Effect of Using Supragingival Irrigators Containing Chlorhexidine on Oral Health in Patients With Blood Dyscrasia
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- improvement in oral health status
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 12 Years to 60 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
water jet irrigator
patients used supra-gingival irrigators as an oral health measure
Intervention: supragingival irrigators containing chlorhexidine (Device)
control group
patients in this group received routine oral health care protocols.
Outcomes
Primary Outcomes
improvement in oral health status
Time Frame: 3 weeks
improvement of oral health was measured by oral health index simplified(OHI-S)
Secondary Outcomes
- incidence of oral mucositis(3 weeks)
Investigators
Pegah Mosannen Mozafari
assistant professor of oral medicine
Mashhad University of Medical Sciences