Viewing Study NCT03217084



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Last Modification Date: 2024-10-26 @ 12:27 PM
Study NCT ID: NCT03217084
Status: UNKNOWN
Last Update Posted: 2018-02-06
First Post: 2017-07-12

Brief Title: Treatment of Postorthodontic White Spot Lesions
Sponsor: Cairo University
Organization: Cairo University

Study Overview

Official Title: Esthetic Effect of Casein Phosphopeptide-Amorphous Calcium Phosphate Varnish Versus Tricalcium Phosphate Varnish on Postorthodontic White Spot Lesions A Randomized Pilot Study
Status: UNKNOWN
Status Verified Date: 2018-02
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Dental caries is the destruction of the tooth structure in the presence of organic acids produced by cariogenic bacteria located in the dental biofilm Dowker et al 1999 and Robinson et al 2000Tooth enamel comprises 90 substituted hydroxyapatite Ca10 PO46OH 2 which is subjected to consecutive cycles of demineralization and remineralization This is an interrupted process with periods of remineralization and demineralization occurring depending on the state of the oral environment in terms of the prolonged accumulation and retention of bacterial plaque on the enamel surface Aoba 2004

Oral bacteria ferment carbohydrates to produce organic acids which lower the pH and cause the subsurface dissolution of the hydroxyapatite crystals Under normal physiological conditions pH7 saliva is supersaturated with calcium and phosphate ions which diffuse into the vacancies created during acid-mediated demineralization episodes Dowker et al 1999 and Robinson et al 2000 The demineralization of enamel white spot lesions is a significant problem during and after orthodontic treatment with prevalence 711 and various preventive measures have been suggested to minimize the incidence Derks et al 2004 and Al Maaitah et al 2011
Detailed Description: In orthodontic patients demineralization usually takes place in the form of white or brown spots on the enamel around the brackets and can lead to cavitation Al Maaitah et al 2011 White spot lesions compromise esthetics and can be extremely difficult or even impossible to reverse

Natural remineralization through saliva involving a mineral gain in the surface layer of white spot lesions has little improvement on the esthetic and structural properties of the deeper lesions Karlinsey et al 2009 and Cochrane et al 2010 Management of white spot lesion should involve methods of both preventing demineralization and encourage the remineralization of existing lesions In both of these processes the efficacy of fluoride is well established Fluoride increases the initial rate of remineralization of early enamel lesions Consequently it slows down the caries process and arresting the lesion Fluoride varnish provides a protective coat over the tooth which adheres longer to the tooth surface Demito et al 2004 and Ten Cate et al 2008

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: True
Is an FDA AA801 Violation?: None