Comparative effectiveness of ProSeal Sealant and Elmex Fluid for preventing white-spot lesions and gingivitis in fixed orthodontic treatment of patients - a randomized controlled trial

Poliklinik für Kieferorthopädie,Universitätsklinikum Regensburg0 个研究点目标入组 128 人开始时间: 2020年11月26日最近更新: 2024年8月19日

适应症

试验速览

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•Patients before the start of a fixed orthodontic therapy using the buccal technique (in both dental arches) with a minimum expected treatment duration of 6 months at the examining orthodontist (no move, etc.)
•Bonding of the brackets in the upper and lower arches on the same day (T0)
•no previous or interrupted fixed orthodontic therapy
•at least 15 permanent incisors, canines and premolars present or erupted in both dental arches (5-5)
•At least 15 permanent anterior teeth and premolars in both dental arches are intended to be affixed with a bracket (=15 tooth surfaces / participant).

•Patients = 18 years (adults)
•Pregnancy or breastfeeding
•Application of a dental fluoride varnish or a sealer within the last 12 months
•Changes in the enamel on the teeth (fluorosis, hypocalcification, etc.)
•Fillings and restorations in buccal tooth surfaces (glued with brackets)
•Syndrome patients and patients with limited oral hygiene skills or ability to properly conduct the study
•Systemic, endocrine or oral diseases (diabetes, periodontitis, open oral wounds / ulcers, etc.), poor general condition
•Alcohol / drug abuse, long-term medication / antisialoga / steroids or other drugs that affect saliva, biofilm or the tooth support system in the last 6 months
•Local fluoride content in domestic drinking water> 0.2ppm F-
•Allergy / intolerance to fluorides or the preparations used
•Missing written declaration of consent
•Patients who do not agree to comply with the study protocol (no additional fluoride intake / PZR, dental treatment in consultation with an orthodontist, oral hygiene behavior, etc.)

发起方

Poliklinik für Kieferorthopädie,Universitätsklinikum Regensburg