Effect of Self Assembling Peptide on White Spot Lesion

White Spot Lesion of Tooth Clinical Trial

— regeneration  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03930927
• Other study ID #: 1998
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: May 1, 2019
• Est. completion date: March 1, 2021

Study information

• Verified date: April 2019
• Source: Cairo University
• Contact: raneen ahmed gohar, Assistant lecturer
• Phone: (002)01007331552
• Email: raneen.aboelgheit[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: March 1, 2021
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 22 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries
• White Spot Lesion of Tooth

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Raneen Ahmed

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remineralizing process	using DIAGNOpen.	6 months
Secondary	Visual assessment	using ICDAS II	6 months