Periodontal Therapy in Thalassemia Major Patients

King Saud University

Status: Completed

Conditions: Chronic Periodontitis; Thalassemia Major

Treatments: Drug: Chemical plaque control; Procedure: Non surgical periodontal therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03311243

FR-17-67

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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52 participants in 2 patient groups

β-Thalassemia major (TM- β)

Experimental group

Treatment:

Procedure: Non surgical periodontal therapy

Drug: Chemical plaque control

Systemically healthy controls

Active Comparator group

Treatment:

Procedure: Non surgical periodontal therapy

Drug: Chemical plaque control