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临床试验/NCT03311243
NCT03311243已完成不适用

Effect of Non-surgical Periodontal Therapy on Systemic Inflammation in Thalassemia Major Patients With Chronic Periodontitis: A Randomised Controlled Clinical Trial

King Saud University0 个研究点目标入组 52 人开始时间: 2016年1月11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
入组人数
52
主要终点
Systemic pro-inflammatory cytokines

研究概览

简要总结

The study aims to evaluate the effect of local non surgical periodontal therapy on the systemic pro-inflammatory markers in the β-thalassemia (TM-β) patients with chronic periodontitis and systemically healthy demographically matched controls with chronic periodontitis. Both groups will receive non surgical periodontal therapy.

详细描述

Treatment modalities in patients with thalassemia include long-term transfusion therapy, iron chelation, splenectomy, allogeneic hematopoietic transplantation and supportive measures. Attempts to downgrade the systemic proinflammation and thereby reducing the morbidity of the disease warrants investigation in patients with β-thalassemia (TM-β). In blood disorders, as with most other diseases, achieving and maintaining inflammatory homeostasis is essential and necessary for survival. Both TM and gingival diseases cause increased levels of pro-inflammatory cytokines in the body fluids. Moreover, higher prevalence of gingival diseases is reported in children with TM. With oral hygiene maintenance and care, down-regulation of the systemic burden of the disease might be attained which will subsequently aid in achieving reduced morbidity in children with TM.

Both the groups will receive non surgical periodontal therapy (scaling and root planing) with the chlorhexidine containing adjunct in the form of a mouthrinse. Additionally, they will be taught standard tooth brushing technique (Fones technique). Participants will receive both verbal instructions and practical demonstrations.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Written and verbal consent
  • (TM-β) patients with gingivitis
  • Age: ≥10 years
  • Patients who have received or are receiving iron chelation therapy with deferasirox, calcium, vitamin D, and regular erythrocyte transfusion.

排除标准

  • Presence of hepatitis B or C or HIV-AIDS (Human immunodeficiency Virus- Acquired immunodeficiency syndrome).
  • Presence of any other known systemic disease.
  • Use of antibiotics or anti-inflammatory drugs within the past 6 months.
  • Dental prophylaxes in the last 6 months

研究组 & 干预措施

β-Thalassemia major (TM- β)

Experimental

干预措施: Non surgical periodontal therapy (Procedure)

β-Thalassemia major (TM- β)

Experimental

干预措施: Chemical plaque control (Drug)

Systemically healthy controls

Active Comparator

干预措施: Non surgical periodontal therapy (Procedure)

Systemically healthy controls

Active Comparator

干预措施: Chemical plaque control (Drug)

结局指标

主要结局

Systemic pro-inflammatory cytokines

时间窗: 6 weeks

IL-6 and TNF-alpha potent proinflammatory cytokines

次要结局

未报告次要终点

研究者

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

Zohaib Akram

Principal investigator

King Saud University

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