Dental Caries Tooth DemineralizationNCT07146464
Evaluation of Self-assembling Peptides Versus Amorphous Calcium Phosphate in the Treatment of White Spot Lesions
A study testing Self-Assembling Peptide P11-4 Self-Assembling Peptide P11-4 is a biomimetic material applied topically to white spot lesions on the enamel. It diffuses into the lesion body and forms a three-dimension in people with Dental Caries Tooth Demineralization and Post-Orthodontic Esthetic Defects, run by Ain Shams University at 1 site in Egypt.
Trial summary
This clinical trial aims to compare the effectiveness of two remineralizing treatments for white spot lesions (WSLs) on the enamel surfaces of the front teeth. WSLs are early signs of tooth decay, often appearing after orthodontic treatment with braces. Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- Dental Caries Tooth Demineralization, Post-Orthodontic Esthetic Defects
- What is being tested?
- Self-Assembling Peptide P11-4 Self-Assembling Peptide P11-4 is a biomimetic material applied topically to white spot lesions on the enamel. It diffuses into the lesion body and forms a three-dimension
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Mar 2024to Jun 2026
- Phase
- Interventional
- 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 15 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 15 and 25 years
- Presence of at least one tooth on each side of the anterior region (from right canine to left canine) affected by early carious lesions (ICDAS II code 1 or 2)
- Lesion size and form must be fully visible and accessible
- Willing and able to attend all study visits and follow instructions
- Good general health and oral hygiene
- Not taking any medication that affects salivary flow
- Provided written informed consent
Who cannot join
- Evidence of tooth erosion
- Prior fluoride varnish application before study treatment
- Hypoplastic enamel defects or multiple restorations on facial surfaces of anterior teeth
- High caries risk patients
- Known or suspected allergy to milk proteins
- Use of medications affecting salivary flow
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
Faculty of Dentistry, Ain Shams University
Cairo, Cairo Governorate
faculty of Dentistry, Ain Shams University, 01002229647, amany-mohamed@dent.asu.edu.eg
About this study
Official title: Evaluation of Self Assembling Peptides Versus Amorphous Calcium Phosphate in the Treatment of White Spot Lesions; Split Mouth Randomized Clinical Trial
This clinical trial aims to compare the effectiveness of two remineralizing treatments for white spot lesions (WSLs) on the enamel surfaces of the front teeth. WSLs are early signs of tooth decay, often appearing after orthodontic treatment with braces. These white spots may persist for years and affect the esthetic appearance of teeth.
The study will include male and female patients aged 15 to 25 who have at least one early carious lesion (ICDAS scores 1 or 2) on each side of their upper or lower front teeth. The purpose is to determine which treatment - Self-Assembling Peptides (SAP P11-4, Curodont Repair™) or Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP, MI Varnish™) - is more effective in improving the color and reducing the size of these lesions.
Read more
Researchers will use a split-mouth design, where each patient receives both treatments - one on each side of the mouth. Standardized digital photographs will be taken before and after treatment to assess color changes and lesion size. Patients will also rate their satisfaction with the appearance of their teeth after treatment.
The main questions the study will answer are:
Does SAP P11-4 improve the color of white spot lesions more effectively than CPP-ACP?
Is there a noticeable difference in lesion size reduction between the two treatments?
How satisfied are patients with the outcomes of each treatment?
Participants will be followed up at 3, 6, and 9 months after treatment. The results aim to guide clinicians toward the most effective treatment to improve the appearance of white spot lesions in young patients after orthodontic care.
Read the detailed description
White spot lesions (WSLs) are early signs of tooth decay that appear as milky white spots on tooth enamel, especially common after wearing braces. These lesions can last for many years and negatively affect appearance, especially on front teeth. This study investigates two promising treatment options to reverse or reduce the appearance of WSLs.
Study Design This is a randomized, split-mouth, double-blinded clinical trial conducted at the Operative Dentistry Department, Faculty of Dentistry, Ain Shams University. The trial includes patients between the ages of 15 and 25 with visible white spot lesions on both sides of their front teeth (ICDAS scores 1-2).
Each patient will receive:
SAP P11-4 (Curodont Repair) on one side of the mouth.
CPP-ACP (MI Varnish) on the other side.
