Remineralization of White Spot Lesions Using Self-Assembling Peptide P11-4 in Primary Anterior Teeth A Randomized Clinical Trial

NCT03927794 | Completed

• 1 other identifier: PED 19-1 D
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  One year

Secondary Outcomes (2)

• Caries progression or regression by ICDAS II system

  One year

• - Patient satisfaction/dissatisfaction

  1 day

Study Arms (2)

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.

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.

Other: Self-Assembling Peptide P11-4

Interventions

Self-Assembling Peptide P11-4 OTHER

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.

Also known as: Curodont Repair

5% Fluoride Varnish; Self-Assembling Peptide P11-4

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11353, Egypt

Location

Related Publications (4)

• 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.

  PMID: 29355413 RESULT

• 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.

  PMID: 28892645 RESULT

• 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.

  PMID: 28346861 RESULT

• 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.

  PMID: 28052551 RESULT

Study Officials

• Noha SA Kabil, PHD

  Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double blinded trial where patients won't know to which group they are assigned and where the outcome assessor will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Model Details: 2 Groups where group A will receive self-assembling peptide P11-4 and group B will receive topical fluoride varnish.

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: April 25, 2019
• Study Start: September 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: December 15, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)