White Spot Lesions [Initial Caries] on Smooth Surface of ToothNCT03927794
Remineralization of White Spot Lesions Using Self-Assembling Peptide P11-4 in Primary Anterior Teeth A Randomized Clinical Trial
A study testing Self-Assembling Peptide P11-4 in people with White Spot Lesions [Initial Caries] on Smooth Surface of Tooth, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study is a randomized controlled clinical trial on primary anterior teeth of 3-5 year-old patients suffering from white spot lesions (ICDAS system II scores 1-2). Forty four teeth will be divided into two groups where Group 1 (n=22 teeth) will receive Self-Assembling Peptide P11-4. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesions [Initial Caries] on Smooth Surface of Tooth
- What is being tested?
- Self-Assembling Peptide P11-4
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 1 Sep 2021
- 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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy patients ASA Class I.
- ≥1 Primary Anterior Teeth with early carious lesions of ICDAS scores 1-2.
- Subjects whose parents are willing and able to maintain good oral hygiene for their children and attend study visits.
- Patients aged between 3-5 years.
- Subjects with a minimum of 1 and a maximum of 12 primary anterior teeth with early carious lesions of ICDAS II scores 1-2.
Who cannot join
- Primary anterior teeth in which carious lesions are scored with ICDAS ≥3.
- Subjects on medication that affects the salivary flow rate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biomimetic Remineralization Using Self-Assembling Peptide P11-4 in the Prevention and Treatment of Early Carious Lesions in Primary Anterior Teeth: An In-Vivo and In-Vitro Study
This study is a randomized controlled clinical trial on primary anterior teeth of 3-5 year-old patients suffering from white spot lesions (ICDAS system II scores 1-2).
Forty four teeth will be divided into two groups where Group 1 (n=22 teeth) will receive Self-Assembling Peptide P11-4.
Read more
Group 2 (n=22 teeth) will receive Topical Fluoride Varnish Application.
Assessment will be done at baseline using the International Caries Detection and Assessment System II (ICDAS II) scoring system and Light Induced Fluorescence using Soprolife System (Acteon, La Ciotat, France) and then after 3 months, 6 months and 1 year. The assessment of the baseline and follow up data will be performed by the main investigator.
Read the detailed description
Patients aged 3-5 years with 44 teeth affected by white spot lesions (WSL) on their primary anterior teeth (ICDAS II scores 1-2) will be selected by simple random sample.
A minimum of 1 tooth and a maximum of 12 teeth affected by WSL in each patient can be included.
Subjects whose parents are willing and able to maintain good oral hygiene for their children and attend study visits.Subjects not on medication affecting their salivary flow and medically free (ASA class I).
- All participating patients' parents will sign an informed consent.
- Patients will receive oral information on oral health education on how to maintain a proper oral hygiene and proper diet consumption.
- They will be given manual tooth brushes and non-fluoridated tooth pastes to use during the study. The tooth brushes will be replaced every 3 months and the tooth pastes will be replaced whenever they are empty.
- Every patient will receive prophylaxis (polishing) using non-fluoridated prophylaxis paste prior to the commencement of treatment to avoid possible confounding factors.
- Then each patient will be assigned to one of the two groups:
Group A: Self Assembling Peptides P11-4 (SAP Curodont Repair, Credentis, Windisch, Switzerland) 1) Twenty two teeth will receive treatment by self-assembling peptides P11-4 at baseline and will be followed up at 3 months, 6 months and 1 year using the above-mentioned measurements.
Group B: Topical Fluoride Varnish (Duraphat Varnish containing 22,600ppm fluoride, Colgate-Palmolive, USA)
- Twenty two teeth will receive treatment by topical fluoride varnish at Day 0 and will be followed up after 3 months, 6 months and 1 year using the above-mentioned measurements.
The assessment of the baseline and follow up data will be performed by the main investigator.
Assessment will be done at baseline using the ICDAS II and Light Induced Fluorescence using Soprolife System (Acteon, La Ciotat, France) and then at 3 months, 6 months and 1 year.
