Effect of Non-surgical Periodontal Therapy on Systemic Inflammation in Thalassemia Major Patients With Chronic Periodontitis: A Randomised Controlled Clinical Trial
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
- 是
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)
干预措施: Non surgical periodontal therapy (Procedure)
β-Thalassemia major (TM- β)
干预措施: Chemical plaque control (Drug)
Systemically healthy controls
干预措施: Non surgical periodontal therapy (Procedure)
Systemically healthy controls
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
Zohaib Akram
Principal investigator
King Saud University
