Influence of Fluoride Varnish, Ozone and Octenidin on the Incidence of White Spot Lesions and Caries During Orthodontic Treatment - a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 主要终点
- WSLs presence on teeth
研究概览
简要总结
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.
详细描述
In the recent years orthodontic treatment has become very popular. Patients seek orthodontic treatment, mainly to improve the esthetics of their smiles, since appearance has become extremely important in the modern society. Another reason to have orthodontic treatment is striving for a better, more comfortable occlusion. However, complications of orthodontic therapy may occur.
Bonding an orthodontic appliance creates environment for bacterial adhesion, with reduced salivary flow. The most retentive sites are: area between the bracket upper surface and gingival margin as well as proximal surfaces. The resulting pH reduction in this area promotes the demineralization process. Enamel demineralization, being an initial stage of caries as well as gingival inflammation belong to the most prevalent detrimental effects resulting from increased accumulation of the biofilm and difficulty to clean these surfaces.
With treatment initiation the microbial environment of the oral cavity changes - increases the number of Lactobacillus and Streptococcus mutans in biofilm.
White spot lesions (WSLs) are the first sings of carious lesions on enamel that can be detected with the naked eye and result from demineralization. WSLs may arise as early as four or even two weeks following bonding fixed appliance creating a need for a clinical intervention.
The most often affected teeth are lateral incisors, followed by canines, premolars and central incisors. There is no side predilection, or difference for upper and lower dental arches. At least one new initial carious lesion is found in 72,9% patients, whereas in 61% cavities develop during the first twelve months of orthodontic treatment. A fast increase of the incidence of WSLs is observed during the first six months of treatment - initial caries is found in 38% patients, after 12 months WSLs are found in 46% patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
The patients have been randomly divided (using number random generator) into five groups (n=30), including four study groups (I, II, III, IV) and one control group (K).
入排标准
- 年龄范围
- 16 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •permanent dentition
- •fixed appliances bonded to both dental arches (no more than 4 weeks prior to the study)
排除标准
- •inborn tooth anormalities
- •prosthetics restorations
结局指标
主要结局
WSLs presence on teeth
时间窗: 12 months
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. WSL index according to Gorelick et al. \[28\] was used as follows: 0 - no visible WSL or surface disruption (no demineralization) * visible WSL, covering less than 1/3 of surface, without surface disruption (mild demineralization) * visible WSL, covering more than 1/3 of the surface, with a roughened surface, but not requiring restoration (moderate demineralization) * visible cavitation, requiring restoration (severe demineralization) Every dental surface was subjected to visual-tactile examination performed on a dental chair with proper dental lighting, using dental probe and a mirror. Caries was diagnosed on the level of cavitation, the presence of fillings has been noted as well.
次要结局
未报告次要终点
研究者
Katarzyna Grocholewicz
Professor
Pomeranian Medical University Szczecin