Microbiology, MaxillaNCT03390699
Microbial Profile Among Patients Before and After Partial Maxillectomy
A study testing Microbial profile in people with Microbiology, Maxilla, run by Rambam Health Care Campus.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Microbiology, Maxilla
- What is being tested?
- Microbial profile
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Jan 2018to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- signed Consent form
- 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.
- Men and women aged 18 and over
Who cannot join
- Allergy to substances from which the obturator is made.
- Pregnant women
- Taking antibiotic drugs that affect bacterial flora 4 weeks before taking the saliva sample.
- Psychiatric problem
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Microbial Profile Among Patients Before and After Partial Maxillectomy
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.
Read the 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.
- Conditions
- Microbiology, Maxilla
- Being tested
- Microbial profile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbial profileDiagnostic test
microbiological testing
| Study group | Role | What they receive |
|---|---|---|
| before and after partial maxillectomy | Experimental | Microbial profile among patients before and after partial maxillectomy Receives: Diagnostic Test: Microbial profile |
What is being measured
The primary outcome is the main question the study is designed to answer.
microbial types
types of microbes on the sliva
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study startJan 2018 (estimated)
- Primary completionJan 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbiology, MaxillaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Microbial profile among patients before partial maxillectomy
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zvi Gutmacher, DMD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390699
- Sponsor's protocol ID
- 0259-17-RMB CTIL
- Status last verified
- Dec 2017
- First submitted
- 28 Dec 2017
- Last updated
- 4 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Microbial Profile Among Patients Before and After Partial Maxillectomy
- ClinicalTrials.gov ID
- NCT03390699
- Acronym / sponsor ID
- 0259-17-RMB CTIL
- Conditions
- Microbiology, Maxilla
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Jan 2018 (estimated)
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 4 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Microbial profile among patients before partial maxillectomy
| Arm | Type | Receives |
|---|---|---|
| before and after partial maxillectomy | Experimental | Diagnostic Test: Microbial profileMicrobial profile among patients before and after partial maxillectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- signed Consent form
- 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.
- Men and women aged 18 and over
Key exclusion criteria (4 listed)
- Allergy to substances from which the obturator is made.
- Pregnant women
- Taking antibiotic drugs that affect bacterial flora 4 weeks before taking the saliva sample.
- Psychiatric problem
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microbial profilemicrobiological testing | Diagnostic test | before and after partial maxillectomy |
Primary outcome
microbial types
Time frame: 6 months
types of microbes on the sliva
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2018.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zvi Gutmacher, DMD principal investigator
Rambam Health Care Campus
Questions about this trial
What is this clinical trial studying?
A study testing Microbial profile in people with Microbiology, Maxilla, run by Rambam Health Care Campus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zvi Gutmacher, DMD (972-47772983, z_gutmacher@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microbial types (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2018.