Caries; InitialNCT05094492
Evaluation of Remineralization Potential of Self Assembling Peptide Combined With Fluoride
A study testing Curodont Repair Fluoride Plus and Bifluorid 10 fluoride varnish in people with Caries; Initial, run by Cairo University at 1 site in Egypt.
Trial summary
Self-assembling peptide (P11-4) exhibited an outstanding ability for biomimetic re-mineralization of incipient enamel carious lesions. It creates a 3D matrix within the subsurface of carious lesions, allowing de novo formation of Hydroxyapatite crystals, thus enabling guided enamel regeneration of the demineralized… Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Caries; Initial
- What is being tested?
- Curodont Repair Fluoride Plus and Bifluorid 10 fluoride varnish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Oct 2021to 30 Jun 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 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Active carious white spot lesions.
- Patient compliance.
- Controlled oral hygiene condition.
Who cannot join
- Participant in another trial.
- Non carious lesions.
- Systemic diseases or concomitant medication affecting salivary flow.
- Cavitation of carious lesions.
- Parafunctional habits.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Cairo University
Cairo, El Manial, 11553
Omar O Shaalan, Phd, 00201122665661, omar.shaalan@dentistry.cu.edu.eg
About this study
Official title: Evaluation of Remineralization Potential of Self Assembling Peptide P11-4 Combined With Fluoride Compared to Fluoride Varnish in Management of Incipient Carious Lesions Using Laser Fluorescence: Randomized Clinical Trial
Self-assembling peptide (P11-4) exhibited an outstanding ability for biomimetic re-mineralization of incipient enamel carious lesions. It creates a 3D matrix within the subsurface of carious lesions, allowing de novo formation of Hydroxyapatite crystals, thus enabling guided enamel regeneration of the demineralized enamel structure. Addition of fluoride to P11-4 may have a synergistic effect on the remineralization potential.
Read the detailed description
This study is a randomized clinical trial, with parallel study design, 1:1 allocation ratio and superiority framework. The aim of the current trial is to evaluate remineralization potential of P11-4 combined with fluoride compared to fluoride varnish in management of incipient white spot carious lesions. Progress of the lesions will be assessed using laser fluorescence (DIAGNOdent).
- Conditions
- Caries; Initial
- Being tested
- Curodont Repair Fluoride Plus, Bifluorid 10 fluoride varnish
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curodont Repair Fluoride PlusCombination product
P11-4 self assembling peptide combined with fluoride
Bifluorid 10 fluoride varnishOther
5% Sodium Fluoride varnish (equal to 22,600 ppm fluoride)
| Study group | Role | What they receive |
|---|---|---|
| Self assembling peptide P11-4 with fluoride | Experimental | P11-4 forms a 3D matrix within subsurface of incipient carious lesions , allowing formation of new hydroxyapatite crystal facilitating guided regeneration of enamel lesions. Combination with fluoride will have a synergistic effect on remineralization potential Receives: Combination Product: Curodont Repair Fluoride Plus |
| Fluoride varnish | Active comparator | Gold standard agent for remineralization of incipient carious lesions. Receives: Other: Bifluorid 10 fluoride varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remineralization
measuring carious lesion development using DIAGNOdent laser fluorescence (scores from 0 to 99) according to progression of the carious lesion
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 posted26 Oct 2021
- Study start30 Oct 2021 (estimated)
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Caries; InitialStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Osama Shaalan, Cairo University
- Investigators
- Omar O Shaalan, PhD, Principal investigator, Lecturer, Conservative Dentistry Department, Faculty of Dentistry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094492
- Sponsor's protocol ID
- p11-4
- Status last verified
- Oct 2021
- First submitted
- 13 Oct 2021
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shaalan O, Fawzy El-Sayed K, Abouauf E. Evaluation of the remineralization potential of self-assembling peptide P11-4 with fluoride compared to fluoride varnish in the management of incipient carious lesions: a randomized controlled clinical trial. Clin Oral Investig. 2024 Jul 22;28(8):438. doi: 10.1007/s00784-024-05822-z.
PubMed 39037455
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Remineralization Potential of Self Assembling Peptide P11-4 Combined With Fluoride Compared to Fluoride Varnish in Management of Incipient Carious Lesions Using Laser Fluorescence: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05094492
- Acronym / sponsor ID
- p11-4
- Conditions
- Caries; Initial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Oct 2021 (estimated)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 26 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.
Self-assembling peptide (P11-4) exhibited an outstanding ability for biomimetic re-mineralization of incipient enamel carious lesions. It creates a 3D matrix within the subsurface of carious lesions, allowing de novo formation of Hydroxyapatite crystals, thus enabling guided enamel regeneration of the demineralized enamel structure. Addition of fluoride to P11-4 may have a synergistic effect on the remineralization potential.
Detailed description
This study is a randomized clinical trial, with parallel study design, 1:1 allocation ratio and superiority framework. The aim of the current trial is to evaluate remineralization potential of P11-4 combined with fluoride compared to fluoride varnish in management of incipient white spot carious lesions. Progress of the lesions will be assessed using laser fluorescence (DIAGNOdent).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self assembling peptide P11-4 with fluoride | Experimental | Combination Product: Curodont Repair Fluoride PlusP11-4 forms a 3D matrix within subsurface of incipient carious lesions , allowing formation of new hydroxyapatite crystal facilitating guided regeneration of enamel lesions. Combination with fluoride will have a synergistic effect on remineralization potential |
| Fluoride varnish | Active comparator | Other: Bifluorid 10 fluoride varnishGold standard agent for remineralization of incipient carious lesions. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Active carious white spot lesions.
- Patient compliance.
- Controlled oral hygiene condition.
Key exclusion criteria (6 listed)
- Participant in another trial.
- Non carious lesions.
- Systemic diseases or concomitant medication affecting salivary flow.
- Cavitation of carious lesions.
- Parafunctional habits.
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 |
|---|---|---|
| Curodont Repair Fluoride PlusP11-4 self assembling peptide combined with fluoride | Combination product | Self assembling peptide P11-4 with fluoride |
| Bifluorid 10 fluoride varnish5% Sodium Fluoride varnish (equal to 22,600 ppm fluoride) | Other | Fluoride varnish |
Primary outcome
Remineralization
Time frame: 6 months
measuring carious lesion development using DIAGNOdent laser fluorescence (scores from 0 to 99) according to progression of the carious lesion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Derived from this study: PubMed 39037455Shaalan O, Fawzy El-Sayed K, Abouauf E. Evaluation of the remineralization potential of self-assembling peptide P11-4 with fluoride compared to fluoride varnish in the management of incipient carious lesions: a randomized controlled clinical trial. Clin Oral Investig. 2024 Jul 22;28(8):438. doi: 10.1007/s00784-024-05822-z.
- Individual participant dataSharing planned: No
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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.
Omar O Shaalan, PhD principal investigator
Lecturer, Conservative Dentistry Department, Faculty of Dentistry, Cairo 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 Curodont Repair Fluoride Plus and Bifluorid 10 fluoride varnish in people with Caries; Initial, 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 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 26 Oct 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. 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 Omar O Shaalan, PhD (00201122665661, omar.shaalan@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remineralization (time frame: 6 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 NCT05094492, which also lists 1 linked publication.
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 26 Oct 2021.