White Spot LesionsSAP VS TCPNCT07289932
"Clinical Evaluation of Self-Assembling Peptides Versus Tri-Calcium Phosphate Based Varnish in Treatment of White Spot Lesions; Split-Mouth Randomized Clinical Trial"
A study testing Curodont Repair (SAP P11-4) and Clinpro White Varnish (Tri-Calcium Phosphate, TCP) in people with White Spot Lesions, run by Ain Shams University at 1 site in Egypt.
Trial summary
Brief Summary: This randomized controlled clinical trial will evaluate the effectiveness of two remineralizing agents in the treatment of white spot lesions (WSLs) in young adults. White spot lesions are early signs of enamel demineralization that commonly develop after orthodontic treatment. Read more about this study
- Who is it for?
- Ages 15 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesions
- What is being tested?
- Curodont Repair (SAP P11-4) and Clinpro White Varnish (Tri-Calcium Phosphate, TCP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2024to Dec 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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- A minimum of one tooth affected by early carious lesions (ICDAS-II codes 1 or 2) in both sides of the mouth that do not require invasive treatment.
- Age 15 years and ≤ 25 years
- Size and form of the carious lesions must both be fully visible, and accessible
- Willing and able to attend the on-study visits and to observe good oral hygiene throughout the study
- Provide written informed consent before participation in the study as subjects were minors, informed consent will provided by the parent and/or legal guardian.
- patients not on medication affecting their salivary flow and medically free (ASA class I).
Who cannot join
- Evidence of tooth erosion.
- any form of fluoride application before the study treatment.
- patients with hypoplastic enamel defects, multiple restorations on the facial surfaces.
- High caries risk patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Brief Summary:
This randomized controlled clinical trial will evaluate the effectiveness of two remineralizing agents in the treatment of white spot lesions (WSLs) in young adults. White spot lesions are early signs of enamel demineralization that commonly develop after orthodontic treatment. The study will compare a self-assembling peptide-based varnish (Curodont Repair, SAP P11-4) with a tri-calcium phosphate-based varnish (Clinpro White Varnish, 3M) using a split-mouth design.
Read more
A total of patients aged 15-25 years with at least one eligible WSL on each side of the anterior teeth will be enrolled. Each patient will receive Curodont Repair on one side and Clinpro White Varnish on the contralateral side. Treatments will be applied at baseline and repeated after 3 months. Lesions will be evaluated using standardized digital photography, ICDAS II scoring, lesion size measurements, and patient satisfaction questionnaires at baseline, 3, 6, and 9 months.
The primary outcome is the change in color of white spot lesions over 9 months. Secondary outcomes include changes in lesion size, ICDAS scores, and patient-reported satisfaction. The study is double-blinded (patients and outcome assessors) and conducted at the Faculty of Dentistry, Ain Shams University.
Read the detailed description
White spot lesions (WSLs) represent the earliest clinically detectable stage of enamel caries and are a common consequence of fixed orthodontic treatment. These lesions are characterized by increased opacity of enamel due to subsurface demineralization. Conventional fluoride-based strategies can promote surface remineralization but often fail to achieve full penetration into the lesion body, limiting complete enamel repair.
Novel biomimetic approaches, such as self-assembling peptides (SAP P11-4), have been developed to address this limitation. SAP molecules can diffuse into the subsurface lesion and form a three-dimensional scaffold that attracts calcium and phosphate ions from saliva, facilitating de novo hydroxyapatite formation and deeper remineralization. In contrast, tri-calcium phosphate (TCP) varnishes provide bioavailable minerals in combination with fluoride to enhance surface remineralization.
Although both strategies show promising laboratory and clinical results, there is limited evidence directly comparing their clinical performance in patients with orthodontically induced WSLs. This study aims to fill that gap by using a split-mouth, randomized controlled design to compare the effectiveness of Curodont Repair (SAP P11-4) and Clinpro White Varnish (TCP) in young adult patients.
The study will focus on the extent of remineralization as assessed by digital imaging and color analysis, supplemented by changes in lesion size and ICDAS II scoring. Patient satisfaction will also be evaluated to capture subjective outcomes of esthetic improvement. Findings from this study are expected to contribute to evidence-based recommendations for minimally invasive management of WSLs.