- Being tested
- Self-Assembling Peptide P11-4
- Keywords
- Self-Assembling Peptide P11-4, Biomimetic Remineralization, White spot lesions, Primary Anterior Teeth, Biomimetic Mineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Assembling Peptide P11-4Other
Also called Curodont Repair
Self-Assembling Peptide P11-4 promotes subsurface biomimetic remineralization of enamel. It is a small peptide comprising 11 amino acids that when applied to an initial carious lesion diffuses into the body of the lesion, re-assembles itself into fibrils forming larger fibers and hence a 3-dimensional (3-D) matrix is formed. Natural remineralization driven by saliva is promoted through the surface of the P11-4 by increasing the surface area for calcium phosphate deposition. As a result, mineralization of the subsurface lesion occurs possibly due to the formation of de novo hydroxyapatite crystals on the surface of the P11-4 fibers.
| Study group | Role | What they receive |
|---|---|---|
| Self-Assembling Peptide P11-4 | Experimental | Twenty two teeth affected with white spot lesions of ICDAS II score 1-2 will be assessed at baseline using ICDAS II Scoring and Light Induced Fluorescence by Soprolife System.
Then they will receive the intervention by the self-Assembling Peptide P11-4 at Day 0 and will be followed up at 3 months, 6 months and 1 year. Receives: Other: Self-Assembling Peptide P11-4 |
| 5% Fluoride Varnish | Active comparator | Twenty two teeth affected with white spot lesions of ICDAS II score 1-2 will be assessed as baseline using ICDAS II Scoring and Light Induced Fluorescence by Soprolife System.
Then they will receive Topical Fluoride Varnish at Day 0 and will be followed up at 3 months, 6 months and 1 year. Receives: Other: Self-Assembling Peptide P11-4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remineralization of white spot lesions
Remineralizing efficacy of self-assembling peptide P11-4 versus fluoride varnish using light induced fluorescence (Soprolife Camera). Patients' white spot lesions will be examined using Soprolife camera to identify the demineralized areas. At 3 months, 6 months, and 1 year after treatment their lesions will be re-assessed and compared with baseline data.
Measured: One year
Secondary outcomes (2)
Caries progression or regression by ICDAS II system
Caries progression/ regression using ICDAS II system. If the score has increased to ICDAS 3 or more indicates caries progression and if it decreases to 0-1 this indicates caries regression; if score remains the same this indicates no change in lesion.
Each lesion will be scored at baseline by ICDAS II system and then at 3 months, 6 months, and 1 year.
Measured: One year
- Patient satisfaction/dissatisfaction
- Patient satisfaction/dissatisfaction regarding each intervention using a Caregiver Satisfaction Questionnaire for each patient undergoing the treatment. This will be done on the same visit of treatment after its application.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start1 Sep 2020
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for White Spot Lesions [Initial Caries] on Smooth Surface of ToothStudies 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
- Parallel groups
- Model description
- 2 Groups where group A will receive self-assembling peptide P11-4 and group B will receive topical fluoride varnish.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nour Wahba, Ain Shams University
- Investigators
- Noha SA Kabil, PHD, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03927794
- Sponsor's protocol ID
- PED 19-1 D
- Status last verified
- Dec 2021
- First submitted
- 22 Apr 2019
- Last updated
- 15 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alkilzy M, Santamaria RM, Schmoeckel J, Splieth CH. Treatment of Carious Lesions Using Self-Assembling Peptides. Adv Dent Res. 2018 Feb;29(1):42-47. doi: 10.1177/0022034517737025.
PubMed 29355413Alkilzy M, Tarabaih A, Santamaria RM, Splieth CH. Self-assembling Peptide P11-4 and Fluoride for Regenerating Enamel. J Dent Res. 2018 Feb;97(2):148-154. doi: 10.1177/0022034517730531. Epub 2017 Sep 11.
PubMed 28892645Kind L, Stevanovic S, Wuttig S, Wimberger S, Hofer J, Muller B, Pieles U. Biomimetic Remineralization of Carious Lesions by Self-Assembling Peptide. J Dent Res. 2017 Jul;96(7):790-797. doi: 10.1177/0022034517698419. Epub 2017 Mar 27.
