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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03311243
Enrollment
52
Registered
2017-10-17
Start date
2016-01-11
Completion date
2017-06-16
Last updated
2017-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Periodontitis, Thalassemia Major

Keywords

cytokines, scaling root planing, oral hygiene, systemic inflammation

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.

Interventions

PROCEDURENon surgical periodontal therapy
DRUGChemical plaque control

Sponsors

King Saud University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Systemic pro-inflammatory cytokines6 weeksIL-6 and TNF-alpha potent proinflammatory cytokines

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026