Effect of Non-surgical Periodontal Therapy on Systemic Inflammation in Thalassemia Major Patients With Chronic Periodontitis: A Randomised Controlled Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Non surgical periodontal therapy
- Conditions
- Thalassemia Major
- Sponsor
- King Saud University
- Enrollment
- 52
- Primary Endpoint
- Systemic pro-inflammatory cytokines
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Zohaib Akram
Principal investigator
King Saud University
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
β-Thalassemia major (TM- β)
Intervention: Non surgical periodontal therapy
β-Thalassemia major (TM- β)
Intervention: Chemical plaque control
Systemically healthy controls
Intervention: Non surgical periodontal therapy
Systemically healthy controls
Intervention: Chemical plaque control
Outcomes
Primary Outcomes
Systemic pro-inflammatory cytokines
Time Frame: 6 weeks
IL-6 and TNF-alpha potent proinflammatory cytokines