PubMed 28346861Silvertown JD, Wong BPY, Sivagurunathan KS, Abrams SH, Kirkham J, Amaechi BT. Remineralization of natural early caries lesions in vitro by P11 -4 monitored with photothermal radiometry and luminescence. J Investig Clin Dent. 2017 Nov;8(4). doi: 10.1111/jicd.12257. Epub 2017 Jan 4.
PubMed 28052551
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomimetic Remineralization Using Self-Assembling Peptide P11-4 in the Prevention and Treatment of Early Carious Lesions in Primary Anterior Teeth: An In-Vivo and In-Vitro Study
- ClinicalTrials.gov ID
- NCT03927794
- Acronym / sponsor ID
- PED 19-1 D
- Keywords
- Self-Assembling Peptide P11-4, Biomimetic Remineralization, White spot lesions, Primary Anterior Teeth, Biomimetic Mineralization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 25 Apr 2019 (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 study is a randomized controlled clinical trial on primary anterior teeth of 3-5 year-old patients suffering from white spot lesions (ICDAS system II scores 1-2).
Forty four teeth will be divided into two groups where Group 1 (n=22 teeth) will receive Self-Assembling Peptide P11-4.
Group 2 (n=22 teeth) will receive Topical Fluoride Varnish Application.
Assessment will be done at baseline using the International Caries Detection and Assessment System II (ICDAS II) scoring system and Light Induced Fluorescence using Soprolife System (Acteon, La Ciotat, France) and then after 3 months, 6 months and 1 year. The assessment of the baseline and follow up data will be performed by the main investigator.
Detailed description
Patients aged 3-5 years with 44 teeth affected by white spot lesions (WSL) on their primary anterior teeth (ICDAS II scores 1-2) will be selected by simple random sample.
A minimum of 1 tooth and a maximum of 12 teeth affected by WSL in each patient can be included.
Subjects whose parents are willing and able to maintain good oral hygiene for their children and attend study visits.Subjects not on medication affecting their salivary flow and medically free (ASA class I).
- All participating patients' parents will sign an informed consent.
- Patients will receive oral information on oral health education on how to maintain a proper oral hygiene and proper diet consumption.
- They will be given manual tooth brushes and non-fluoridated tooth pastes to use during the study. The tooth brushes will be replaced every 3 months and the tooth pastes will be replaced whenever they are empty.
- Every patient will receive prophylaxis (polishing) using non-fluoridated prophylaxis paste prior to the commencement of treatment to avoid possible confounding factors.
- Then each patient will be assigned to one of the two groups:
Group A: Self Assembling Peptides P11-4 (SAP Curodont Repair, Credentis, Windisch, Switzerland) 1) Twenty two teeth will receive treatment by self-assembling peptides P11-4 at baseline and will be followed up at 3 months, 6 months and 1 year using the above-mentioned measurements.
Group B: Topical Fluoride Varnish (Duraphat Varnish containing 22,600ppm fluoride, Colgate-Palmolive, USA)
- Twenty two teeth will receive treatment by topical fluoride varnish at Day 0 and will be followed up after 3 months, 6 months and 1 year using the above-mentioned measurements.
The assessment of the baseline and follow up data will be performed by the main investigator.
Assessment will be done at baseline using the ICDAS II and Light Induced Fluorescence using Soprolife System (Acteon, La Ciotat, France) and then at 3 months, 6 months and 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 2 Groups where group A will receive self-assembling peptide P11-4 and group B will receive topical fluoride varnish.
| Arm | Type | Receives |
|---|---|---|
| Self-Assembling Peptide P11-4 | Experimental | Other: Self-Assembling Peptide P11-4Twenty two teeth affected with white spot lesions of ICDAS II score 1-2 will be assessed at baseline using ICDAS II Scoring and Light Induced Fluorescence by Soprolife System. Then they will receive the intervention by the self-Assembling Peptide P11-4 at Day 0 and will be followed up at 3 months, 6 months and 1 year. |
| 5% Fluoride Varnish | Active comparator | Other: Self-Assembling Peptide P11-4Twenty two teeth affected with white spot lesions of ICDAS II score 1-2 will be assessed as baseline using ICDAS II Scoring and Light Induced Fluorescence by Soprolife System. Then they will receive Topical Fluoride Varnish at Day 0 and will be followed up at 3 months, 6 months and 1 year. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy patients ASA Class I.
