Periodontitis and Upper gi Post-operative Complications

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03144973
• Other study ID #: HUS/269/2017
• Status: Completed
• Phase: N/A
• Start date: May 2, 2017
• Est. completion date: June 30, 2020

Study information

• Verified date: August 2020
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Need for a upper gi surgery

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Periodontitis
• Postoperative Complications
• Surgery--Complications

Intervention

Diagnostic Test:
• periosafe
mouth rinsing quick-test

Locations

Country	Name	City	State
Finland	Helsinki university hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month after surgery