MedDataX Logo

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

NCT ID: NCT01974401

Last Updated: 2013-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Severe Neutropenia Thrombocytopenia Chemotherapy Blood Dyscrasia Patients

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

water jet irrigator

patients used supra-gingival irrigators as an oral health measure

Group Type ACTIVE_COMPARATOR

supragingival irrigators containing chlorhexidine

Intervention Type 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.

control group

patients in this group received routine oral health care protocols.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Oral-B Braun Oxyjet irrigators

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

12 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mashhad University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Pegah Mosannen Mozafari

assistant professor of oral medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pegah Mosannen Mozafari, assistant professor

Role: STUDY_DIRECTOR

Oral and maxilloifacial diseases research center of Mashhad university of medical sciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Mashhad, Khorasan Razavi, Iran

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Iran

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

89462

Identifier Type: -

Identifier Source: org_study_id