White spot lesion development in post-orthodontic patients following weekly application of a 1.25% fluoride gel compared to placebo over 6 months

GABA International AG0 个研究点开始时间: 2010年11月10日最近更新: 2015年11月16日

试验速览

暂无简介。

•Written informed consent
•Healthy volunteers (= 11 years) scheduled for bracket removal
•Multibracket appliance therapy in the upper jaw for at least one year
•= 1 WSL with a modified score 1 or 2 (Gorelick et al. 1982) on UFT at debonding
•WSL not present at start of orthodontic treatment (comparison with pre-treatment intraoral photographs).
•No restorative or prosthetic therapy planned on UFT
•Agreement of patient (for the whole study duration) not to use any oral hygiene products other than the ones received in this study (allowed in addition: oral irrigator, dental floss and interdental brushes)
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 46
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 46
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•WSL with a modified score 3 (Gorelick et al. 1982) on UFT at debonding
•Ongoing oral or dental treatment except emergency treatment
•Known hypersensitivity or allergy to study products and standard toothpaste ingredients and/or dental material used in the present study
•Known hypersensitivity or allergy to placebo gel ingredients: Acid Yellow (E 104), Sunset Yellow (E 110), PEG-40 Hydrogenated Castor Oil, Methyl p-Hydroxybenzoate (Parabene E 218), Propyl p-Hydroxybenzoate (Parabene E 216)
•Professional administration of highly concentrated fluoride products like gels, tablets, varnishes, fillings etc. within 30 days prior to enrolment
•Professional administration or home-use of non-study related highly concentrated fluoride products like gels, tablets, varnishes, fillings etc. during the whole study
•Alterations in the teeth’s enamel, e.g. hypoplasia, fluorosis
•Chronic use of medication causing dry mouth
•Known xerostomia
•Medication for central nervous system conditions
•Any illness/condition potentially affecting the study outcome at investigator’s discretion
•Known pregnancy or breast feeding during the course of the study
•Participation in a clinical trial or receipt of an investigational compound/treatment within the last 30 days

发起方

GABA International AG