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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05771077
Other study ID # Asmaa Khater
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date June 1, 2022
Est. completion date December 15, 2022

Study information

Verified date March 2023
Source Egymedicalpedia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date December 15, 2022
Est. primary completion date December 1, 2022
Accepts healthy volunteers No
Gender All
Age group 16 Years to 25 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Faculty of Dentistary - Al-Azhar University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Egymedicalpedia

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
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Completed NCT03114475 - Effect of CO2 Laser on Enamel White Spot Lesion Formation Around Orthodontic Brackets N/A
Active, not recruiting NCT06403371 - The Effect of Fluoride Varnish on White Spot Lesion in Clear Aligner Orthodontic Patients N/A
Completed NCT05721586 - Self-assembling Peptide With Sodium Fluoride in Treating White Spot Lesionss in Primary Teeth N/A