- Conditions
- White Spot Lesions
- Being tested
- Curodont Repair (SAP P11-4), Clinpro White Varnish (Tri-Calcium Phosphate, TCP)
- Keywords
- White spot lesions Orthodontic white spot lesions Enamel demineralization Enamel remineralization, P11-4 Curodont Repair Tri-calcium phosphate varnish, Biomimetic remineralization Split-mouth randomized controlled tria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curodont Repair (SAP P11-4)Other
Application of Curodont Repair, a self-assembling peptide (P11-4) varnish designed to penetrate subsurface enamel lesions and promote hydroxyapatite formation. The varnish will be applied to eligible white spot lesions on one side of the anterior teeth at baseline and re-applied after 3 months according to manufacturer's instructions."
Clinpro White Varnish (Tri-Calcium Phosphate, TCP)Other
"Application of Clinpro White Varnish containing tri-calcium phosphate and fluoride, designed to deliver bioavailable calcium, phosphate, and fluoride ions to the enamel surface. The varnish will be applied to eligible white spot lesions on the contralateral side of the anterior teeth at baseline and re-applied after 3 months according to manufacturer's instructions."
| Study group | Role | What they receive |
|---|---|---|
| Curodont Repair (Self-Assembling Peptide, SAP P11-4) | Experimental | Application of Curodont Repair varnish to eligible white spot lesions on one side of the mouth at baseline and after 3 months. Receives: Other: Curodont Repair (SAP P11-4) |
| Clinpro White Varnish (Tri-Calcium Phosphate, TCP) | Active comparator | Application of Clinpro White Varnish to eligible white spot lesions on the contralateral side of the mouth at baseline and after 3 months. Receives: Other: Clinpro White Varnish (Tri-Calcium Phosphate, TCP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in color of white spot lesions
"Change in color and appearance of white spot lesions will be assessed using standardized digital intraoral photography and eLAB color analysis system. The color difference (ΔE) values will be calculated to quantify remineralization."
Measured: Baseline, 3 months, 6 months, and 9 months
Secondary outcomes (1)
Change in lesion size
"Lesion size will be measured from standardized digital photographs using ImageJ software to calculate changes in lesion surface area."
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 posted17 Dec 2025
- Study start20 Feb 2024
- Primary completion20 Nov 2024
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for White Spot LesionsStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Crossover
- Model description
- "This is a split-mouth randomized controlled clinical trial. Each participant will receive the self-assembling peptide varnish (Curodont Repair) on one side of the mouth and the tri-calcium phosphate varnish (Clinpro White Varnish) on the contralateral side, allowing within-patient comparison."
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 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
- NCT07289932
- Sponsor's protocol ID
- OPD 22 24 (D)
- Acronym
- SAP VS TCP
- Status last verified
- Oct 2025
- First submitted
- 5 Dec 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Clinical Evaluation of Self-Assembling Peptides Versus Tri-Calcium Phosphate Based Varnish in Treatment of White Spot Lesions; Split-Mouth Randomized Clinical Trial"
- ClinicalTrials.gov ID
- NCT07289932
- Acronym / sponsor ID
- SAP VS TCP / OPD 22 24 (D)
- Conditions
- White Spot Lesions
- Keywords
- White spot lesions Orthodontic white spot lesions Enamel demineralization Enamel remineralization, P11-4 Curodont Repair Tri-calcium phosphate varnish, Biomimetic remineralization Split-mouth randomized controlled tria
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 20 Nov 2024 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Dec 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.
Brief Summary:
This randomized controlled clinical trial will evaluate the effectiveness of two remineralizing agents in the treatment of white spot lesions (WSLs) in young adults. White spot lesions are early signs of enamel demineralization that commonly develop after orthodontic treatment. The study will compare a self-assembling peptide-based varnish (Curodont Repair, SAP P11-4) with a tri-calcium phosphate-based varnish (Clinpro White Varnish, 3M) using a split-mouth design.
A total of patients aged 15-25 years with at least one eligible WSL on each side of the anterior teeth will be enrolled. Each patient will receive Curodont Repair on one side and Clinpro White Varnish on the contralateral side. Treatments will be applied at baseline and repeated after 3 months. Lesions will be evaluated using standardized digital photography, ICDAS II scoring, lesion size measurements, and patient satisfaction questionnaires at baseline, 3, 6, and 9 months.
The primary outcome is the change in color of white spot lesions over 9 months. Secondary outcomes include changes in lesion size, ICDAS scores, and patient-reported satisfaction. The study is double-blinded (patients and outcome assessors) and conducted at the Faculty of Dentistry, Ain Shams University.