The split-mouth design helps reduce differences between participants and improves the reliability of the results.
Intervention Procedure
Participants will undergo:
Initial oral hygiene instructions and professional cleaning.
Standardized digital and cross-polarized photography of the teeth.
Treatment application according to manufacturer instructions:
SAP P11-4 is applied twice (at baseline and 3 months), after cleaning and etching the enamel surface.
CPP-ACP is also applied twice (at baseline and 3 or 6 months), with post-application care instructions (avoid brushing or eating for 4 hours).
Outcome Measures Primary outcome: Change in color of the white spot lesions over 9 months, measured using digital photography and color analysis software (eLAB-prime).
Secondary outcomes:
Change in lesion size.
Visual scoring using the ICDAS II system.
Patient satisfaction with the treatment results, collected through a questionnaire.
The study aims to determine which treatment is more effective at improving the appearance and reducing the visibility of WSLs, with the goal of guiding future esthetic dental care.
- Being tested
- Self-Assembling Peptide P11-4 Self-Assembling Peptide P11-4 is a biomimetic material applied topically to white spot lesions on the enamel. It diffuses into the lesion body and forms a three-dimension
- Keywords
- White Spot Lesions - Enamel Demineralization - Self-Assembling Peptides - Casein Phosphopeptide-Amorphous Calcium Phosphate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Assembling Peptide P11-4 Self-Assembling Peptide P11-4 is a biomimetic material applied topically to white spot lesions on the enamel. It diffuses into the lesion body and forms a three-dimensionOther
Intervention: Self-Assembling Peptide P11-4
Intervention Description:
Self-Assembling Peptide P11-4 (SAP P11-4) is a synthetic peptide designed to mimic natural enamel matrix proteins. It is applied to cleaned, etched enamel surfaces with white spot lesions. The peptide diffuses into the subsurface lesion and self-assembles into a 3D scaffold that promotes nucleation and growth of hydroxyapatite crystals. In this study, it is applied at baseline and re-applied after 3 months. The product used is Curodont™ Repair.
Intervention: Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP)
Intervention Description:
CPP-ACP is a milk-derived peptide complex that stabilizes calcium and phosphate ions in an amorphous form. When applied to enamel surfaces, it delivers these ions to promote remineralization of white spot lesions. In this study, MI Varnish™ is used as the source of CPP-ACP. The varnish is stirred and applied as a thin, uniform layer to cleaned tooth surfaces at baseline and
| Study group | Role | What they receive |
|---|---|---|
| Arm 2 Title: CPP-ACP Treatment | Active comparator | . Arm 2 (CPP-ACP Treatment) - Description: Participants receive Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP) (MI Varnish™) applied to white spot lesions on the opposite side of the anterior teeth. The varnish is applied at baseline and again after 3 or 6 months, according to manufacturer guidelines. Receives: Other: Self-Assembling Peptide P11-4 Self-Assembling Peptide P11-4 is a biomimetic material applied topically to white spot lesions on the enamel. It diffuses into the lesion body and forms a three-dimension |
| Arm 1 Title: SAP P11-4 Treatment | Active comparator | Participants receive Self-Assembling Peptides (SAP P11-4), a biomimetic agent that penetrates enamel white spot lesions and promotes remineralization by forming a 3D peptide scaffold within the lesion. The material is applied to white spot lesions on one side of the anterior teeth at baseline and again after 3 months, following manufacturer instructions. Receives: Other: Self-Assembling Peptide P11-4 Self-Assembling Peptide P11-4 is a biomimetic material applied topically to white spot lesions on the enamel. It diffuses into the lesion body and forms a three-dimension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in white spot lesion color using standardized cross-polarized photography and digital color analysis
The primary outcome is the change in the color of enamel white spot lesions, assessed through standardized digital photographs taken at baseline and at 3, 6, and 9 months. Images will be analyzed using eLAB-prime software for objective color quantification.
Measured: Baseline, 3 months, 6 months, and 9 months
Secondary outcomes (1)
Change in lesion size of white spot lesions based on standardized clinical photographs
Lesion size will be evaluated using standardized digital photographs taken at baseline and at 3, 6, and 9 months. Photographs will be used to measure lesion dimensions and determine any reduction or progression in size over time.
