At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Influence of Fluoride Varnish, Ozone and Octenidin on the Incidence of White Spot Lesions and Caries During Orthodontic Treatment - a Randomized Clinical Trial
In Brief
A clinical study evaluating PMTC, fluoride varnish, and 2 other interventions for White Spot Lesion of Tooth. Completed, enrolled 150 participants.
Detailed Summary
Objectives: to assess the efficiency of four prophylactic protocols on white spot lesions during orthodontic treatment: 1. professional mechanical tooth cleaning (PMTC)+fluoride varnish, 2. PMTC+fluoride varnish+gaseous ozone therapy 3. PMTC+fluoride varnish+domestic octenidin mouth rinse, 4. PMTC+fluoride varnish+domestic octenidin mouth rinse+ gaseous ozone therapy versus a control group not subjected to any prophylactic program. Materials and Methods: Patients (n=150, 111 women and 39 men, age 16-50y,) who began orthodontic treatment with fixed appliances bonded to both dental arches have been provided with detailed initial oral hygiene instruction recommendations. The hygienic recommendations comprised: toothbrushing every surface after every meal (4 minutes) with a fluoridated toothpaste (1450 ppm) using the roll and Bass methods with a soft toothbrush recommended for fixed appliance, interdental toothbrushes, single-tufted brushes and dental floss recommended for fixed appliance. An instruction leaflet has been delivered to every subject, as well. A reinstruction was made during every control visit referring to the results of the oral hygiene assessment. Subsequently, the patients were randomly allocated (using number random generator) into five groups (n=30), including four study groups (I, II, III, IV) and one control group (K). Group I: professional mechanical tooth cleaning (PMTC)+fluoride varnish, group II: PMTC+fluoride varnish+gaseous ozone therapy, group III: PMTC+fluoride varnish+domestic octenidin mouth rinse, group IV: PMTC+fluoride varnish+domestic octenidin mouth rinse+ gaseous ozone therapy, control group (K) not subjected to any prophylactic program. The period of observation was 12 months, with prophylactic visits every four weeks and examinations every 12 weeks. The assessment of white spot lesions was proceeded on the labial surfaces of upper and lower teeth, with patient on the dental chair in proper dental lighting, after cleaning and drying the assessed surfaces.
Study Details
Timeline
Interventions
In patients from the study groups I, II, III, IV a professional mechanical tooth cleaning (PMTC) including air-polishing was proceeded on every visit using a glycine-based prophylaxis powder (Air-Flow Soft, EMS, Switzerland).
In patients from groups I, II, III, IV a fluoride varnish of 5% NaF (Profluorid Varnish, Voco, Germany) was applied with a microbrush. Every patient was instructed to stop from drinking and eating for the next two hours (as recommended by the manufacturer).
Patients from groups II and IV were additionally subjected to in-office ozone therapy using OzonyTron-OZ (Mymed, Germany). Ozone was applied on a silicone double-jaw tray of a proper size (allowing even ozone distribution in the oral cavity) following professional mechanical tooth cleaning. A Full Mouth Desinfection program lasting 5 minutes was used.
Patients from groups III and IV received a domestic mouthrinse (Octenidol MD, Schülke, Germany) and were recommended to use 15 ml of the liquid for 30 seconds after evening toothbrushing.