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

October 26, 2013 updated by: Pegah Mosannen Mozafari, Mashhad University of Medical Sciences

Effect of Using Supragingival Irrigators Containing Chlorhexidine on Oral Health in Patients With 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,..)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: water jet irrigator
patients used supra-gingival irrigators as an oral health measure
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.
Other Names:
  • Oral-B Braun Oxyjet irrigators
No Intervention: control group
patients in this group received routine oral health care protocols.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
improvement in oral health status
Time Frame: 3 weeks
improvement of oral health was measured by oral health index simplified(OHI-S)
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of oral mucositis
Time Frame: 3 weeks
incidence of mucositis due to Who criteria explored by clinical examination
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mashhad University of Medical Sciences

Investigators

  • Study Director: Pegah Mosannen Mozafari, assistant professor, Oral and maxilloifacial diseases research center of Mashhad university of medical sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

October 26, 2013

First Submitted That Met QC Criteria

October 26, 2013

First Posted (Estimate)

November 1, 2013

Study Record Updates

Last Update Posted (Estimate)

November 1, 2013

Last Update Submitted That Met QC Criteria

October 26, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 89462

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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