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

Ain Shams University

Status: Completed

Conditions: White Spot Lesions [Initial Caries] on Smooth Surface of Tooth

Treatments: Other: Self-Assembling Peptide P11-4

Study type: Interventional

Funder types: Other

Identifiers

NCT03927794

PED 19-1 D

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 3 to 5 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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11 participants in 2 patient groups

Self-Assembling Peptide P11-4

Experimental group

Description:

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.

Treatment:

Other: Self-Assembling Peptide P11-4

5% Fluoride Varnish

Active Comparator group

Description:

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.

Treatment:

Other: Self-Assembling Peptide P11-4