Detailed description
White spot lesions (WSLs) represent the earliest clinically detectable stage of enamel caries and are a common consequence of fixed orthodontic treatment. These lesions are characterized by increased opacity of enamel due to subsurface demineralization. Conventional fluoride-based strategies can promote surface remineralization but often fail to achieve full penetration into the lesion body, limiting complete enamel repair.
Novel biomimetic approaches, such as self-assembling peptides (SAP P11-4), have been developed to address this limitation. SAP molecules can diffuse into the subsurface lesion and form a three-dimensional scaffold that attracts calcium and phosphate ions from saliva, facilitating de novo hydroxyapatite formation and deeper remineralization. In contrast, tri-calcium phosphate (TCP) varnishes provide bioavailable minerals in combination with fluoride to enhance surface remineralization.
Although both strategies show promising laboratory and clinical results, there is limited evidence directly comparing their clinical performance in patients with orthodontically induced WSLs. This study aims to fill that gap by using a split-mouth, randomized controlled design to compare the effectiveness of Curodont Repair (SAP P11-4) and Clinpro White Varnish (TCP) in young adult patients.
The study will focus on the extent of remineralization as assessed by digital imaging and color analysis, supplemented by changes in lesion size and ICDAS II scoring. Patient satisfaction will also be evaluated to capture subjective outcomes of esthetic improvement. Findings from this study are expected to contribute to evidence-based recommendations for minimally invasive management of WSLs.
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 randomized controlled clinical trial. Each participant will receive the self-assembling peptide varnish (Curodont Repair) on one side of the mouth and the tri-calcium phosphate varnish (Clinpro White Varnish) on the contralateral side, allowing within-patient comparison."
| Arm | Type | Receives |
|---|---|---|
| Curodont Repair (Self-Assembling Peptide, SAP P11-4) | Experimental | Other: Curodont Repair (SAP P11-4)Application of Curodont Repair varnish to eligible white spot lesions on one side of the mouth at baseline and after 3 months. |
| Clinpro White Varnish (Tri-Calcium Phosphate, TCP) | Active comparator | Other: Clinpro White Varnish (Tri-Calcium Phosphate, TCP)Application of Clinpro White Varnish to eligible white spot lesions on the contralateral side of the mouth at baseline and after 3 months. |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- A minimum of one tooth affected by early carious lesions (ICDAS-II codes 1 or 2) in both sides of the mouth that do not require invasive treatment.
- Age 15 years and ≤ 25 years
- Size and form of the carious lesions must both be fully visible, and accessible
- Willing and able to attend the on-study visits and to observe good oral hygiene throughout the study
- Provide written informed consent before participation in the study as subjects were minors, informed consent will provided by the parent and/or legal guardian.
Key exclusion criteria (4 listed)
- Evidence of tooth erosion.
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 (SAP P11-4)Application of Curodont Repair, a self-assembling peptide (P11-4) varnish designed to penetrate subsurface enamel lesions and promote hydroxyapatite formation. The varnish will be applied to eligible white spot lesions on one side of the anterior teeth at baseline and re-applied after 3 months according to manufacturer's instructions." | Other | Curodont Repair (Self-Assembling Peptide, SAP P11-4) |
| Clinpro White Varnish (Tri-Calcium Phosphate, TCP)"Application of Clinpro White Varnish containing tri-calcium phosphate and fluoride, designed to deliver bioavailable calcium, phosphate, and fluoride ions to the enamel surface. The varnish will be applied to eligible white spot lesions on the contralateral side of the anterior teeth at baseline and re-applied after 3 months according to manufacturer's instructions." | Other | Clinpro White Varnish (Tri-Calcium Phosphate, TCP) |
Primary outcome
Change in color of white spot lesions
Time frame: Baseline, 3 months, 6 months, and 9 months
"Change in color and appearance of white spot lesions will be assessed using standardized digital intraoral photography and eLAB color analysis system. The color difference (ΔE) values will be calculated to quantify remineralization."
1 secondary outcome
Change in lesion size
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 17 Dec 2025.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 (SAP P11-4) and Clinpro White Varnish (Tri-Calcium Phosphate, TCP) in people with White Spot Lesions, 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 6 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 17 Dec 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in color of white spot lesions (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 17 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.