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Microbial Profile Among Patients Before and After Partial Maxillectomy

R

Rambam Health Care Campus

Status

Unknown

Conditions

Microbiology, Maxilla

Treatments

Diagnostic Test: Microbial profile

Study type

Interventional

Funder types

Other

Identifiers

NCT03390699
0259-17-RMB CTIL

Details and patient eligibility

About

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.

Full description

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.

Enrollment

15 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

before and after partial maxillectomy
Experimental group
Description:
Microbial profile among patients before and after partial maxillectomy
Treatment:
Diagnostic Test: Microbial profile

Trial contacts and locations

0

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Central trial contact

Ilan Hirsh, DMD; Zvi Gutmacher, DMD

Data sourced from clinicaltrials.gov

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