Periodontal Therapy in Thalassemia Major Patients

Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03311243
• Other study ID #: FR-17-67
• Status: Completed
• Phase: N/A
• First received: October 11, 2017
• Last updated: October 16, 2017
• Start date: January 11, 2016
• Est. completion date: June 16, 2017

Study information

• Verified date: October 2017
• Source: King Saud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 16, 2017
• Est. primary completion date: April 10, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

1. Written and verbal consent

2. (TM-ß) 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

Related Conditions & MeSH terms

• beta-Thalassemia
• Chronic Periodontitis
• Periodontitis
• Thalassemia
• Thalassemia Major

Intervention

Procedure:
• Non surgical periodontal therapy

Drug:
• Chemical plaque control

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
King Saud University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systemic pro-inflammatory cytokines	IL-6 and TNF-alpha potent proinflammatory cytokines	6 weeks