Periodontal Therapy in Thalassemia Major Patients

NCT ID: NCT03311243

Last Updated: 2017-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-11
• Study Completion Date: 2017-06-16

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.

Conditions

Thalassemia Major; Chronic Periodontitis

Keywords

cytokines; scaling root planing; oral hygiene; systemic inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

β-Thalassemia major (TM- β)

Group Type: EXPERIMENTAL

Non surgical periodontal therapy

Intervention Type: PROCEDURE

Chemical plaque control

Intervention Type: DRUG

Systemically healthy controls

Group Type: ACTIVE_COMPARATOR

Non surgical periodontal therapy

Intervention Type: PROCEDURE

Chemical plaque control

Intervention Type: DRUG

Interventions

Non surgical periodontal therapy

Intervention Type: PROCEDURE

Chemical plaque control

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

King Saud University

OTHER

Sponsor Role: lead

Responsible Party

Zohaib Akram

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

FR-17-67

Identifier Type: -

Identifier Source: org_study_id