Effect of Poly Amido Amine Dendrimer, Nano-hydroxyapatite

The Effect of Poly Amido Amine Dendrimer, Nano-hydroxyapatite and Their Combination on Micro Hardness of Demineralized Enamel and Their Clinical Efficacy in Management of White Spot Lesions

Dental caries is a common oral disease. The process of caries formation is a cycle of remineralization and demineralization with various stages being either reversible or irreversible.

Study Overview

• Status: Completed
• Conditions: White Spot Lesion
• Intervention / Treatment: Drug: Poly(Amidoamine) dendrimer

Detailed Description

White spot lesions (WSLs) are defined as enamel surface and subsurface demineralization, without cavitation. These manifestations represent the first clinical observation of the progression of dental caries, with the possibility of being reversed.

WSLs are characterized by a white, chalky, opaque appearance and are commonly located in pits, fissures, and smooth surfaces of teeth. However, after the placement of fixed orthodontic appliances, there are an increasing number of plaque retention sites due to the presence of brackets, bands, wires and other applications, which make oral hygiene more difficult, and limit naturally occurring self-cleansing mechanisms. As a consequence, there is an increased risk of demineralization and, conclusively, of WSLs forming on smooth surfaces, if there is no effective plaque removal

The clinical characteristics of these lesions include loss of normal translucency of the enamel because of altered light properties with a chalky white appearance, particularly when dehydrated; a fragile surface layer susceptible to damage from probing, particularly in pits and fissures; increased porosity, particularly of the subsurface, with increased potential for uptake of stains; reduced density of the subsurface, which may be detectable radiographically, with transillumination or with modern laser detecting devices; and potential for remineralization, with an increased resistance to further acid challenge particularly with the use of enhanced remineralization treatments.

It is possible to find numerous therapies for WSLs, for instance, hygiene education, fluorides, phosphopeptide compounds, xylitol and infiltrative resins, microabrasion and/or bleaching, and preparation and restoration. The professional application or prescription of fluorides for home use includes: gels, toothpastes, mouthwashes and varnishes. The fluoride ions are revealed in three ways: sodium monofluorophosphate, sodium fluoride and amine fluoride. It has been found that high fluoride concentrations promote WSL remineralization However; it occurs in the enamel surface and inhibits the ions' movement through the subsurface, affecting the subsurface remineralization and therefore, the light reflection

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Dentistary - Al-Azhar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The patients have at least 3 WSLS.
• The patients aged between 16 and 25 years old
• The patients with good general health and no systemic disease.

Exclusion Criteria:

• Presence of enamel hypoplasia or dental fluorosis.
• Presence of carious cavity.
• Allergy to fluoride gel being used in this stufy
• Patients who have a significant medical history, including pregnancy and breast feeding and smokers.
• Patients who have evidence of reduced salivary flow or significant tooth wear.
• Patients who had participating in concurrent clinical trials or who had recently participated in other clinical trials of an investigational drug or device.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients have White spot lesions; White spot lesions (WSLs) are defined as enamel surface and subsurface demineralization, without cavitation. These manifestations represent the first clinical observation of the progression of dental caries, with the possibility of being reversed	Drug: Poly(Amidoamine) dendrimer; to evaluate the Remineralizing effect of Poly Amido Amine Dendrimer, Nanohydroxy apatite & Their Combination on demineralized enamel & Their Clinical Efficacy on White Spot lesion; Other Names: Nano-hydroxyapatite

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remineralization	to evaluate the Remineralizing effect of Poly Amido Amine Dendrimer and Nanohydroxy apatite alone or combined on demineralized enamel on White Spot lesion. Remineralization will be assessed by radiodensity using digital radiography	3 months

Collaborators and Investigators

• Sponsor: Egymedicalpedia
• Investigators: Study Chair: Wael Essam Gamel, Professor, Al-Azhar Faculty of Dentistary for girls

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 15, 2022

Study Registration Dates

• First Submitted: February 23, 2023
• First Submitted That Met QC Criteria: March 4, 2023
• First Posted (Actual): March 16, 2023

Study Record Updates

• Last Update Posted (Actual): March 16, 2023
• Last Update Submitted That Met QC Criteria: March 4, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Asmaa Khater

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No