Measured: Baseline, 3 months, 6 months, and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start27 Mar 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries Tooth DemineralizationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a split-mouth, double-blinded, randomized controlled trial using a crossover assignment model. Each participant receives both interventions - Self-Assembling Peptides (SAP P11-4) on one side of the anterior teeth and Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP) on the opposite side. This design minimizes inter-subject variability and allows within-subject comparison of treatment outcomes.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146464
- Sponsor's protocol ID
- opd 22 23 (d)
- Status last verified
- Aug 2025
- First submitted
- 21 Aug 2025
- Last updated
- 10 Sep 2025
- 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 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Self Assembling Peptides Versus Amorphous Calcium Phosphate in the Treatment of White Spot Lesions; Split Mouth Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07146464
- Acronym / sponsor ID
- opd 22 23 (d)
- Keywords
- White Spot Lesions - Enamel Demineralization - Self-Assembling Peptides - Casein Phosphopeptide-Amorphous Calcium Phosphate
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 28 Aug 2025 (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.
This clinical trial aims to compare the effectiveness of two remineralizing treatments for white spot lesions (WSLs) on the enamel surfaces of the front teeth. WSLs are early signs of tooth decay, often appearing after orthodontic treatment with braces. These white spots may persist for years and affect the esthetic appearance of teeth.
The study will include male and female patients aged 15 to 25 who have at least one early carious lesion (ICDAS scores 1 or 2) on each side of their upper or lower front teeth. The purpose is to determine which treatment - Self-Assembling Peptides (SAP P11-4, Curodont Repair™) or Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP, MI Varnish™) - is more effective in improving the color and reducing the size of these lesions.
Researchers will use a split-mouth design, where each patient receives both treatments - one on each side of the mouth. Standardized digital photographs will be taken before and after treatment to assess color changes and lesion size. Patients will also rate their satisfaction with the appearance of their teeth after treatment.
The main questions the study will answer are:
Does SAP P11-4 improve the color of white spot lesions more effectively than CPP-ACP?
Is there a noticeable difference in lesion size reduction between the two treatments?
How satisfied are patients with the outcomes of each treatment?
Participants will be followed up at 3, 6, and 9 months after treatment. The results aim to guide clinicians toward the most effective treatment to improve the appearance of white spot lesions in young patients after orthodontic care.
Detailed description
White spot lesions (WSLs) are early signs of tooth decay that appear as milky white spots on tooth enamel, especially common after wearing braces. These lesions can last for many years and negatively affect appearance, especially on front teeth. This study investigates two promising treatment options to reverse or reduce the appearance of WSLs.
Study Design This is a randomized, split-mouth, double-blinded clinical trial conducted at the Operative Dentistry Department, Faculty of Dentistry, Ain Shams University. The trial includes patients between the ages of 15 and 25 with visible white spot lesions on both sides of their front teeth (ICDAS scores 1-2).
Each patient will receive:
SAP P11-4 (Curodont Repair) on one side of the mouth.
CPP-ACP (MI Varnish) on the other side.
The split-mouth design helps reduce differences between participants and improves the reliability of the results.
Intervention Procedure
Participants will undergo:
Initial oral hygiene instructions and professional cleaning.
Standardized digital and cross-polarized photography of the teeth.
Treatment application according to manufacturer instructions:
SAP P11-4 is applied twice (at baseline and 3 months), after cleaning and etching the enamel surface.
CPP-ACP is also applied twice (at baseline and 3 or 6 months), with post-application care instructions (avoid brushing or eating for 4 hours).
Outcome Measures Primary outcome: Change in color of the white spot lesions over 9 months, measured using digital photography and color analysis software (eLAB-prime).
Secondary outcomes:
Change in lesion size.
Visual scoring using the ICDAS II system.
Patient satisfaction with the treatment results, collected through a questionnaire.
