Remineralization of White Spot Lesions Using Self-Assembling Peptide P11-4 in Primary Anterior Teeth A Randomized Clinical Trial
NCT ID: NCT03927794
Last Updated: 2021-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
11 participants
INTERVENTIONAL
2020-09-01
2021-09-01
Brief Summary
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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
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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).
1. All participating patients' parents will sign an informed consent.
2. Patients will receive oral information on oral health education on how to maintain a proper oral hygiene and proper diet consumption.
3. 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.
5\) Every patient will receive prophylaxis (polishing) using non-fluoridated prophylaxis paste prior to the commencement of treatment to avoid possible confounding factors.
6\) 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)
1\) 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Self-Assembling Peptide P11-4
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.
Self-Assembling Peptide P11-4
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.
5% Fluoride Varnish
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.
Self-Assembling Peptide P11-4
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.
Interventions
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Self-Assembling Peptide P11-4
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ≥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.
Exclusion Criteria
* Subjects on medication that affects the salivary flow rate.
3 Years
5 Years
ALL
Yes
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Nour Wahba
Assistant Lecturer
Principal Investigators
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Noha SA Kabil, PHD
Role: STUDY_DIRECTOR
Ain Shams University
Locations
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Ain Shams University
Cairo, , Egypt
Countries
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References
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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.
Alkilzy 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.
Kind 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.
Silvertown 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.
Other Identifiers
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PED 19-1 D
Identifier Type: -
Identifier Source: org_study_id