Microbial Profile Among Patients Before and After Partial Maxillectomy

Not Applicable

• Conditions: Microbiology, Maxilla
• Interventions: Diagnostic Test: Microbial profile

• Registration Number: NCT03390699
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

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

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.

Study Timeline

• Status Verified: 2017-12
• Study First Submitted: 2017-12-28
• Study Start: 2018-01
• Primary Completion: 2018-01
• Study First Submitted QC: 2018-01-03
• Last Update Submitted: 2018-01-03
• Study First Posted: 2018-01-04
• Last Update Posted: 2018-01-04
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
before and after partial maxillectomy	Microbial profile	Microbial profile among patients before and after partial maxillectomy

Primary Outcome Measures

Name	Time	Method
microbial types	6 months	types of microbes on the sliva