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Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
219 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

Effect of Self Assembling Peptide on White Spot Lesion

Clinicaltrials.gov identifier NCT03930927

Recruitment Status Not yet recruiting

First Posted April 29, 2019

Last update posted April 29, 2019

Study Description

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:White Spot Lesion of Tooth
  • Intervention/Treatment: Drug: Self Assembling peptide
    Drug: remineralizing agent
  • Phase: 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.

Study Design
  • Study Type: Interventional
  • 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 2019
  • Estimated Primary Completion Date: October 2020
  • Estimated Study Completion Date: March 2021
Arms and interventions
Arm Intervention/treatment
Experimental: Fluoride
Drug: Self Assembling peptide
enamel regeneration

Drug: remineralizing agent
enamel regeneration
Experimental: Self Assembling peptide
Drug: Self Assembling peptide
enamel regeneration

Drug: remineralizing agent
enamel regeneration
Outcome Measures
  • 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
Eligibility Criteria
  • Ages Eligible for Study: 12 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.

Contacts and Locations

Contact: raneen ahmed gohar, Assistant lecturer (002)01007331552 raneen.aboelgheit@dentistry.cu.edu.eg

Contact: sherine hafez ibrahim, Assistant lecturer (002)01099296591 shereen.hafez@dentistry.cu.edu.eg

Sponsors and Collaborators

Raneen Ahmed

More Information
  • Responsible Party: Raneen Ahmed
  • ClinicalTrials.gov Identifier: NCT03930927 History of Changes
  • 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
  • Plan to Share IPD: Undecided
  • 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.: Yes
  • Additional relevant MeSH terms: Dental Caries