White Spot LesionPhase 1NCT06358066
The Remineralization of Early Enamel Caries in Permanent Teeth
A Phase 1 study testing self assembling peptide p11-4 with fluoride and 5% sodium fluoride varnish in people with White Spot Lesion, run by Tanta University at 1 site in Egypt.
Trial summary
Evaluate clinically the remineralizing potential of self-assembling peptide ( P11-4) fluoride plus in early enamel carious lesions of permanent anterior teeth. Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion
- What is being tested?
- self assembling peptide p11-4 with fluoride and 5% sodium fluoride varnish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Jun 2024to 6 Jan 2025
- Phase
- Phase 1
- 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 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Presence of active non-cavitated carious white spot lesions with DIAGNO/dent reading from 5 to 17 ,on labial surfaces of permanent anterior teeth and International Caries Detection And Assessment System II (ICDAS II) ranging between 1 and 3.
- The children' age range between 10 to14 years old.
- Children had completed fixed orthodontic treatment within the past week.
- Good oral hygiene with a plaque index score 0 or 1.
- No systemic diseases or medication affecting salivary flow.
Who cannot join
- Children with tetracycline pigmentation, dental fluorosis, or enamel hypoplasia.
- Children had fluoride application less than 3 months before the study.
- Presence of restoration and cavitation on the surface to be treated.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Biomimetic Self -Assembling Peptide (p11-4) in The Remineralization of Early Enamel Caries in Permanent Teeth
Evaluate clinically the remineralizing potential of self-assembling peptide ( P11-4) fluoride plus in early enamel carious lesions of permanent anterior teeth.
Read the detailed description
Study design This study will be conducted as a randomized controlled clinical trial. Study setting The study will be carried out in the clinic of Pediatric Dentistry Department, Faculty of Dentistry, Tanta University.
Group assignment:
Fifty children will be randomly allocated using simple random table into two groups as follows:
- Group I (study group): Teeth will be treated with self-assembling peptide (P11-4) fluoride plus varnish.
- Group II (control group): Teeth will be treated with fluoride varnish.
Ethical consideration The purpose of the present study will be explained to both the parents and children and informed consents will be obtained as well as ascents from children .The researcher will be obligated to do dental treatment for every child according to his-her condition as compensation according to the guidelines on human research adopted by the Research Ethics Committee, Faculty of Dentistry, Tanta University.
Materials to be used in the study:
Materials Composition Manufacture Trade names
Fluoride varnish
5% sodium fluoride (22.600ppm) Dentkist-korea Charm varnish R
Self-assembling peptide p11-4 Sodium Fluoride 0.05% Water,Chlorhexidine digluconate,Tromethamine, Trehalose Dihydrate, Oligopeptide-104, HydroxyPropyl MethylCellulose,Citric Acid,Sodium Hydroxide Credentis AG, Windisch, Switzerland CURODONT Repair ™ fluoride plus Polishing paste fluoride free Titanium Oxide Crosstex- Chicago,US Sparkle Free Prophy Paste
Methods
- Clinical examination and assessments:
- Full dental and medical history for the children will be recorded in the child chart.
- Children will be examined under reflector light conditions using sterile mirrors and blunt end probes with compressed air.
- Labial surface of one anterior tooth in each child will be cleaned and plaque debris will be removed using a prophylaxis paste fluoride free and a polishing brush 20,21,.
- Early enamel carious Lesions will be assessed according to the International Caries Detection and Assessment System (ICDAS II; ranging between 1-3) and Laser fluorescence (LF) measurements DIAGNOdent* will be conducted and values will be recorded as baseline data22,23.
- Clinical procedure:
- The selected teeth will be isolated with rubber dam.
- The labile surface of the teeth will be gently cleaned and dried with air syringe.
- In Group I: Self-assembling peptide (P11-4) fluoride plus will be applied according to the manufacturer's instructions by pushing the two cylinders together and will left for 5 min till the tooth surface appears dry to insure its diffusion 15.
- In Group II: Fluoride varnish will be applied under manufacturer instructions by applying thin layer of varnish with a brush in strokes 24. In all groups children will be advised to:
- Not to rinse his or her mouth, eat, or drink for at least 30 minutes after the treatment, only soft food and drink can be consumed in the day of treatment 22.
- The children use a soft toothbrush and fluoridated toothpaste as an oral hygiene regimen23.
