Fluoride Varnish, Ozone, Octenidin and WSLs in Orthodontic Patients

NCT04992481 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2021-08-12

No results posted yet for this study

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.

Conditions

  • White Spot Lesion of Tooth

Interventions

PROCEDURE

PMTC

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).

PROCEDURE

fluoride varnish

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).

PROCEDURE

gaseous ozone therapy

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.

PROCEDURE

domestic octenidin mouth rinse

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.

Sponsors & Collaborators

  • Pomeranian Medical University Szczecin

    lead OTHER

Principal Investigators

  • Katarzyna Grocholewicz, DDS, PhD · Pomeranian Medical University, Szczecin, Poland

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-01
Primary Completion
2016-06-30
Completion
2016-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04992481 on ClinicalTrials.gov