Periodontal Therapy in Thalassemia Major Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis; Thalassemia Major
• Intervention / Treatment: Procedure: Non surgical periodontal therapy; Drug: Chemical plaque control

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: King Saud University

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2016
• Primary Completion (Actual): April 10, 2017
• Study Completion (Actual): June 16, 2017

Study Registration Dates

• First Submitted: October 11, 2017
• First Submitted That Met QC Criteria: October 11, 2017
• First Posted (Actual): October 17, 2017

Study Record Updates

• Last Update Posted (Actual): October 18, 2017
• Last Update Submitted That Met QC Criteria: October 16, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: cytokines; oral hygiene; scaling root planing; systemic inflammation
• Additional Relevant MeSH Terms: Hematologic Diseases; Genetic Diseases, Inborn; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Periodontitis; Chronic Periodontitis; Thalassemia; beta-Thalassemia
• Other Study ID Numbers: FR-17-67

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No