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CompletedNCT01974401Updated Nov 1, 2013

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

A Phase 2 interventional study of supragingival irrigators containing chlorhexidine in Severe Neutropenia, Thrombocytopenia and Chemotherapy, sponsored by Mashhad University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 12 Years to 60 Years. Per ClinicalTrials.gov, last updated 2013-11-01.

Sponsored by Mashhad University of Medical Sciences · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
12 Years to 60 Years
Sex
All
01

Study 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,..)

Read the 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.

02

Conditions studied

  • Severe Neutropenia
  • Thrombocytopenia
  • Chemotherapy
  • Blood Dyscrasia Patients

Keywords

  • oral irrigator
  • leukemia
  • blood dyscrasia
  • Oral Health Index Simplified (OHI-S)
  • supra gingival irrigator
03

In context

Thrombocytopenia

697 studies on the registry are indexed under Thrombocytopenia; 153 are open to participants now.

This study's enrollment of 20 is below the median of 55 across 472 interventional studies indexed under Thrombocytopenia.

Browse Thrombocytopenia studies →

Lead sponsor

Mashhad University of Medical Sciences is the lead sponsor of 90 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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

05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    water jet irrigator

    patients used supra-gingival irrigators as an oral health measure

    Device: supragingival irrigators containing chlorhexidine

  • No intervention
    control group

    patients in this group received routine oral health care protocols.

Interventions

  • Devicesupragingival 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.

    Also known as: Oral-B Braun Oxyjet irrigators

06

What researchers measure

Primary outcomes

  1. improvement in oral health status

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

    Time frame: 3 weeks

Secondary outcomes

  1. incidence of oral mucositis

    incidence of mucositis due to Who criteria explored by clinical examination

    Time frame: 3 weeks

07

Study locations

1 site
  • Oral Medicine Department of Mashhad dental School,Oral and Maxillofacial diseases research center
    Mashhad, Khorasan Razavi, Iran, Islamic Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01974401
Lead sponsor
Mashhad University of Medical Sciences
Responsible party
Pegah Mosannen Mozafari (assistant professor of oral medicine, Mashhad University of Medical Sciences) — Principal investigator
First posted
Nov 1, 2013
Start date
Jan 2010
Primary completion
Mar 2011
Completion
Jun 2012
Last update
Nov 1, 2013

Study contacts

Pegah Mosannen Mozafari, assistant professor
study director · Oral and maxilloifacial diseases research center of Mashhad university of medical sciences

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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