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临床试验/NCT04909840
NCT04909840已完成不适用

Effectiveness of the Use of Dental Floss for Gengivite Treatment in Adults: a Randomized Clinical Trial

Universidade Federal de Santa Maria2 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2018年6月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
76
试验地点
2
主要终点
gingival condition

研究概览

简要总结

Bacterial plaque-induced gingivitis is considered the most common oral disease in dentate individuals and the most frequent type of periodontal disease. Manual brushing is the most widely used method for mechanical plaque self-control and, consequently, prevention and treatment of gingivitis. The effectiveness of brushing, however, is questionable in interproximal areas. Thus, interdental cleaning is recognized as an essential part of maintaining gingival health and the most recommended interdental device is dental floss. However, there is weak scientific evidence available about the recommendation for daily flossing. The objective of this randomized blinded trial is to evaluate the efficacy and effectiveness of oral hygiene using soft toothbrush associated with dental floss versus soft toothbrush in maintaining the gingival condition in adults without loss of insertion. Seventy-six subjects with generalized gingivitis at proximal sites will be randomized into two experimental groups according to the use of dental floss: Manual toothbrushing group without the use of dental floss (without dental floss) and Group dental toothbrushing and dental flossing (dental floss). During a period of 8 weeks, the efficacy of the use of the toothbrush associated with the use of the dental floss will be evaluated. After this period, the baseline of the effectiveness study begins. After this period, the baseline of the effectiveness study begins. Participants will be followed up for another 12 months to evaluate the effectiveness of flossing. The parameters Index of Gingival Bleeding (GB) and Plaque Index (PI) will be evaluated at the baseline, 60, 120, 240 and 360 days. Descriptive analysis of GB and PI data will be performed using means, standard deviations and mean percentage of sites with different GB and PI scores. The differences in the means of GB and PI over time between groups and within the same group will be analyzed using the Poisson Multilevel Regression model. The main outcome will be the maintenance of the gingival condition. The difference in interventions will be compared using the chi-square test with significance level of 5%. Adults with less than 15% of sites with gingival bleeding will be considered healthy.

详细描述

Plaque-induced gingivitis is an inflammation caused by the accumulation of microorganisms around the gingival margins (MARIOTTI, 1999). The bacterial etiology of gingivitis was established by Löe et al. (1965). In this study, the accumulation of plaque on healthy gingiva produced gingivitis between 10 and 21 days and the restitution of oral hygiene procedures for 7 to 10 days reestablished gingival health. Epidemiological data show a high prevalence of gingivitis in the adult population of developed and developing countries (LI et al., 2010; MINISTÉRIO DA SAÚDE, 2011), besides being the most frequent type of periodontal disease (PAGE; BAAB, 1985).

The main clinical outcomes of gingivitis are edema, color change, probing bleeding, increased gingival exudate and sensitivity (PAGE, SCHROEDER, 1976; MARIOTTI, 1999). The clinical signs are restricted to the gingiva and are reversible with the removal of the etiological factor without any damage to the support periodontium (MARIOTTI, 1999). In adition to the local repercussions, the gingival condition has an impact on the quality of life. Self-perception of swollen gums and gingival pain were associated with reduced quality of life (NEEDLEMAN et al., 2004).

Gingivitis is a risk factor in the clinical course of chronic periodontitis. Lang et al. (2009) found that teeth associated with inflamed gingiva had a significantly greater risk of tooth loss than teeth with healthy or slightly inflamed gingiva. Hugoson et al. (2008) showed that improvements in plaque control reduced the prevalence of gingivitis and moderate periodontitis in four cross-sectional studies conducted over 30 years in Sweden. Thus, prevention and treatment of gingivitis can indirectly reduce tooth loss.

The mechanical control of the supragingival plaque is the main mechanism of prevention and treatment of gingivitis (PINTO et al., 2013; SAMBUNJAK et al., 2011). The benefits of adequate plaque control include maintaining a functional dentition, optimizing aesthetic values such as appearance and good breath, reducing the risk of loss of periodontal attachment, and the need for complex, uncomfortable, and costly periodontal treatment (CLAYDON, 2008). In addition, the improvement in periodontal clinical indicators is correlated with an increase in quality of life related to oral health in adults (SHANBHAG; DAHIYA; CROUCHER, 2013).

Manual brushing is the most commonly used method for plaque control. (VAN DER WEIJDEIN; SLOT, 2015). The effectiveness of this procedure depends on the individual ability to remove plaque and the frequency at which this removal is performed (JEPSEN, 1998). The XI European Workshop of Periodontology recommended the daily brushing twice daily with the use of fluoride dentifrice (CHAPPLE et al., 2015). However, Pinto et al. (2013) demonstrated that mechanical self-control with 24-hour frequency is able to prevent gingivitis in subjects with no history of periodontitis. A systematic review showed that a single brushing exercise reduces plaque levels by approximately 42% (SLOT et al., 2012). Randomized clinical trials (ROSEMA et al., 2008; SCHIFF et al., 2006; SHARMA et al., 2002) have shown that manual brushing without the aid of interdental plaque removal devices reduces plaque and gingivitis levels and maintains gingival health.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals with at least 18 years of age, without loss of proximal clinical insertion, with papilla completely filling the interdental space and with at least 24 teeth will be eligible.
  • Individuals should present gingivitis in 15% of the proximal sites (gingival marginal bleeding, gingival index score 2, LÖE, 1967). Distal sites of the posterior teeth will not be counted in the analysis because they are not areas of flossing.

排除标准

  • Dental students, individuals with xerostomia, pregnant women, diabetics, smokers, patients with orthodontic appliances and/or containment, individuals requiring antimicrobial prophylaxis to perform oral exams; who have used antibiotics/anti-inflammatories for the last three months and who have psychomotor disorders.

结局指标

主要结局

gingival condition

时间窗: 14 months

The gingival condition will be assessed through the Gingival Index (GI) (Löe, 1967)

次要结局

  • Oral Health-related Quality of Life(14 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carlos Heitor Cunha Moreira

Principal Investigador

Universidade Federal de Santa Maria

研究点 (2)

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