Microbial Profile Among Patients Before and After Partial Maxillectomy

NCT ID: NCT03390699

Last Updated: 2018-01-04

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-31

Study Completion Date

2018-03-31

Brief Summary

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Patients after maxillecotmy develop gum disease and teeth decay often. these two diseases are caused by bacteria. In addition, these patients may have oral infections such as candida . The therapeutic approach now days to these diseases (dental decay and periodontal disease) can change following the results of the study.

the purpose of the study is to examine whether the connection between the oral cavity and anatomical structures exposed by maxillectomy procedure causes a change in the level of microbes examined. To the best of our knowledge, there are not yet studies examined the clinical and microbiological changes in the oral cavity before and after surgery.

Detailed Description

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This study will include 15 patients who are scheduled to undergo partial maxillectomy as part of a prescribed treatment program prior to their eligibility for the study. The patients will undergo the surgery at the Department of Otolaryngology or Oral and Maxillofacial Surgery and will be given an obturator during surgery by a physician from the Internal and Maxillofacial Rehabilitation Department of the School of Dentistry .

demographic data on the patient's age and gender, general medical history, smoking habits, oral and periodontal and clinical examination (presence of periodontal disease) and microbiological testing will be preformed.

Conditions

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Microbiology, Maxilla

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Microbial profile among patients before partial maxillectomy
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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before and after partial maxillectomy

Microbial profile among patients before and after partial maxillectomy

Group Type EXPERIMENTAL

Microbial profile

Intervention Type DIAGNOSTIC_TEST

microbiological testing

Interventions

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Microbial profile

microbiological testing

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. signed Consent form
2. Patients who are supposed to undergo Maxilla removal without closing the defect using a tissue implant and will need to complete the missing area by an obturator.
3. Men and women aged 18 and over

Exclusion Criteria

1. Allergy to substances from which the obturator is made.
2. Pregnant women
3. Taking antibiotic drugs that affect bacterial flora 4 weeks before taking the saliva sample.
4. Psychiatric problem
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zvi Gutmacher, DMD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Central Contacts

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Zvi Gutmacher, DMD

Role: CONTACT

972-47772983

Ilan Hirsh, DMD

Role: CONTACT

972-47772983

Other Identifiers

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0259-17-RMB CTIL

Identifier Type: -

Identifier Source: org_study_id

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