The study aims to determine which treatment is more effective at improving the appearance and reducing the visibility of WSLs, with the goal of guiding future esthetic dental care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a split-mouth, double-blinded, randomized controlled trial using a crossover assignment model. Each participant receives both interventions - Self-Assembling Peptides (SAP P11-4) on one side of the anterior teeth and Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP) on the opposite side. This design minimizes inter-subject variability and allows within-subject comparison of treatment outcomes.
| Arm | Type | Receives |
|---|---|---|
| Arm 2 Title: CPP-ACP Treatment | Active comparator | Other: Self-Assembling Peptide P11-4 Self-Assembling Peptide P11-4 is a biomimetic material applied topically to white spot lesions on the enamel. It diffuses into the lesion body and forms a three-dimension. Arm 2 (CPP-ACP Treatment) - Description: Participants receive Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP) (MI Varnish™) applied to white spot lesions on the opposite side of the anterior teeth. The varnish is applied at baseline and again after 3 or 6 months, according to manufacturer guidelines. |
| Arm 1 Title: SAP P11-4 Treatment | Active comparator | Other: Self-Assembling Peptide P11-4 Self-Assembling Peptide P11-4 is a biomimetic material applied topically to white spot lesions on the enamel. It diffuses into the lesion body and forms a three-dimensionParticipants receive Self-Assembling Peptides (SAP P11-4), a biomimetic agent that penetrates enamel white spot lesions and promotes remineralization by forming a 3D peptide scaffold within the lesion. The material is applied to white spot lesions on one side of the anterior teeth at baseline and again after 3 months, following manufacturer instructions. |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Age between 15 and 25 years
- Presence of at least one tooth on each side of the anterior region (from right canine to left canine) affected by early carious lesions (ICDAS II code 1 or 2)
- Lesion size and form must be fully visible and accessible
- Willing and able to attend all study visits and follow instructions
- Good general health and oral hygiene
Key exclusion criteria (6 listed)
- Evidence of tooth erosion
- Prior fluoride varnish application before study treatment
- Hypoplastic enamel defects or multiple restorations on facial surfaces of anterior teeth
- High caries risk patients
- Known or suspected allergy to milk proteins
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 Peptide P11-4 Self-Assembling Peptide P11-4 is a biomimetic material applied topically to white spot lesions on the enamel. It diffuses into the lesion body and forms a three-dimensionIntervention: Self-Assembling Peptide P11-4 Intervention Description: Self-Assembling Peptide P11-4 (SAP P11-4) is a synthetic peptide designed to mimic natural enamel matrix proteins. It is applied to cleaned, etched enamel surfaces with white spot lesions. The peptide diffuses into the subsurface lesion and self-assembles into a 3D scaffold that promotes nucleation and growth of hydroxyapatite crystals. In this study, it is applied at baseline and re-applied after 3 months. The product used is Curodont™ Repair. Intervention: Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP) Intervention Description: CPP-ACP is a milk-derived peptide complex that stabilizes calcium and phosphate ions in an amorphous form. When applied to enamel surfaces, it delivers these ions to promote remineralization of white spot lesions. In this study, MI Varnish™ is used as the source of CPP-ACP. The varnish is stirred and applied as a thin, uniform layer to cleaned tooth surfaces at baseline and | Other | Arm 1 Title: SAP P11-4 Treatment, Arm 2 Title: CPP-ACP Treatment |
Primary outcome
Change in white spot lesion color using standardized cross-polarized photography and digital color analysis
Time frame: Baseline, 3 months, 6 months, and 9 months
The primary outcome is the change in the color of enamel white spot lesions, assessed through standardized digital photographs taken at baseline and at 3, 6, and 9 months. Images will be analyzed using eLAB-prime software for objective color quantification.
1 secondary outcome
Change in lesion size of white spot lesions based on standardized clinical photographs
Time frame: Baseline, 3 months, 6 months, and 9 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 10 Sep 2025.
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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 study testing Self-Assembling Peptide P11-4 Self-Assembling Peptide P11-4 is a biomimetic material applied topically to white spot lesions on the enamel. It diffuses into the lesion body and forms a three-dimension in people with Dental Caries Tooth Demineralization and Post-Orthodontic Esthetic Defects, run by Ain Shams 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 7 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: looking for participants now, as of the sponsor's last update on 10 Sep 2025. 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?
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 Amany yasser mohamed, B.D.S., M.Sc. (01002229647, amany-mohamed@dent.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in white spot lesion color using standardized cross-polarized photography and digital color analysis (time frame: Baseline, 3 months, 6 months, and 9 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 10 Sep 2025.