Back to resultsPeriodontitis and Upper gi Post-operative Complications
Primary Purpose
Periodontitis, Surgery--Complications
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
periosafe
Sponsored by
About this trial
This is an interventional prevention trial for Periodontitis
Eligibility Criteria
Inclusion Criteria:
- Need for a upper gi surgery
Exclusion Criteria:
-
Sites / Locations
- Helsinki university hospital
Outcomes
Primary Outcome Measures
meaning of periodontitis in post operative complications
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03144973
First Posted
May 3, 2017
Last Updated
August 25, 2020
Sponsor
Helsinki University Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03144973
Brief Title
Periodontitis and Upper gi Post-operative Complications
Official Title
Meaning of Periodontitis in Post-operative Complications After Upper Gastrointestinal Tract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
May 2, 2017 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Surgery--Complications
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All the patients that have upper-gi surgery in our time frame are asked to join in the study
Masking
Care Provider
Masking Description
operating surgeons or surgeons in the surgical ward do not get to know the test result so it won't affect in patient care
Allocation
Non-Randomized
Enrollment
256 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Diagnostic Test
Intervention Name(s)
periosafe
Intervention Description
mouth rinsing quick-test
Primary Outcome Measure Information:
Title
meaning of periodontitis in post operative complications
Description
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.
Time Frame
1 month after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Need for a upper gi surgery
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanna Seppänen, Phd, Dos
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki university hospital
City
Helsinki
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Periodontitis and Upper gi Post-operative Complications
We'll reach out to this number within 24 hrs