NL-OMON46094已完成不适用
The influence of apical periodontitis on the concentration of inflammatory mediators in peripheral blood plasma and the metagenomic profiling of endodontic infections. - AP, health & metagenome
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Intervention group
- •- The subject is 18 - 80 years old.
- •-After intra-oral examination, AP has been confirmed with an intra-oral radiograph and appears on the radiograph as a radiolucent area around one or more root tips of the affected tooth. AP is diagnosed when in the periapical region, the periodontal ligament is at least twice as wide as in the mid-root regions. A root canal treatment has a poor prognosis or the patient would rather have the affected tooth extracted. The AP tooth is non-symptomatic.
- •- No other teeth have AP. To confirm this, front teeth are clinically examined. Discoloured teeth or teeth with restorations that do not respond to cold testing or that are tender to percussion or palpation will also be examined with an intra-oral radiograph. In the (pre)molar region, recent bite-wing radiographs are used to screen for deep restorations or dental caries. When there are doubts about the vitality of restored or decayed (pre)molars an additional radiograph is taken.
- •- The subject has completed the medical history questionnaire.
- •- The subject wants to participate and donate six blood samples at six different time points and the subject wants to donate the extracted tooth. The subject has signed the IC letter.
- •- The subject will not undergo dental hygienist* treatments during the study.;Non-intervention group
- •- The subject is 18 - 80 years old.
- •- The subject has not had endodontic treatment in the past or previously root-canal treated teeth show no signs or symptoms of AP.
- •- The subject has completed the medical history questionnaire and is classified as healthy.
- •- The subject wants to participate and donate six blood samples at six different time points and the subject wants to donate the extracted tooth. The subject has signed the IC letter.
- •- The subject will not undergo dental hygienist* treatments during the study.
排除标准
- •Intervention group
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •- pregnancy or lactation
- •- diabetes mellitus type I,
- •- chronic inflammatory diseases like m. Crohn
- •- use of antibiotics 1 month prior with an indication other than AP of the aimed tooth.
- •- use of corticosteroids or NSAIDs
- •- chemotherapy or previous head/neck irradiation
- •- any surgery 6 months prior
- •- any existing extra-oral swelling
- •- malaise, colds or influenza one week before or at the start of the study
- •- prosthesis carriers with stomatitis
- •- absence of periapical radiolucency in the presence of tenderness to percussion.
- •- absence of periapical radiolucency in the absence of sensitivity
- •- previous surgery on tooth considered
- •- vertical root fracture of tooth considered
- •- localised periodontitis affecting tooth considered with absence of periodontal disease at other sites;Non-intervention group
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •- pregnancy or lactation
- •- diabetes mellitus type I
- •- chronic inflammatory diseases like m. Crohn
- •- use of antibiotics 1 month prior
- •- use of corticosteroids or NSAIDs
- •- chemotherapy or previous head/neck irradiation
- •- any surgery 6 months prior
- •- any existing extra-oral swelling
- •- malaise, colds or influenza one week before or at the start of the study
- •- prosthesis carriers with stomatitis;Late exclusion takes place when in the
- •Intervention group
- •- the healing has been complicated, think alveolitis
- •- the use of antibiotics for any infection
- •- change in periodontal scoring index
- •- change in health/surgery of any kind
- •- take-up smoking
- •- other changes in lifestyle
- •- malaise due to colds, influenza etc. one week before or at the blood-draw appointment ;Or in the non-intervention group
- •- the use of antibiotics for any infection
- •- change in health/surgery of any kind
- •- take-up smoking
- •- other changes in lifestyle
- •- malaise due to colds, influenza etc. one week before or at the blood-draw appointment
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