro Tooth Cremeit contains 0.21% Sodium Fluoride, Anti-Cavity Paste is an advanced formula containing an innovative tri-calcium phosphate ingredient other name:0.21% w/w Sodium Fluoride Anti-Cavity Paste with Tri-Calcium Phosphate |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients should have at least one white spot caries lesion
- age from 18 to 40 years
- no gender restriction
Key exclusion criteria (3 listed)
- Patients with a compromised medical history.
- Severe or active periodontal disease
- Patients with developmental hypo-calcified lesions
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 |
|---|---|---|
| Clinpro Tooth CremeAlso: Anti-Cavity Paste with Tri-Calcium PhosphateThe participant will be instructed to Place a pea-sized amount of Clinpro Tooth Crème on a soft bristled toothbrush and brush teeth for at least two minutes then after brushing the patient will rinse out his mouth with water and spit out. It will be used twice daily at first in the morning and before sleep. | Drug | clinpro tooth creme |
| GC tooth mousseThe participant will be instructed to squeeze a small amount of GC Tooth Mousse out onto a clean finger. A cotton tip, swab or custom tray are suitable application methods as it will Applied directly onto his tooth surfaces and leave undisturbed for three minutes then he will be instructed to Spread any residual crème around the mouth with his tongue and hold for a further one to two minutes then the participant will expectorate thoroughly and if possible he should avoid rinsing. Any GC Tooth Mousse remaining in the mouth can be left to gradually dissipate. The participant will be instructed to avoid eating or drinking for 30 minutes following application. | Drug | GC tooth mousse |
Primary outcome
esthetic assessment
Time frame: baseline, after 1 month , 3 months and 6 months of the application
Spectrophotometer ( L, a, b) will be used to measure the change in the shade of the white spot lesions during the study
1 secondary outcome
patient compliance
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
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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 Phase 4 study testing Clinpro Tooth Creme and GC tooth mousse in people with White Spot Lesion of Tooth, 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 3 inclusion and 3 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 30 Jan 2019. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
esthetic assessment (time frame: baseline, after 1 month , 3 months and 6 months of the application). 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 30 Jan 2019.