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临床试验/NCT02873949
NCT02873949已完成不适用

Analysis of Soluble TREM (Triggering Receptor Expressed on Myeloid Cells)-1 and -2 in Crevicular Fluid and Associated Bacterial Flora in Patients Affected by Periodontitis

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Average concentration (quantified with ELISA assay) of soluble TREM-1 and TREM-2 in crevicular fluid from 2 distant sites affected by periodontitis and 1 healthy site of each periodontitis patients at first consultation

研究概览

简要总结

Etiopathology of periodontitis is complex and various risk factors are known :

  • Bacterial factors: major risk factor. Although the presence of periodontopathogen bacteria is necessary for the onset of periodontitis, these microorganisms are not sufficient for progression of all periodontal disease.
  • Immune factor: host immune response modulates the disease evolution to destruction or recovery. The most studied cytokine in periodontology is IL-1 that induces various immune reactions and bone resorption directly or indirectly through the stimulation of prostaglandin E2 (PGE2) release. PGE2 activates the matrix metalloproteinases that are responsible of the degradation of bone extracellular matrix.

Cytokine production, especially TNFα, IL-1β, IL-6 and IL-8, by some immune cells is modulated by new identified molecules such as Triggering Receptor Expressed on Myeloid cells (TREM) whose role in periodontitis is unknown.

The purpose of this study is to compare concentrations of soluble TREM-1 and TREM-2 markers in infected sites and in healthy sites in patients affected by periodontitis.

Other purposes are

  1. Comparison of soluble TREM-1 and TREM-2 concentrations in healthy sites in patients affected by periodontitis and in healthy patients
  2. Comparison of soluble TREM-1 and TREM-2 concentrations before and after etiologic periodontitis treatment
  3. Estimation of the correlation between soluble TREM-1 and TREM-2 concentrations and clinical signs of periodontitis
  4. Description of soluble TREM-1/TREM-2 ratio before and after etiologic treatment
  5. Description of presence of some bacteria in sites analyzed for soluble TREM-1 and TREM-2
  6. Search for the most observed bacteria in presence of high concentrations of soluble TREM-1 and TREM-2 before and after etiologic treatment
  7. Evaluation of the impact of psychological stress measured through salivary cortisol level in saliva on TREM-1 and -2 expression
  8. Evaluation of the impact of psychological stress through stress and anxiety auto-questionnaires (Spielberger and Cohen) on soluble TREM-1 and TREM-2 concentrations in crevicular fluid of healthy and pathologic teeth.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

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

  • Affiliation to social security plan
  • Absence of refusal of patient
  • Periodontal patients:
  • Affected by moderate to severe chronic periodontitis
  • At least 2 distinct infected sites with periodontal pocket depth ≥ 5mm
  • Having not received any root planing during last 6 months before visit
  • No periodontitis
  • Consulting for dental checkup and eventually scaling

排除标准

  • Pregnant women (change in bacterial flora) and breast-feeding
  • Administration of systemic antibiotherapy or any treatment influencing periodontal environment (anti-inflammatory, anti-epileptic, immune-suppressor, calcium inhibitor) during 6 months before sample collection
  • Patients having a pathology needing a prophylactic antibiotherapy (possibly influencing the treatment)
  • Teeth with periapical inflammatory lesions of endodontic origin
  • Person under guardianship
  • Periodontal patients:
  • Root planing during last 6 months before visit
  • Periodontitis

研究组 & 干预措施

1. Periodontitis patients

Other

30 patients consulting at Odontology department for periodontal treatment

干预措施: Crevicular samples (1-10µl) (Biological)

1. Periodontitis patients

Other

30 patients consulting at Odontology department for periodontal treatment

干预措施: Saliva samples (1ml) (Biological)

1. Periodontitis patients

Other

30 patients consulting at Odontology department for periodontal treatment

干预措施: Etiologic treatment (Other)

1. Periodontitis patients

Other

30 patients consulting at Odontology department for periodontal treatment

干预措施: Psychometric tests (Other)

2. Control

Other

10 patients not affected by periodontitis consulting at Odontology department for checkup of teeth state and/or scaling

干预措施: Saliva samples (1ml) (Biological)

2. Control

Other

10 patients not affected by periodontitis consulting at Odontology department for checkup of teeth state and/or scaling

干预措施: Crevicular samples (1-10µl) (Biological)

2. Control

Other

10 patients not affected by periodontitis consulting at Odontology department for checkup of teeth state and/or scaling

干预措施: Psychometric tests (Other)

结局指标

主要结局

Average concentration (quantified with ELISA assay) of soluble TREM-1 and TREM-2 in crevicular fluid from 2 distant sites affected by periodontitis and 1 healthy site of each periodontitis patients at first consultation

时间窗: day 0

次要结局

  • Average concentration (quantified with ELISA assay) of soluble TREM-1 and TREM-2 in crevicular fluid from healthy sites of periodontitis patients and non-periodontitis patients at first consultation(day 0)
  • Identification of periodontal bacterial flora(day 0 and after 13 to 15 weeks (after etiologic treatment of periodontitis patients))
  • Psychological stress score with Cohen Perceived Stress Scale(day 0)
  • Psychological stress score with Spielberger State-Trait Anxiety Inventory(day 0)
  • Average concentration (quantified with ELISA assay) of soluble TREM-1 and TREM-2 in crevicular fluid of periodontitis patients before and after etiologic treatment of periodontitis(day 0 and after 13 to 15 weeks (after etiologic treatment of periodontitis patients))
  • Quantification of salivary cortisol by ELISA to measure psychological stress(day 0)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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