Periodontal Therapy in Thalassemia Major Patients

Not Applicable

Completed

• Conditions: Chronic Periodontitis; Thalassemia Major
• Interventions: Procedure: Non surgical periodontal therapy; Drug: Chemical plaque control

• Registration Number: NCT03311243
• Lead Sponsor: King Saud University

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.

Study Timeline

• Study Start: 2016-01-11
• Primary Completion: 2017-04-10
• Study Completion: 2017-06-16
• Status Verified: 2017-10
• Study First Submitted: 2017-10-11
• Study First Submitted QC: 2017-10-11
• Last Update Submitted: 2017-10-16
• Study First Posted: 2017-10-17
• Last Update Posted: 2017-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
β-Thalassemia major (TM- β)	Chemical plaque control	-
Systemically healthy controls	Non surgical periodontal therapy	-
Systemically healthy controls	Chemical plaque control	-
β-Thalassemia major (TM- β)	Non surgical periodontal therapy	-

Primary Outcome Measures

Name	Time	Method
Systemic pro-inflammatory cytokines	6 weeks	IL-6 and TNF-alpha potent proinflammatory cytokines