Periodontitis and Upper gi Post-operative Complications

August 25, 2020 updated by: Tiina Vuorela, Helsinki University Central Hospital

Meaning of Periodontitis in Post-operative Complications After Upper Gastrointestinal Tract Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

256

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland
        • Helsinki University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Need for a upper gi surgery

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
meaning of periodontitis in post operative complications
Time Frame: 1 month after surgery
Periodontitis is being tested by Periosafe (c) quick-test. Participants with positive results on the test have periodontitis. Participants patient data is being analyzed after surgery and is compared to periodontitis results. The correlation between periodontitis and surgical complications is subject to analysis.
1 month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Investigators

  • Principal Investigator: Hanna Seppänen, Phd, Dos, Helsinki University Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2017

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

May 3, 2017

First Submitted That Met QC Criteria

May 4, 2017

First Posted (Actual)

May 9, 2017

Study Record Updates

Last Update Posted (Actual)

August 26, 2020

Last Update Submitted That Met QC Criteria

August 25, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUS/269/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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