White Spot LesionNCT04929509
P11-4 and Nanosilver Fluoride Varnish in Treatment of White Spot Carious Lesions
A study testing self-assembling peptide, nanosilver fluoride varnish and sodium fluoride varnish in people with White Spot Lesion, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Background: Great efforts have been undertaken for dental caries prevention. Among the recent remineralizing materials, Nano silver fluoride varnish products which are based on nanotechnology have been proposed for "repairing" enamel . Read more about this study
- Who is it for?
- Ages 10 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion
- What is being tested?
- self-assembling peptide, nanosilver fluoride varnish and sodium fluoride varnish
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Dec 2020to 1 Jan 2022
- 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 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 1- An age range of 10-24 years ( age of young adolescents and youth as described by the WHO was selected (WHO, 2019). 2. The presence of at least one visible WSL in the buccal surface of permanent teeth with ICDAS II score of 1, or 2. 3. Completion of an informed consent to participate in the study
Who cannot join
- 1. Patients receiving the following medications: tetracyclines, any other medication known to stain teeth or any medication causing dry mouth and/or limiting salivary flow. 2. Patients receiving any antibiotic within 1 month prior to each saliva sample collection 3. Selected tooth with microcavities or dentinal involvement due to loss of enamel tissues. 4. Selected tooth with a restoration adjacent to the lesions to avoid false- positive readings. 5. Selected tooth with fluoride application \< 3 months prior to study treatment. 6. Selected tooth with discolouration, enamel hypoplasia or fluorosis. 7. Patients with multiple cavitations to avoid variability in microbiological analysis.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of dentistry
Alexandria
Sara M Atteya, MDS, 01221094804, Sara.atteya@gmail.com
About this study
Official title: Effectiveness of Self-assembling Peptide (P11-4) and Nano-silver Fluoride Varnish in Management of Enamel White Spot Lesions in Young People (Randomized Controlled Clinical Trial)
Background: Great efforts have been undertaken for dental caries prevention. Among the recent remineralizing materials, Nano silver fluoride varnish products which are based on nanotechnology have been proposed for "repairing" enamel . Regenerative medicine-based approaches for caries treatment focus on biomimetic remineralization of initial carious lesions as a minimal invasive therapy using Self-Assembling Peptide P11-4 (Curodont Repair) which enhances remineralization of white spot lesions. Purpose of the Study: The aim of this study is to compare clinically and microbiologically the therapeutic effect of Self Assembling Peptide P11-4 (Curodont Repair), nano silver fluoride varnish and 5% fluoride varnish (Duraflor) on remineralization of enamel White Spot Lesions in permanent teeth of adults.
Read the detailed description
The study will be a randomized controlled double-blinded study conducted on participants aged 10 to 24 years satisfying the inclusion criteria with visible active white spot lesions on buccal surfaces of permanent teeth. Sixty six patients will be randomly allocated into 3 groups of the three materials: study group 1: one application of Curodont Repair, study group 2: one application of Nano-silver fluoride varnish and Control group twice application of Fluoride Varnish (Duraflor).
- Conditions
- White Spot Lesion
- Being tested
- self-assembling peptide, nanosilver fluoride varnish, sodium fluoride varnish
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-assembling peptideOther
Also called Curodont repair
each Curodont Repair applicator unit contains both Curolox technology for guided enamel regeneration and water for activation of the device, each box contains 10 applicators
nanosilver fluoride varnishOther
The synthesis of aqueous solution of silver nanoparticles will be carried out via the chemical reduction of silver nitrate (1 mL, 0.11 M) with sodium borohydride (0.3 mL, 0.8 M) and chitosan biopolymer (28.7 mL, 2.5 mg/mL) as a stabilizing agent. Sodium fluoride (10,147 ppm of fluorine) will be incorporated at the end of the experiment.
sodium fluoride varnishOther
Also called duraflor
5% sodium fluoride varnish; One ml of fluoride varnish contains 50 mg of sodium fluoride in an alcohol-based suspension of resins.
