Remineralization of White Spot Lesions Using Self-Assembling Peptide P11-4 in Primary Anterior Teeth A Randomized Clinical Trial
Condition: White Spot Lesions [Initial Caries] on Smooth Surface of Tooth
Study type: Interventional

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.
    

Intervention name(s): Self-Assembling Peptide P11-4
Intervention type(s): Other
Intervention description(s): 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 name(s): Curodont Repair
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 Groups where group A will receive self-assembling peptide P11-4 and group B will receive topical fluoride varnish.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Self-Assembling Peptide P11-4; Biomimetic Remineralization; White spot lesions; Primary Anterior Teeth; Biomimetic Mineralization