White Spot LesionEarly Phase 1NCT06708481
Resin Infiltration Vs Self-Assembling Peptide (P11-4) in Treating White Spot Lesions
A Early Phase 1 study testing P11-4, a self-assembling peptide, P11-4, a self-assembling peptide with flouride and resin infilteration in people with White Spot Lesion, run by October 6 University at 1 site in Egypt.
Trial summary
Clinical assessment of the effectiveness of two treatment modalities (self-assembling peptide (P11-4) (alone or combined with fluoride) and resin infiltration) for treating white spot lesions Read more about this study
- Who is it for?
- Ages 7 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion
- What is being tested?
- P11-4, a self-assembling peptide, P11-4, a self-assembling peptide with flouride and resin infilteration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Aug 2024to Feb 2025
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 7 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age (a range from 7-14 years of age was determined)
- Good general health (absence of disease/no handicaps, to ensure oral care at home)
- Preserved pulp vitality of the teeth.
- Consolidated oral care daily.
- Agreement by patient and parents (or guardians) to participate in the study
Who cannot join
- Patients with periodontal diseases (periodontal pockets or dental mobility) or radiologically identified pathologies (periapical radiolucency).
- Teeth revealing any restorations were excluded from the current study.
- Any previous or planned WSL treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
October 6 University
Cairo, Giza Governorate
Dina EL Kharadly, PHD, 02 38355276, dina.yousry.dent@o6u.edu.eg
About this study
Official title: Clinical Outcome of Resin Infiltration Vs Self-Assembling Peptide (P11-4) in Treating White Spot Lesion - a Randomized Clinical Trial
Clinical assessment of the effectiveness of two treatment modalities (self-assembling peptide (P11-4) (alone or combined with fluoride) and resin infiltration) for treating white spot lesions
Read the detailed description
Patient/population:
Patients that range from 7-14 years of age with with at least one non-cavitated WSL located on smooth surfaces of maxillary or mandibular permanent teeth and comparable in size, opacity, and whitish appearance.
Intervention:
I1: Self-Assembling Peptide (P11-4) I2: Self-Assembling Peptide (P11-4) with fluoride varnish
Comparator Resin Infiltration
Outcome:
Primary outcome
- Esthetic Improvement of white spot lesion
Outcome measure: Photographic analysis Outcome measuring Device: Image analysis to calculate change in area ratio of WSL to the labial surface using Photoshop software.
Outcome measuring unit: change in Percentage
- Tooth remineralization
- Outcome measure: International Caries Detection and Assessment System (ICDAS) score. Outcome measuring Device: Visual and Clinical examination by operator Outcome measuring Unit : Numerical score from 0-6
- Outcome measure: Quantitative light Fluorescence score from WSL Outcome measuring Device: Diagnodent Pen Outcome measuring Unit: Numerical score from 0-99
Secondary outcome
Outcome measure: Patient Satisfaction Outcome measuring Device Likert 5-point faces scale ranging from very sad to very happy
Outcome measuring Unit :Numerical score from 1-5
Study design: Randomized clinical trial Time: 6 months
- Conditions
- White Spot Lesion
- Being tested
- P11-4, a self-assembling peptide, P11-4, a self-assembling peptide with flouride, resin infilteration
- Keywords
- Resin Infilteration , white spot lesions , Self assembling peptide, remineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P11-4, a self-assembling peptideDrug
Also called Curodont- repair
rationally designed peptide, the monomers of which self-assemble into a biocompatible fibrillar scaffold that mimics the enamel matrix in response to particular environmental cues
P11-4, a self-assembling peptide with flourideDrug
Also called Curodont- repair with fouride
self assembling peptide with 500 ppm sodium fluoride
resin infilterationDrug
Also called Icon
Improvement of white spot lesions appearance by infiltration occurs due to a change in the refractive index since the refractive index of enamel (1.62-1.65) is different than that of air (1.00). Infiltration of the lesions with an infiltrate that has a refractive index of 1.52 is able to mask the lesion
| Study group | Role | What they receive |
|---|---|---|
| Self-Assembling Peptide (P11-4) | Experimental | self-assembling peptide in a brush-on liquid applied after cleaning and chemical preparation.The P11-4 peptide, called Curodont Repair (Credentis; now manufactured by vVARDIS) Receives: Drug: P11-4, a self-assembling peptide |
| Self-Assembling Peptide (P11-4) with fluoride varnish | Experimental | CR Fluoride Plus (CRFP) (Credentis; now manufactured by vVARDIS) also includes 500 ppm sodium fluoride and is registered with the US Food and Drug Administration (NDC 72247-101) as an anticaries drug under the fluoride monograph (21CFR355). Receives: Drug: P11-4, a self-assembling peptide with flouride |
| Resin Infilteration | Active comparator | ICON® contains 15% HCl as an etchant, ethanol as a dehydrating agent, and triethylene glycol dimethacrylate (TEGDMA) resin as an infiltrant Receives: Drug: resin infilteration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esthetic Improvement of white spot lesion
Outcome Measure:
Photographic analysis
Outcome measuring device:
Image analysis to calculate change in area ratio of WSL to the labial surface using Photoshop software
Outcome measuring unit:
Percentage change
Measured: 6 months
Tooth remineralization
ICDAS score
Outcome Measure:
ICDAS score
Outcome measuring device:
Visual and Clinical examination by operator
Outcome measuring unit:
Numerical value from 0-6
Outcome Measure:
Quantitative Light Fluorescence score from WSL
Outcome measuring device:
Diagnodent pen
Outcome measuring unit:
Numerical value ranging from 0 to 99
Measured: 6 months
Secondary outcomes (1)
Patient Satisfaction
Likert 5-point faces scale ranging from very sad to very happy
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 posted27 Nov 2024
- Study start30 Aug 2024
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (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.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Collaborators
- Al-Azhar University, University of Science and Technology of Fujairah
- Responsible party
- Principal investigator, Dina El Kharadly, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708481
- Sponsor's protocol ID
- P-PD-24-03
- Status last verified
- Nov 2024
- First submitted
- 28 Aug 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome of Resin Infiltration Vs Self-Assembling Peptide (P11-4) in Treating White Spot Lesion - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06708481
- Acronym / sponsor ID
- P-PD-24-03
- Conditions
- White Spot Lesion
- Keywords
- Resin Infilteration , white spot lesions , Self assembling peptide, remineralization
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Collaborators
- Al-Azhar University, University of Science and Technology of Fujairah
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 27 Nov 2024 (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.