- Evaluation:
The remineralizing process of the early enamel carious lesions will be assessed qualitatively using ICDAS II scoring system (table 1) and quantitatively using the laser fluorescence DIAGNOdent measuring at baseline 1, 3, 6 months post-treatment
- Conditions
- White Spot Lesion
- Being tested
- self assembling peptide p11-4 with fluoride, 5% sodium fluoride varnish
- Keywords
- Remineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self assembling peptide p11-4 with fluorideDrug
Also called curodont repair fluoride plus varnish
Self-assembling peptide (P11-4) fluoride plus will be applied according to the manufacturer's instructions by pushing the two cylinders together and will left for 5 min till the tooth surface appears dry to insure its diffusion
The remineralizing process of the early enamel carious lesions will be assessed quantitatively using the laser fluorescence DIAGNOdent measuring and assessed qualitatively using ICDAS II scoring system at baseline 1, 3, 6 months post-treatment
5% sodium fluoride varnishDrug
Also called charm fluoride varnish
Fluoride varnish will be applied under manufacturer instructions by applying thin layer of varnish with a brush in strokes The remineralizing process of the early enamel carious lesions will be assessed quantitatively using the laser fluorescence DIAGNOdent measuring and assessed qualitatively using ICDAS II scoring system at baseline 1, 3, 6 months post-treatment
| Study group | Role | What they receive |
|---|---|---|
| curodont repair fluoride plus | Experimental | Group I (study group): Teeth will be treated with self-assembling peptide (P11-4) fluoride plus varnish. Receives: Drug: self assembling peptide p11-4 with fluoride |
| fluoride varnish | Active comparator | Group II (control group): Teeth will be treated with fluoride varnish. Receives: Drug: 5% sodium fluoride varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remineralization potential
T0:baseline assessment --> T1:1 month(Application of Curodont repair flouride plus /fluoride varnish andAssessment of white spot lesion regression)--> T2: 3 months Assessment of white spot lesion regression__>T3: 6 months assessment of white spot lesion regression by: Inspection under magnification ICDAS II Score 0:Sound tooth surface:
- First visual change in enamel.
- Distinct visual change in enamel visible when wet, lesion must be visible when dry. by:Diagnodent
Measured: 1 month
Secondary outcomes (1)
Remineralization potential
[ Time Frame: T0:baseline assessment -->T1:1 month (Assessment of white spot lesion regression)--> T2:3 months(Application of Curodont repair flouride plus /fluoride varnish and Assessment of white spot lesion regression)--> T3: 6 months( Assessment of white spot lesion regression by Diagnodent , ICDASII
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start6 Jun 2024 (estimated)
- Primary completion6 Nov 2024 (estimated)
- Study completion6 Jan 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.
- More trials run by Tanta 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Ahmed Fathy Mohamed, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06358066
- Sponsor's protocol ID
- self assembling peptides
- Status last verified
- May 2024
- First submitted
- 29 Mar 2024
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Biomimetic Self -Assembling Peptide (p11-4) in The Remineralization of Early Enamel Caries in Permanent Teeth
- ClinicalTrials.gov ID
- NCT06358066
- Acronym / sponsor ID
- self assembling peptides
- Conditions
- White Spot Lesion
- Keywords
- Remineralization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 6 Jun 2024 (estimated)
- Primary completion
- 6 Nov 2024 (estimated)
- Study completion
- 6 Jan 2025 (estimated)
- First posted
- 10 Apr 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.
Evaluate clinically the remineralizing potential of self-assembling peptide ( P11-4) fluoride plus in early enamel carious lesions of permanent anterior teeth.
Detailed description
Study design This study will be conducted as a randomized controlled clinical trial. Study setting The study will be carried out in the clinic of Pediatric Dentistry Department, Faculty of Dentistry, Tanta University.
Group assignment:
Fifty children will be randomly allocated using simple random table into two groups as follows:
- Group I (study group): Teeth will be treated with self-assembling peptide (P11-4) fluoride plus varnish.
- Group II (control group): Teeth will be treated with fluoride varnish.
Ethical consideration The purpose of the present study will be explained to both the parents and children and informed consents will be obtained as well as ascents from children .The researcher will be obligated to do dental treatment for every child according to his-her condition as compensation according to the guidelines on human research adopted by the Research Ethics Committee, Faculty of Dentistry, Tanta University.
Materials to be used in the study:
Materials Composition Manufacture Trade names
Fluoride varnish
5% sodium fluoride (22.600ppm) Dentkist-korea Charm varnish R
Self-assembling peptide p11-4 Sodium Fluoride 0.05% Water,Chlorhexidine digluconate,Tromethamine, Trehalose Dihydrate, Oligopeptide-104, HydroxyPropyl MethylCellulose,Citric Acid,Sodium Hydroxide Credentis AG, Windisch, Switzerland CURODONT Repair ™ fluoride plus Polishing paste fluoride free Titanium Oxide Crosstex- Chicago,US Sparkle Free Prophy Paste
Methods
- Clinical examination and assessments:
- Full dental and medical history for the children will be recorded in the child chart.
