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

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: DRKS00023697
• Lead Sponsor: Poliklinik für Kieferorthopädie,Universitätsklinikum Regensburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-26
• Study Completion: 2021-12-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.)

Study & Design

• Study Type: interventional
• Study Design: Not specified