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

Evaluation of the Re-mineralizing Effect of Biomimetic Self-Assembling Peptides in Post Orthodontic White Spot Lesions Compared to Fluoride-Based Delivery Systems

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?

Study Overview

• Status: Unknown
• Conditions: White Spot Lesion of Tooth
• Intervention / Treatment: Drug: Self Assembling peptide; Drug: remineralizing agent

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 Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Early Phase 1

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 22 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self Assembling peptide; intervention	Drug: Self Assembling peptide; enamel regeneration; Other Names: Curodont; Drug: remineralizing agent; enamel regeneration; Other Names: floride
Experimental: Fluoride; Comparator	Drug: Self Assembling peptide; enamel regeneration; Other Names: Curodont; Drug: remineralizing agent; enamel regeneration; Other Names: floride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remineralizing process	using DIAGNOpen.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual assessment	using ICDAS II	6 months

Collaborators and Investigators

• Sponsor: Raneen Ahmed

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2019
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: April 19, 2019
• First Submitted That Met QC Criteria: April 25, 2019
• First Posted (Actual): April 29, 2019

Study Record Updates

• Last Update Posted (Actual): April 29, 2019
• Last Update Submitted That Met QC Criteria: April 25, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 1998

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• 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