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Trial record 83 of 1202 for:    tooth decay

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

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ClinicalTrials.gov Identifier: NCT03927794
Recruitment Status : Recruiting
First Posted : April 25, 2019
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Nour Wahba, Ain Shams University

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 Intervention/treatment Phase
White Spot Lesion Other: Self-Assembling Peptide P11-4 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
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)
Masking Description: Single blinded trial where patients won't know whether they are receiving Self-Assembling Peptide P11-4 or Topical Fluoride Varnish
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 10, 2019
Estimated Primary Completion Date : January 10, 2020
Estimated Study Completion Date : January 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes Tooth Decay

Arm Intervention/treatment
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.
Other Names:
  • Regenamel
  • Curodont

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.
Other Names:
  • Regenamel
  • Curodont




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.



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Ages Eligible for Study:   3 Years 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927794


Contacts
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Contact: Nour Wahba, MSC +201222124096 Nourwahba@gmail.com
Contact: Gehan GA Allam, PHD +201223793534 gigimm14@yahoo.com

Locations
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Egypt
Ain Shams University Recruiting
Cairo, Egypt, 11353
Contact: Nour Wahba, MSC    +201222124096    Nourwahba@gmail.com   
Sponsors and Collaborators
Ain Shams University
Investigators
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Study Director: Noha SA Kabil, PHD Ain Shams University

Publications of Results:
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Responsible Party: Nour Wahba, Assistant Lecturer, Ain Shams University
ClinicalTrials.gov Identifier: NCT03927794     History of Changes
Other Study ID Numbers: PED 19-1 D
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nour Wahba, Ain Shams University:
Self-Assembling Peptide P11-4
Biomimetic Remineralization
White spot lesions
Primary Anterior Teeth
Biomimetic Mineralization

Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides, Topical
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs