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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

Biomimetic Remineralization Using Self-Assembling Peptide P11-4 in the Prevention and Treatment of Early Carious Lesions in Primary Anterior Teeth

Clinicaltrials.gov identifier NCT03927794

Recruitment Status Recruiting

First Posted April 25, 2019

Last update posted July 9, 2020

Study Description

Brief summary:

This study is a single blinded randomized controlled clinical trial on primary anterior teeth of 3-5 year-old patients suffering from 1 or more white spot lesions Class V (ICDAS system II scores 1-2). 48 teeth will be divided into two groups where Group 1 (24 teeth) will receive Self-Assembling Peptide P11-4 at Day 0 and 12 of these will get a re-application at Day 90. Group 2 (24 teeth) will receive Topical Fluoride Varnish Application (Duraphat) at Day 0 and 12 of these will get a re-application at Day 90. Assessment will be done at baseline using the ICDAS II and Light Induced Fluorescence using Soprolife Camera and then after 1 week of the 1st application, at Day 90, Day 180, Day 270 and Day 365. The assessment of the baseline and follow up data will be performed by the main investigator and two blind investigators to avoid bias.

  • Condition or Disease:White Spot Lesion
  • Intervention/Treatment: Other: Self-Assembling Peptide P11-4
  • Phase: N/A
Detailed Description

Patients aged 3-5 years with 48 teeth affected by white spot lesions (WSL) Class V on their primary anterior teeth (ICDAS 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 with Saliva of normal flow rates (30-60sec) and with healthy saliva pH 5.0-5.8. 1. All participating patients' parents will sign an informed consent. 2. Patients will receive oral health education on how to maintain a proper oral hygiene and proper diet consumption. 3. Unstimulated Salivary flow test, salivary pH testing will be done to decide whether to include or to exclude the patient according to his/her salivary flow rate. 4. 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 1: Self Assembling Peptides P11-4 (Regenamel) 1. 24 teeth will receive treatment by self-assembling peptides P11-4 at Day 0 and will be followed up after 3 months using the above-mentioned measurements. 2. 12 teeth (50%) will receive re-application at Day 90 and the other 12 teeth (50%) won't. Follow up will be done every 3 months for 12 months. Group 2: Topical Fluoride Varnish (Duraphat) 1. 24 teeth will receive treatment by topical fluoride varnish at Day 0 and will be followed up after 3 months using the above-mentioned measurements. 2. 12 teeth (50%) will receive re-application at Day 90 and the other 12 teeth (50%) won't. Follow up will be done every 3 months for 12 months. The assessment of the baseline and follow up data will be performed by the main investigator and two blind investigators to avoid bias. Assessment will be done at baseline using the ICDAS II and Light Induced Fluorescence using Soprolife Camera and then after 1 week of the 1st application, at Day 90, Day 180, Day 270 and Day 365.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 20 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: 2 Groups where group 1 will receive self-assembling peptide and group 2 will receive topical fluoride varnish
  • Masking: Single (Participant)
  • Primary Purpose: Treatment
  • 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
  • Actual Study Start Date: January 2019
  • Estimated Primary Completion Date: November 2020
  • Estimated Study Completion Date: January 2021
Arms and interventions
Arm Intervention/treatment
Active Comparator: Fluoride Varnish
24 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 Camera. Then they will receive Topical Fluoride Varnish at Day 0. 12 teeth will receive a re-application at Day 180 and re-assessment will be done.
Other: Self-Assembling Peptide P11-4
Self-Assembling Peptide P11-4 promotes in depth biomimetic remineralization of hard tissue. 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. 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.
Experimental: Self-Assembling Peptide P11-4
24 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 Camera. Then they will receive Self-Assembling Peptide P11-4 at Day 0. 12 teeth will receive a re-application at Day 180 and re-assessment will be done.
Other: Self-Assembling Peptide P11-4
Self-Assembling Peptide P11-4 promotes in depth biomimetic remineralization of hard tissue. 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. 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.
Outcome Measures
  • Primary Outcome Measures: 1. Remineralization of white spot lesions [ Time Frame: 6 months- 1 year ]
    Remineralizing efficacy of self-assembling peptide P11-4 versus fluoride varnish using light induced fluorescence (Soprolife Camera). Patients' white spot lesions class V will be examined using Soprolife camera to identify the demineralized areas. At 1 week, 3 months intervals after treatment their lesions will be re-assessed and compared with baseline data. No. of lesions that increase in size or decrease will be counted and analyzed.
  • Secondary Outcome Measures: 1. Caries progression or regression by ICDAS II system [ Time Frame: 1 year ]
    Caries progression/ regression using ICDAS II system. If the score has increased to ICDAS 3 or more indicates caries progression and if it decreases to 0-1 this indicates caries regression; if score remains the same this indicates no change in lesion. Each lesion will be scored at baseline by ICDAS II system and then at 3 months intervals for 1 year. No. of lesions with scores 0,1,2,3 or more will be assessed and analyzed.
  • 2. - Patient satisfaction/dissatisfaction [ Time Frame: 1 week ]
    - Patient satisfaction/dissatisfaction regarding each intervention using a simple questionnaire for each patient undergoing the treatment. This will be done within the 1st week after treatment.
Eligibility Criteria
  • Ages Eligible for Study: 3 to 5 Years (Child)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

Inclusion Criteria:

- ≥1 Primary Anterior Teeth with early carious lesion (Class V) of ICDAS scores 1-2.

- Subjects whose parents are willing and able to maintain good oral hygiene for their
children and attend study visits.

- Subjects with Saliva of normal flow rates (30-60sec) and with healthy saliva pH
6.75-7.25.

- Patients aged between 3-5 years.

- Subjects with a minimum of 1 and a maximum of 12 primary anterior teeth with early
carious lesions Class V of ICDAS score 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.

- Subjects with evidence of reduced salivary flow (>60 sec) or with acidic saliva
pH˂5.8.

Contacts and Locations
Contacts

Contact: Nour Wahba, MSC +201222124096 Nourwahba@gmail.com

Contact: Gehan GA Allam, PHD +201223793534 gigimm14@yahoo.com

Locations

Egypt
Ain Shams University
Cairo

Sponsors and Collaborators

Ain Shams University

Investigators

Study Director: Noha SA Kabil, PHD Ain Shams University