Periodontitis and Upper gi Post-operative Complications

NCT ID: NCT03144973

Last Updated: 2020-08-26

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

COMPLETED

Clinical Phase

NA

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-02

Study Completion Date

2020-06-30

Brief Summary

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Periodontitis is a infection of mouth gingival mucosa and connecting tissue. It has been shown in previous studies to have a effect on the risk of heart diseases getting worse and elevate risk in heart surgery. The investigators are studying periodontitis and how it affects upper gastrointestinal tract patients complication rates and the quality of complications.

Detailed Description

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Before patricipating patients go to preop, the investigators have them take a mouth rinsing quick-test, periosafe(c), that tells specifically about periodontitis. Participants go to surgery (upper gi) and have a normal operation following our clinics standards and normal follow up. After the investigators analyze the patient data concerning possible complications and do they have relations between the positive periodontitis results. Participants are also given advice about seeing a dentist if positive results are seen, but the operating surgeons do not get to know the mouth rinsing test results.

Conditions

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Periodontitis Surgery--Complications

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

All the patients that have upper-gi surgery in our time frame are asked to join in the study
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers
operating surgeons or surgeons in the surgical ward do not get to know the test result so it won't affect in patient care

Interventions

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periosafe

mouth rinsing quick-test

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Need for a upper gi surgery

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tiina Vuorela

MD, PHD student, Junior surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hanna Seppänen, Phd, Dos

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Locations

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Helsinki university hospital

Helsinki, , Finland

Site Status

Countries

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Finland

Other Identifiers

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HUS/269/2017

Identifier Type: -

Identifier Source: org_study_id

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