| Study group | Role | What they receive |
|---|---|---|
| self-assembling peptide (P11-4) | Experimental | Curodont Repair; Credentis will be applied to the
white spot lesion at baseline. Receives: Other: self-assembling peptide |
| nanosilver fluoride varnish | Active comparator | (Study group) Nano-silver fluoride varnish will be applied to the
white spot lesion at baseline. Receives: Other: nanosilver fluoride varnish |
| sodium fluoride varnish | Placebo comparator | (Control group) Fluoride varnish (Duraflor) will be applied to the
white spot lesion at baseline and 6 months follow up. Receives: Other: sodium fluoride varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the activity status of lesions scored using ICDAS-LAA
Change in the activity status of lesions scored using ICDAS-LAA from baseline to final follow up.
Measured: 12 months
Secondary outcomes (2)
Change in mean DIAGNOdent readings.
Change in mean DIAGNOdent readings from baseline to each follow up period
Measured: 12 months
Microbial count of mutans streptococci, lactobacilli.
Microbial count of mutans streptococci, lactobacilli.from baseline to each follow up period
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 posted18 Jun 2021
- Study start5 Dec 2020
- Primary completion5 Oct 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for White Spot LesionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
- Investigators
- Hala A Amer, PHD, Study director, Alexandria UniversitySusan M Saleh, PHD, Principal investigator, Alexandria UniversityYara S Selim, PHD, Principal investigator, Alexandria UniversitySara M Atteya, PHD, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929509
- Sponsor's protocol ID
- P11-4 in white spot lesions
- Status last verified
- Jun 2021
- First submitted
- 15 Jun 2021
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Atteya SM, Amer HA, Saleh SM, Safwat Y. The effect of nano silver fluoride, self-assembling peptide and sodium fluoride varnish on salivary cariogenic bacteria: a randomized controlled clinical trial. Clin Oral Investig. 2024 Feb 23;28(3):167. doi: 10.1007/s00784-024-05562-0.
PubMed 38388987Atteya SM, Amer HA, Saleh SM, Safwat Y. Self-assembling peptide and nano-silver fluoride in remineralizing early enamel carious lesions: randomized controlled clinical trial. BMC Oral Health. 2023 Aug 19;23(1):577. doi: 10.1186/s12903-023-03269-4.
PubMed 37598194
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Self-assembling Peptide (P11-4) and Nano-silver Fluoride Varnish in Management of Enamel White Spot Lesions in Young People (Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT04929509
- Acronym / sponsor ID
- P11-4 in white spot lesions
- Conditions
- White Spot Lesion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 5 Dec 2020 (actual)
- Primary completion
- 5 Oct 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 18 Jun 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.
Background: Great efforts have been undertaken for dental caries prevention. Among the recent remineralizing materials, Nano silver fluoride varnish products which are based on nanotechnology have been proposed for "repairing" enamel . Regenerative medicine-based approaches for caries treatment focus on biomimetic remineralization of initial carious lesions as a minimal invasive therapy using Self-Assembling Peptide P11-4 (Curodont Repair) which enhances remineralization of white spot lesions. Purpose of the Study: The aim of this study is to compare clinically and microbiologically the therapeutic effect of Self Assembling Peptide P11-4 (Curodont Repair), nano silver fluoride varnish and 5% fluoride varnish (Duraflor) on remineralization of enamel White Spot Lesions in permanent teeth of adults.
