Periodontal Therapy in Thalassemia Major Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Thalassemia Major, Chronic Periodontitis

Intervention / Treatment
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* Procedure: Non surgical periodontal therapy
* Drug: Chemical plaque control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: β-Thalassemia major (TM- β)<br> | Procedure: Non surgical periodontal therapy<br> <br> Drug: Chemical plaque control<br> <br> |
| Active Comparator: Systemically healthy controls<br> | Procedure: Non surgical periodontal therapy<br> <br> Drug: Chemical plaque control<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic pro-inflammatory cytokines | IL-6 and TNF-alpha potent proinflammatory cytokines | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cytokines, scaling root planing, oral hygiene, systemic inflammation