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

Thrombocytopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01974401
• Other study ID #: 89462
• Status: Completed
• Phase: Phase 2
• First received: October 26, 2013
• Last updated: October 26, 2013
• Start date: January 2010
• Est. completion date: June 2012

Study information

• Verified date: October 2013
• Source: Mashhad University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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,..)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Blood Dyscrasia Patients
• Chemotherapy
• Hematologic Diseases
• Neutropenia
• Severe Neutropenia
• Thrombocytopenia
• Thrombocytosis

Intervention

Device:
• supragingival irrigators containing chlorhexidine
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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Oral Medicine Department of Mashhad dental School,Oral and Maxillofacial diseases research center	Mashhad	Khorasan Razavi

Sponsors (1)

Lead Sponsor	Collaborator
Mashhad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement in oral health status	improvement of oral health was measured by oral health index simplified(OHI-S)	3 weeks	No
Secondary	incidence of oral mucositis	incidence of mucositis due to Who criteria explored by clinical examination	3 weeks	No