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Periodontal Therapy in Thalassemia Major Patients

Primary Purpose

Thalassemia Major, Chronic Periodontitis

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Non surgical periodontal therapy

Chemical plaque control

About this trial

This is an interventional treatment trial for Thalassemia Major focused on measuring cytokines, scaling root planing, oral hygiene, systemic inflammation

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Written and verbal consent
(TM-β) patients with gingivitis
Age: ≥10 years
Patients who have received or are receiving iron chelation therapy with deferasirox, calcium, vitamin D, and regular erythrocyte transfusion.

Exclusion Criteria:

Presence of hepatitis B or C or HIV-AIDS (Human immunodeficiency Virus- Acquired immunodeficiency syndrome).
Presence of any other known systemic disease.
Use of antibiotics or anti-inflammatory drugs within the past 6 months.
Dental prophylaxes in the last 6 months

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

β-Thalassemia major (TM- β)

Systemically healthy controls

Arm Description

Outcomes

Primary Outcome Measures

Systemic pro-inflammatory cytokines

IL-6 and TNF-alpha potent proinflammatory cytokines

Secondary Outcome Measures

Full Information

NCT ID

NCT03311243

First Posted

October 11, 2017

Last Updated

October 16, 2017

Sponsor

King Saud University

1. Study Identification

Unique Protocol Identification Number

NCT03311243

Brief Title

Periodontal Therapy in Thalassemia Major Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

January 11, 2016 (Actual)

Primary Completion Date

April 10, 2017 (Actual)

Study Completion Date

June 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

King Saud University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thalassemia Major, Chronic Periodontitis

Keywords

cytokines, scaling root planing, oral hygiene, systemic inflammation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

β-Thalassemia major (TM- β)

Arm Type

Experimental

Arm Title

Systemically healthy controls

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

Non surgical periodontal therapy

Intervention Type

Drug

Intervention Name(s)

Chemical plaque control

Primary Outcome Measure Information:

Title

Systemic pro-inflammatory cytokines

Description

IL-6 and TNF-alpha potent proinflammatory cytokines

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written and verbal consent (TM-β) patients with gingivitis Age: ≥10 years Patients who have received or are receiving iron chelation therapy with deferasirox, calcium, vitamin D, and regular erythrocyte transfusion. Exclusion Criteria: Presence of hepatitis B or C or HIV-AIDS (Human immunodeficiency Virus- Acquired immunodeficiency syndrome). Presence of any other known systemic disease. Use of antibiotics or anti-inflammatory drugs within the past 6 months. Dental prophylaxes in the last 6 months

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Periodontal Therapy in Thalassemia Major Patients

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