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

Phase 2

Completed

• Conditions: Thrombocytopenia; Chemotherapy; Blood Dyscrasia Patients; Severe Neutropenia
• Interventions: Device: supragingival irrigators containing chlorhexidine

• Registration Number: NCT01974401
• Lead Sponsor: Mashhad University of Medical Sciences

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 Timeline

• Study Start: 2010-01
• Primary Completion: 2011-03
• Study Completion: 2012-06
• Status Verified: 2013-10
• Study First Submitted: 2013-10-26
• Study First Submitted QC: 2013-10-26
• Last Update Submitted: 2013-10-26
• Study First Posted: 2013-11-01
• Last Update Posted: 2013-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
water jet irrigator	supragingival irrigators containing chlorhexidine	patients used supra-gingival irrigators as an oral health measure

Primary Outcome Measures

Name	Time	Method
improvement in oral health status	3 weeks	improvement of oral health was measured by oral health index simplified(OHI-S)

Secondary Outcome Measures

Name	Time	Method
incidence of oral mucositis	3 weeks	incidence of mucositis due to Who criteria explored by clinical examination

Trial Locations

Locations (1)

Oral Medicine Department of Mashhad dental School,Oral and Maxillofacial diseases research center; 🇮🇷 Mashhad, Khorasan Razavi, Iran, Islamic Republic of