- ≥1 Primary Anterior Teeth with early carious lesions of ICDAS scores 1-2.
- Subjects whose parents are willing and able to maintain good oral hygiene for their children and attend study visits.
- Patients aged between 3-5 years.
- Subjects with a minimum of 1 and a maximum of 12 primary anterior teeth with early carious lesions of ICDAS II scores 1-2.
Key exclusion criteria (2 listed)
- Primary anterior teeth in which carious lesions are scored with ICDAS ≥3.
- Subjects on medication that affects the salivary flow rate.
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 P11-4Also: Curodont RepairSelf-Assembling Peptide P11-4 promotes subsurface biomimetic remineralization of enamel. It is a small peptide comprising 11 amino acids that when applied to an initial carious lesion diffuses into the body of the lesion, re-assembles itself into fibrils forming larger fibers and hence a 3-dimensional (3-D) matrix is formed. Natural remineralization driven by saliva is promoted through the surface of the P11-4 by increasing the surface area for calcium phosphate deposition. As a result, mineralization of the subsurface lesion occurs possibly due to the formation of de novo hydroxyapatite crystals on the surface of the P11-4 fibers. | Other | 5% Fluoride Varnish, Self-Assembling Peptide P11-4 |
Primary outcome
Remineralization of white spot lesions
Time frame: One year
Remineralizing efficacy of self-assembling peptide P11-4 versus fluoride varnish using light induced fluorescence (Soprolife Camera). Patients' white spot lesions will be examined using Soprolife camera to identify the demineralized areas. At 3 months, 6 months, and 1 year after treatment their lesions will be re-assessed and compared with baseline data.
2 secondary outcomes
Caries progression or regression by ICDAS II system
Time frame: One year
- Patient satisfaction/dissatisfaction
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
- Results publication: PubMed 29355413Alkilzy M, Santamaria RM, Schmoeckel J, Splieth CH. Treatment of Carious Lesions Using Self-Assembling Peptides. Adv Dent Res. 2018 Feb;29(1):42-47. doi: 10.1177/0022034517737025.
- Results publication: PubMed 28892645Alkilzy M, Tarabaih A, Santamaria RM, Splieth CH. Self-assembling Peptide P11-4 and Fluoride for Regenerating Enamel. J Dent Res. 2018 Feb;97(2):148-154. doi: 10.1177/0022034517730531. Epub 2017 Sep 11.
- Results publication: PubMed 28346861Kind L, Stevanovic S, Wuttig S, Wimberger S, Hofer J, Muller B, Pieles U. Biomimetic Remineralization of Carious Lesions by Self-Assembling Peptide. J Dent Res. 2017 Jul;96(7):790-797. doi: 10.1177/0022034517698419. Epub 2017 Mar 27.
- Results publication: PubMed 28052551Silvertown JD, Wong BPY, Sivagurunathan KS, Abrams SH, Kirkham J, Amaechi BT. Remineralization of natural early caries lesions in vitro by P11 -4 monitored with photothermal radiometry and luminescence. J Investig Clin Dent. 2017 Nov;8(4). doi: 10.1111/jicd.12257. Epub 2017 Jan 4.
- Individual participant dataSharing planned: No
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.
Noha SA Kabil, PHD study director
Ain Shams 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 Self-Assembling Peptide P11-4 in people with White Spot Lesions [Initial Caries] on Smooth Surface of Tooth, 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 15 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Remineralization of white spot lesions (time frame: One year). 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 NCT03927794, which also lists 4 linked publications.
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 15 Dec 2021.