Back to resultsEffect of Supragingival Irrigators Containing Chlorhexidine on Oral Health in Blood Dyscrasia
Primary Purpose
Severe Neutropenia, Thrombocytopenia, Chemotherapy
Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
supragingival irrigators containing chlorhexidine
Sponsored by
About this trial
This is an interventional prevention trial for Severe Neutropenia focused on measuring oral irrigator, leukemia, blood dyscrasia, Oral Health Index Simplified (OHI-S), supra gingival irrigator
Eligibility Criteria
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
Sites / Locations
- Oral Medicine Department of Mashhad dental School,Oral and Maxillofacial diseases research center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
water jet irrigator
control group
Arm Description
patients used supra-gingival irrigators as an oral health measure
patients in this group received routine oral health care protocols.
Outcomes
Primary Outcome Measures
improvement in oral health status
improvement of oral health was measured by oral health index simplified(OHI-S)
Secondary Outcome Measures
incidence of oral mucositis
incidence of mucositis due to Who criteria explored by clinical examination
Full Information
NCT ID
NCT01974401
First Posted
October 26, 2013
Last Updated
October 26, 2013
Sponsor
Mashhad University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01974401
Brief Title
Effect of Supragingival Irrigators Containing Chlorhexidine on Oral Health in Blood Dyscrasia
Official Title
Effect of Using Supragingival Irrigators Containing Chlorhexidine on Oral Health in Patients With Blood Dyscrasia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mashhad University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Neutropenia, Thrombocytopenia, Chemotherapy, Blood Dyscrasia Patients
Keywords
oral irrigator, leukemia, blood dyscrasia, Oral Health Index Simplified (OHI-S), supra gingival irrigator
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
water jet irrigator
Arm Type
Active Comparator
Arm Description
patients used supra-gingival irrigators as an oral health measure
Arm Title
control group
Arm Type
No Intervention
Arm Description
patients in this group received routine oral health care protocols.
Intervention Type
Device
Intervention Name(s)
supragingival irrigators containing chlorhexidine
Other Intervention Name(s)
Oral-B Braun Oxyjet irrigators
Intervention Description
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.
Primary Outcome Measure Information:
Title
improvement in oral health status
Description
improvement of oral health was measured by oral health index simplified(OHI-S)
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
incidence of oral mucositis
Description
incidence of mucositis due to Who criteria explored by clinical examination
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pegah Mosannen Mozafari, assistant professor
Organizational Affiliation
Oral and maxilloifacial diseases research center of Mashhad university of medical sciences
Official's Role
Study Director
Facility Information:
Facility Name
Oral Medicine Department of Mashhad dental School,Oral and Maxillofacial diseases research center
City
Mashhad
State/Province
Khorasan Razavi
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Effect of Supragingival Irrigators Containing Chlorhexidine on Oral Health in Blood Dyscrasia
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