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NCT Number: NCT01974401

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

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,..)

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Key information

Conditions

Severe Neutropenia Agranulocytosis Blood Dyscrasia Patients Blood Platelet Disorders Chemotherapy Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukocyte Disorders Leukopenia Neoplasms Neoplasms by Histologic Type Neutropenia Thrombocytopenia

Age range

12 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Oral Medicine Department of Mashhad dental School,Oral and Maxillofacial diseases research center

Mashhad, Razavi Khorasan Province, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

supragingival irrigators containing chlorhexidine

Device

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.

Other names: Oral-B Braun Oxyjet irrigators

Primary outcomes

  1. improvement in oral health status

    Time frame: 3 weeks

    improvement of oral health was measured by oral health index simplified(OHI-S)

Secondary outcomes

  1. incidence of oral mucositis

    Time frame: 3 weeks

    incidence of mucositis due to Who criteria explored by clinical examination

Sponsors and collaborators

Lead sponsor

Mashhad University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Nov 1, 2013
Registry last updated
Nov 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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