Clinical assessment of the effectiveness of two treatment modalities (self-assembling peptide (P11-4) (alone or combined with fluoride) and resin infiltration) for treating white spot lesions
Detailed description
Patient/population:
Patients that range from 7-14 years of age with with at least one non-cavitated WSL located on smooth surfaces of maxillary or mandibular permanent teeth and comparable in size, opacity, and whitish appearance.
Intervention:
I1: Self-Assembling Peptide (P11-4) I2: Self-Assembling Peptide (P11-4) with fluoride varnish
Comparator Resin Infiltration
Outcome:
Primary outcome
- Esthetic Improvement of white spot lesion
Outcome measure: Photographic analysis Outcome measuring Device: Image analysis to calculate change in area ratio of WSL to the labial surface using Photoshop software.
Outcome measuring unit: change in Percentage
- Tooth remineralization
- Outcome measure: International Caries Detection and Assessment System (ICDAS) score. Outcome measuring Device: Visual and Clinical examination by operator Outcome measuring Unit : Numerical score from 0-6
- Outcome measure: Quantitative light Fluorescence score from WSL Outcome measuring Device: Diagnodent Pen Outcome measuring Unit: Numerical score from 0-99
Secondary outcome
Outcome measure: Patient Satisfaction Outcome measuring Device Likert 5-point faces scale ranging from very sad to very happy
Outcome measuring Unit :Numerical score from 1-5
Study design: Randomized clinical trial Time: 6 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Self-Assembling Peptide (P11-4) | Experimental | Drug: P11-4, a self-assembling peptideself-assembling peptide in a brush-on liquid applied after cleaning and chemical preparation.The P11-4 peptide, called Curodont Repair (Credentis; now manufactured by vVARDIS) |
| Self-Assembling Peptide (P11-4) with fluoride varnish | Experimental | Drug: P11-4, a self-assembling peptide with flourideCR Fluoride Plus (CRFP) (Credentis; now manufactured by vVARDIS) also includes 500 ppm sodium fluoride and is registered with the US Food and Drug Administration (NDC 72247-101) as an anticaries drug under the fluoride monograph (21CFR355). |
| Resin Infilteration | Active comparator | Drug: resin infilterationICON® contains 15% HCl as an etchant, ethanol as a dehydrating agent, and triethylene glycol dimethacrylate (TEGDMA) resin as an infiltrant |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age (a range from 7-14 years of age was determined)
- Good general health (absence of disease/no handicaps, to ensure oral care at home)
- Preserved pulp vitality of the teeth.
- Consolidated oral care daily.
- Agreement by patient and parents (or guardians) to participate in the study
Key exclusion criteria (3 listed)
- Patients with periodontal diseases (periodontal pockets or dental mobility) or radiologically identified pathologies (periapical radiolucency).
- Teeth revealing any restorations were excluded from the current study.
- Any previous or planned WSL treatment.
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 |
|---|---|---|
| P11-4, a self-assembling peptideAlso: Curodont- repairrationally designed peptide, the monomers of which self-assemble into a biocompatible fibrillar scaffold that mimics the enamel matrix in response to particular environmental cues | Drug | Self-Assembling Peptide (P11-4) |
| P11-4, a self-assembling peptide with flourideAlso: Curodont- repair with fourideself assembling peptide with 500 ppm sodium fluoride | Drug | Self-Assembling Peptide (P11-4) with fluoride varnish |
| resin infilterationAlso: IconImprovement of white spot lesions appearance by infiltration occurs due to a change in the refractive index since the refractive index of enamel (1.62-1.65) is different than that of air (1.00). Infiltration of the lesions with an infiltrate that has a refractive index of 1.52 is able to mask the lesion | Drug | Resin Infilteration |
Primary outcome
Esthetic Improvement of white spot lesion
Time frame: 6 months
Outcome Measure: Photographic analysis Outcome measuring device: Image analysis to calculate change in area ratio of WSL to the labial surface using Photoshop software Outcome measuring unit: Percentage change
Tooth remineralization
Time frame: 6 months
ICDAS score Outcome Measure: ICDAS score Outcome measuring device: Visual and Clinical examination by operator Outcome measuring unit: Numerical value from 0-6 Outcome Measure: Quantitative Light Fluorescence score from WSL Outcome measuring device: Diagnodent pen Outcome measuring unit: Numerical value ranging from 0 to 99
1 secondary outcome
Patient Satisfaction
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing P11-4, a self-assembling peptide, P11-4, a self-assembling peptide with flouride and resin infilteration in people with White Spot Lesion, run by October 6 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 5 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: looking for participants now, as of the sponsor's last update on 27 Nov 2024. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dina El Kharadly, PHD (02 38355276, dina.yousry.dent@o6u.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Esthetic Improvement of white spot lesion (time frame: 6 months). The study lists 2 primary outcomes in all. 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 27 Nov 2024.