Effect of Supragingival Irrigators Containing Chlorhexidine on Oral Health in Blood Dyscrasia

Study Overview
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Brief Summary
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in this study , effectiveness of supragingival irrigators containing chlorhexidine is compared with routine oral health measures in patients with blood dyscrasia whom can not use effective oral health measures(e.g brushing ) due to their systemic condition(e,g,neutropenia ,thrombocytopenia,..)

Detailed Description
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Since some patients with hematologic malignancies cannot brush effectively and are at increased risk of bleeding and infection due to severe neutropenia and thrombocytopenia we want to access whether a none invasive method ( water jet systems containing chlorhexidine ) Can help this patients to get better oral health indexes in comparison with routine oral health measures in these type of patients.

Official Title
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Effect of Using Supragingival Irrigators Containing Chlorhexidine on Oral Health in Patients With Blood Dyscrasia

Conditions
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Severe Neutropenia, Thrombocytopenia, Chemotherapy, Blood Dyscrasia Patients

Intervention / Treatment
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* Device: supragingival irrigators containing chlorhexidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with a blood dyscrasia, severe neutropenia and thrombocytopenia, absence of periodontitis, absence of any oral mucosal lesion in onset of study, patient consent Exclusion Criteria: diabetes mellitus, observation of any side effect (resulted from the device), severe oral mucositis in intervention group(grade 3 and4 WHO), edentulousness, intolerance of device in severely malaise patients, patient death

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: water jet irrigator<br>patients used supra-gingival irrigators as an oral health measure | Device: supragingival irrigators containing chlorhexidine<br>* patients received irrigation by oxyjet supra gingival irrigators containing chlorhexidine for at least 3 minutes for all dentulous regions of jaws which was performed by researchers once daily.<br>* Other names: Oral-B Braun Oxyjet irrigators;|
| No Intervention: control group<br>patients in this group received routine oral health care protocols. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement in oral health status | improvement of oral health was measured by oral health index simplified(OHI-S) | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of oral mucositis | incidence of mucositis due to Who criteria explored by clinical examination | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral irrigator, leukemia, blood dyscrasia, Oral Health Index Simplified (OHI-S), supra gingival irrigator