跳至主要内容
临床试验/NCT06433232
NCT06433232招募中不适用

Effect of Endodontic Treatment on Inflammatory Markers, Disease Activity and Periapical Healing in Rheumatoid Arthritis Patients With Apical Periodontitis : A Prospective Interventional Study

Postgraduate Institute of Dental Sciences Rohtak2 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2024年5月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
76
试验地点
2
主要终点
Change in levels of hsCRP

研究概览

简要总结

SUMMARY TITLE: "Effect of endodontic treatment on inflammatory markers, disease activity and periapical healing in rheumatoid arthritis patients with apical periodontitis"

RATIONALE: Chronic inflammation plays a pivotal role in rheumatoid arthritis as subjects present with elevated serum levels of numerous cytokines such as IL-1, IL-6, 1L-12, IL-17, tumour necrosis factor-alpha, RANK and RANK Ligand. Periodontal and pulpal inflammation are two major low grade chronic inflammatory diseases of the oral cavity. Apical periodontitis extends from the chronic inflammatory process that originated in the dental pulp to surround the apex of the tooth. Thus Rheumatoid arthritis and apical periodontitis converge upon common pathway of inflammation. The scientific literature has also shown to provide potential link between endodontic infection and rheumatoid arthritis. The evidence of increased prevalence of apical periodontitis in subjects of rheumatoid arthritis is provided mainly by cross-sectional and case control studies. Interventional studies have been performed in subjects with rheumatoid arthritis and periodontal disease, with results depicting beneficial effect of periodontal therapy in patients of rheumatoid arthritis. To best of our knowledge no interventional study has been performed to assess the healing pattern of apical periodontitis in subjects of rheumatoid arthritis and subsequently effect of endodontic intervention on inflammatory profile and disease burden in the same.

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

性别
All
接受健康志愿者

入选标准

  • Age of patients 30-65 years 2.Definite diagnosis of Rheumatoid arthritis based on ACR/EULAR 2010 criteria[28] i.e a score of 6 or greater out of 10 from the individual scores in four domains: number and site of involved joints (range 0-5), serological abnormality (range 0-3), elevated acute-phase response (range 0-1) and symptom duration (two levels; range 0-1)
  • The periapical index (PAI) will be used to evaluate the periapical status patients with PAI >or=3 as given by Orstavik[29] will be included
  • Presence of total teeth >/= 12

排除标准

  • Patients with periodontitis, pocket depth and CAL>5mm (stage 3, 4) will be excluded.
  • Pregnancy; lactation & contraceptives
  • Patients with any other systemic disease other than Rheumatoid arthritis i.e Diabetes, HIV, Chronic Liver Disease, Chronic Kidney disease and Cardiovascular disease
  • Conditions known to alter systemic inflammatory markers i.e orthopaedic trauma, surgery and viral infections
  • Patients with BMI >/= 30
  • Medications (during last 3 months) known to affect systemic inflammatory markers (systemic steroids, immunosuppressants, hormone replacement therapy, contraceptives and systemic antibiotics)

结局指标

主要结局

Change in levels of hsCRP

时间窗: 12 MONTHS

次要结局

  • Change in levels of ESR(12 MONTHS)
  • Change in SDAI(12 MONTHS)
  • Quality of life using OHIP-14(12 MONTHS)

研究者

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

Sanjay Tewari

principal pgids

Postgraduate Institute of Dental Sciences Rohtak

研究点 (2)

Loading locations...

相似试验