- Children will be examined under reflector light conditions using sterile mirrors and blunt end probes with compressed air.
- Labial surface of one anterior tooth in each child will be cleaned and plaque debris will be removed using a prophylaxis paste fluoride free and a polishing brush 20,21,.
- Early enamel carious Lesions will be assessed according to the International Caries Detection and Assessment System (ICDAS II; ranging between 1-3) and Laser fluorescence (LF) measurements DIAGNOdent* will be conducted and values will be recorded as baseline data22,23.
- Clinical procedure:
- The selected teeth will be isolated with rubber dam.
- The labile surface of the teeth will be gently cleaned and dried with air syringe.
- In Group I: Self-assembling peptide (P11-4) fluoride plus will be applied according to the manufacturer's instructions by pushing the two cylinders together and will left for 5 min till the tooth surface appears dry to insure its diffusion 15.
- In Group II: Fluoride varnish will be applied under manufacturer instructions by applying thin layer of varnish with a brush in strokes 24. In all groups children will be advised to:
- Not to rinse his or her mouth, eat, or drink for at least 30 minutes after the treatment, only soft food and drink can be consumed in the day of treatment 22.
- The children use a soft toothbrush and fluoridated toothpaste as an oral hygiene regimen23.
- Evaluation:
The remineralizing process of the early enamel carious lesions will be assessed qualitatively using ICDAS II scoring system (table 1) and quantitatively using the laser fluorescence DIAGNOdent measuring at baseline 1, 3, 6 months post-treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| curodont repair fluoride plus | Experimental | Drug: self assembling peptide p11-4 with fluorideGroup I (study group): Teeth will be treated with self-assembling peptide (P11-4) fluoride plus varnish. |
| fluoride varnish | Active comparator | Drug: 5% sodium fluoride varnishGroup II (control group): Teeth will be treated with fluoride varnish. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Presence of active non-cavitated carious white spot lesions with DIAGNO/dent reading from 5 to 17 ,on labial surfaces of permanent anterior teeth and International Caries Detection And Assessment System II (ICDAS II) ranging between 1 and 3.
- The children' age range between 10 to14 years old.
- Children had completed fixed orthodontic treatment within the past week.
- Good oral hygiene with a plaque index score 0 or 1.
- No systemic diseases or medication affecting salivary flow.
Key exclusion criteria (3 listed)
- Children with tetracycline pigmentation, dental fluorosis, or enamel hypoplasia.
- Children had fluoride application less than 3 months before the study.
- Presence of restoration and cavitation on the surface to be treated.
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 with fluorideAlso: curodont repair fluoride plus varnishSelf-assembling peptide (P11-4) fluoride plus will be applied according to the manufacturer's instructions by pushing the two cylinders together and will left for 5 min till the tooth surface appears dry to insure its diffusion The remineralizing process of the early enamel carious lesions will be assessed quantitatively using the laser fluorescence DIAGNOdent measuring and assessed qualitatively using ICDAS II scoring system at baseline 1, 3, 6 months post-treatment | Drug | curodont repair fluoride plus |
| 5% sodium fluoride varnishAlso: charm fluoride varnishFluoride varnish will be applied under manufacturer instructions by applying thin layer of varnish with a brush in strokes The remineralizing process of the early enamel carious lesions will be assessed quantitatively using the laser fluorescence DIAGNOdent measuring and assessed qualitatively using ICDAS II scoring system at baseline 1, 3, 6 months post-treatment | Drug | fluoride varnish |
Primary outcome
Remineralization potential
Time frame: 1 month
T0:baseline assessment --> T1:1 month(Application of Curodont repair flouride plus /fluoride varnish andAssessment of white spot lesion regression)--> T2: 3 months Assessment of white spot lesion regression__>T3: 6 months assessment of white spot lesion regression by: Inspection under magnification ICDAS II Score 0:Sound tooth surface: 1. First visual change in enamel. 2. Distinct visual change in enamel visible when wet, lesion must be visible when dry. by:Diagnodent
1 secondary outcome
Remineralization potential
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing self assembling peptide p11-4 with fluoride and 5% sodium fluoride varnish in people with White Spot Lesion, run by Tanta 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: status not confirmed, as of the sponsor's last update on 23 May 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Sara Elgebaly, master (01023306741, sarah.elgebaly276@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remineralization potential (time frame: 1 month). 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 23 May 2024.