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临床试验/NCT04339309
NCT04339309已完成不适用

Comparison Between Two Non-surgical Periodontal Treatment Procedures With and Without Interdental Hygiene Devices in Periodontitis Patients: a Longitudinal Prospective Controlled Clinical Trial

Cairo University0 个研究点目标入组 52 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
52
主要终点
Bleeding on probing

研究概览

简要总结

Periodontitis is treated by regularly clearance of the disease-causing biofilm through domestic care and dental measures (Petersilka et al., 2002, Herrera et al., 2008). Healthy gums have intact papillae occluding the interdental area. Successful brushing cleans these areas; the prophylaxis of gingivitis for such patients does therefore not require special aids. In contrast, initial attachment loss as a result of inflammation or restorative therapy leads to additional cleaning needs, since the normal brush is not able to clean interdental areas as successful as vestibular and oral surfaces (Dörfer and Staehle, 2010).

It can be said that interdental brushes are the most effective tools for cleaning interdental spaces (Salzer et al., 2015). Compared with a toothbrush, they are the only tool showing better results of plaque removal and reduction of gingivitis (Slot et al., 2008). Therefore their use should not be restricted to older people with already reduced interdental papillae. A big advantage is that interdental brushes are generally easy to use. If brush sizes are chosen correctly, insertion and multiple forward and backward movement is sufficient to obtain com- plete cleaning of the interproximal surfaces. Additional cleaning by other means such as dental floss is not always necessary because interdental brushes clean approximal and subgingival surfaces sufficiently, providing the size was chosen correctly (Dörfer and Staehle, 2010).

Due to the above mentioned coherences and associations, this study includes the hypothesis that patients with periodontitis would benefit from the instruction and motivation of interdental brushes within the active periodontitis therapy in comparison to a periodontitis therapy without the instructed domestic interdental hygiene by a stronger reduction of clinical inflammatory characteristics (Salzer et al., 2015). The corresponding Zero-Hypothesis says that no difference would be found between both groups.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Generalized chronic periodontitis (CP)
  • Generalized aggressive periodontitis (AgP)
  • Availability for non-surgical periodontal therapy and reevaluation after 3±1 months.
  • Moderate to advanced severity of periodontitis (≥30% of the sites with attachment loss ≥3mm)
  • Age: 18 - 70 years
  • ≥16 scorable teeth, without root caries

排除标准

  • Localized chronic or aggressive periodontitis (<30% diseased teeth of all teeth)
  • Tumour(s) of the soft or hard tissues of the oral cavity.
  • Systematic disease, which include specific conditions to treat (e.g. prophylaxis of endocarditic)
  • Women who are aware of being pregnant or who are breastfeeding.
  • Forms of acute necrotizing ulcerating periodontitis

结局指标

主要结局

Bleeding on probing

时间窗: 3 months

Bleeding on probing (BOP) will be measured at least after the measurement of the CAL through recording bleeding sign at the site of clinical probing (six sites of each teeth).

次要结局

  • Clinical attachment level (CAL)(3 months)
  • Probing pocket depth(3 months)
  • Antibiotic use(3 months)

研究者

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

Prof. Dr. Karim Fawzy El-Sayed

Assistant Professor of Periodontology

Cairo University

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