Clinical trial NCT03927794: Remineralization of White Spot Lesions Using Self-Assembling Peptide P11-4 in Primary Anterior Teeth A Randomized Clinical Trial
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: White Spot Lesions [Initial Caries] on Smooth Surface of Tooth
Keywords: Self-Assembling Peptide P11-4
Biomimetic Remineralization
White spot lesions
Primary Anterior Teeth
Biomimetic Mineralization
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-04-25
Enrollment: 11
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 Groups where group A will receive self-assembling peptide P11-4 and group B will receive topical fluoride varnish.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Primary anterior teeth in which carious lesions are scored with ICDAS ≥3.
* Subjects on medication that affects the salivary flow rate.

Primary outcomes:
measure: Remineralization of white spot lesions
timeFrame: One year
Secondary outcomes:
measure: Caries progression or regression by ICDAS II system
timeFrame: One year
measure: - Patient satisfaction/dissatisfaction
timeFrame: 1 day
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Ain Shams University
name: Noha SA Kabil, PHD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.