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Effect of Self Assembling Peptide on White Spot Lesion (regeneration)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03930927
Recruitment Status : Not yet recruiting
First Posted : April 29, 2019
Last Update Posted : April 29, 2019
Information provided by (Responsible Party):
Raneen Ahmed, Cairo University

Brief Summary:
During re-mineralization of white spot lesion, Will biomimetic self-assembling peptides improve the re-mineralizating effect of the post orthodontic white spot lesion compared to fluoride-based delivery systems?

Condition or disease Intervention/treatment Phase
White Spot Lesion of Tooth Drug: Self Assembling peptide Drug: remineralizing agent Early Phase 1

Detailed Description:

Conservative dentistry no longer prefers the "drill and fill" concept and advocates reversal of lesions via remineralization. . Remineralization is the process of restoring minerals - again, in the form of mineral ions - to the hydroxyapatite latticework structure. It is three-dimensional, and the lost ions must be replaced with ions having the exact same shape, size and the same electrical charge as those lost from the lattice.

Fluoride and self-assembling peptides have been used as adjuncts to enhance remineralization.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of the Re-mineralizing Effect of Biomimetic Self-Assembling Peptides in Post Orthodontic White Spot Lesions Compared to Fluoride-Based Delivery Systems
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes

Arm Intervention/treatment
Experimental: Self Assembling peptide
Drug: Self Assembling peptide
enamel regeneration
Other Name: Curodont

Drug: remineralizing agent
enamel regeneration
Other Name: floride

Experimental: Fluoride
Drug: Self Assembling peptide
enamel regeneration
Other Name: Curodont

Drug: remineralizing agent
enamel regeneration
Other Name: floride

Primary Outcome Measures :
  1. Remineralizing process [ Time Frame: 6 months ]
    using DIAGNOpen.

Secondary Outcome Measures :
  1. Visual assessment [ Time Frame: 6 months ]
    using ICDAS II

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Patients with post orthodontic white spot lesion.
  • Patients with good oral hygiene.
  • Patients with good general health.
  • Cooperative patients.
  • Subjects who signed the informed consent.

Exclusion Criteria:

  • Patients with tetracycline pigmentation and dental fluorosis.
  • Enamel cavitation.
  • Disable patient.
  • patient with any systemic disease or severe medical complications.

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 identifier (NCT number): NCT03930927

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Contact: raneen ahmed gohar, Assistant lecturer (002)01007331552
Contact: sherine hafez ibrahim, Assistant lecturer (002)01099296591

Sponsors and Collaborators
Raneen Ahmed
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Responsible Party: Raneen Ahmed, assistant lecturer, Cairo University Identifier: NCT03930927    
Other Study ID Numbers: 1998
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases