Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-02-24 @ 2:06 PM
Study NCT ID:
NCT03927794
Status:
COMPLETED
Last Update Posted:
2021-12-15
First Post:
2019-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Remineralization of White Spot Lesions Using Self-Assembling Peptide P11-4 in Primary Anterior Teeth A Randomized Clinical Trial
Sponsor:
Ain Shams University
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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).
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: