Efficacy of the fluoride varnish enamelast for preventing white-spot lesions and gingivitis in fixed orthodontic treatment of patients with low to moderate caries risk - a randomized controlled trial

Not Applicable

• Conditions: K02.0; K05.0; K05.1; K03.6; Caries limited to enamel; Acute gingivitis; Chronic gingivitis; Deposits [accretions] on teeth

• Registration Number: DRKS00012533
• Lead Sponsor: Poliklinik für Kieferorthopädie,Universitätsklinikum Regensburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-08
• Study Completion: 2020-06-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

• Patients before starting a fixed orthodontic therapy in buccal technique (in both dental arches) with a minimum expected treatment period of 6 months,
• Bonding of brackets in the upper and lower arch on the same day (T0).
• no previous or paused fixed orthodontic therapy
• all permanent incisors, canines and premolars in both arches are present or erupted (5-5)
• All anterior teeth and premolars in both arches are intended to be fit with a bracket (20 tooth surfaces / participant).

Exclusion Criteria

• Patients = 18 years (adults)
• Pregnancy or lactation
• Application of a dental fluoride varnish or other caries-protective varnish preparations within the last 12 months
• Patients with a high caries risk (corresponding to 4 assessment parameters)
• Enamel alterations (fluorosis, hypocalcification, etc.)
• Fillings and restorations in buccal tooth surfaces (with bracket)
• Syndrome patients and patients with reduced oral hygiene ability or ability to perform the study properly
• systemic, endocrine or oral diseases (diabetes, periodontitis, open oral wounds / ulcers, etc.), poor general condition
• alcohol / drug abuse, smoking (tobacco), long-term medications or antibiotics / antisialoga / steroids or other medicines affecting the saliva, biofilm or the periodontal apparatus 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 consent
• Patients who are not prepared to comply with the protocol (no additional fluoride / PZR, dental treatment in consultation with orthodontists, oral hygiene, etc.)

Study & Design

• Study Type: interventional
• Study Design: Not specified