Detailed description
The study will be a randomized controlled double-blinded study conducted on participants aged 10 to 24 years satisfying the inclusion criteria with visible active white spot lesions on buccal surfaces of permanent teeth. Sixty six patients will be randomly allocated into 3 groups of the three materials: study group 1: one application of Curodont Repair, study group 2: one application of Nano-silver fluoride varnish and Control group twice application of Fluoride Varnish (Duraflor).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| self-assembling peptide (P11-4) | Experimental | Other: self-assembling peptideCurodont Repair; Credentis will be applied to the white spot lesion at baseline. |
| nanosilver fluoride varnish | Active comparator | Other: nanosilver fluoride varnish(Study group) Nano-silver fluoride varnish will be applied to the white spot lesion at baseline. |
| sodium fluoride varnish | Placebo comparator | Other: sodium fluoride varnish(Control group) Fluoride varnish (Duraflor) will be applied to the white spot lesion at baseline and 6 months follow up. |
Who may qualify
- Ages
- 10 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 1- An age range of 10-24 years ( age of young adolescents and youth as described by the WHO was selected (WHO, 2019). 2. The presence of at least one visible WSL in the buccal surface of permanent teeth with ICDAS II score of 1, or 2. 3. Completion of an informed consent to participate in the study
Key exclusion criteria (1 listed)
- 1. Patients receiving the following medications: tetracyclines, any other medication known to stain teeth or any medication causing dry mouth and/or limiting salivary flow. 2. Patients receiving any antibiotic within 1 month prior to each saliva sample collection 3. Selected tooth with microcavities or dentinal involvement due to loss of enamel tissues. 4. Selected tooth with a restoration adjacent to the lesions to avoid false- positive readings. 5. Selected tooth with fluoride application \< 3 months prior to study treatment. 6. Selected tooth with discolouration, enamel hypoplasia or fluorosis. 7. Patients with multiple cavitations to avoid variability in microbiological analysis.
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 peptideAlso: Curodont repaireach Curodont Repair applicator unit contains both Curolox technology for guided enamel regeneration and water for activation of the device, each box contains 10 applicators | Other | self-assembling peptide (P11-4) |
| nanosilver fluoride varnishThe synthesis of aqueous solution of silver nanoparticles will be carried out via the chemical reduction of silver nitrate (1 mL, 0.11 M) with sodium borohydride (0.3 mL, 0.8 M) and chitosan biopolymer (28.7 mL, 2.5 mg/mL) as a stabilizing agent. Sodium fluoride (10,147 ppm of fluorine) will be incorporated at the end of the experiment. | Other | nanosilver fluoride varnish |
| sodium fluoride varnishAlso: duraflor5% sodium fluoride varnish; One ml of fluoride varnish contains 50 mg of sodium fluoride in an alcohol-based suspension of resins. | Other | sodium fluoride varnish |
Primary outcome
Change in the activity status of lesions scored using ICDAS-LAA
Time frame: 12 months
Change in the activity status of lesions scored using ICDAS-LAA from baseline to final follow up.
2 secondary outcomes
Change in mean DIAGNOdent readings.
Time frame: 12 months
Microbial count of mutans streptococci, lactobacilli.
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 18 Jun 2021.
- Derived from this study: PubMed 38388987Atteya SM, Amer HA, Saleh SM, Safwat Y. The effect of nano silver fluoride, self-assembling peptide and sodium fluoride varnish on salivary cariogenic bacteria: a randomized controlled clinical trial. Clin Oral Investig. 2024 Feb 23;28(3):167. doi: 10.1007/s00784-024-05562-0.
- Derived from this study: PubMed 37598194Atteya SM, Amer HA, Saleh SM, Safwat Y. Self-assembling peptide and nano-silver fluoride in remineralizing early enamel carious lesions: randomized controlled clinical trial. BMC Oral Health. 2023 Aug 19;23(1):577. doi: 10.1186/s12903-023-03269-4.
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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.
Hala A Amer, PHD study director
Alexandria University
Susan M Saleh, PHD principal investigator
Alexandria University
Yara S Selim, PHD principal investigator
Alexandria University
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, nanosilver fluoride varnish and sodium fluoride varnish in people with White Spot Lesion, run by Hams Hamed Abdelrahman 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 1 inclusion and 1 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 18 Jun 2021. 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. Some participants in this study may receive a placebo. 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?
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?
Change in the activity status of lesions scored using ICDAS-LAA (time frame: 12 months). 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 NCT04929509, which also lists 2 linked publications.
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 18 Jun 2021.