Clinical Trial: Microbiome Shift in Peri-mucositis by Anti-inflammatory Drugs

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: The Use of Non-Steroidal Anti-Inflammatory Drugs as a Tool of Positive Change in Peri-Implants Mucositis Microbiome

Brief Summary:

Dental implants are often used to replace missing teeth. In fact, in the US over 700,000 implants are places every year and over 2 million implants are places world wide. Peri-implant mucositis in an inflammatory condition affecting dental implants and is recognized as a risk factor for peri-implantitis (a condition affecting the bone around implants and eventually leading to implant loss). The prevalence of Peri-implant Mucositis has been reported in the literature to range from 50-90% whereas the prevalence of Peri-implantitis has been reported as high as 20%. it is commonly believed that a dysbiotic microbiome is the primary cause for these conditions.

The inflammatory burden around diseased implants creates a high-protein environment which is necessary for the survival of pathogenic bacteria. It is logical, therefore, that reducing inflammation by Non Steroidal Anti-Inflammatory Drugs (NSAIDs) may create a shift in the dysbiotic microbiome to a symbiotic microbiome. The aim of the current study is to test the effects of oral NSAIDs on the peri-implant microbiome.


Detailed Summary:

Inflammation around dental implants has been defined as Peri-implant mucositis and Peri-implantitis . Peri-implant mucositis is a localized inflammation limited to the mucosal tissue surrounding the implant whereas peri-implantitis has advanced to the bone surrounding the implant as well. The prevalence of Peri-implant Mucositis has been reported in the literature to range from 50-90% whereas the prevalence of Peri-implantitis has been reported as high as 20%. Due to the fact that there are many similarities in the clinical manifestations of infection in the gingiva and peri-implant mucosal tissue, studies attempted to compare the microbial characteristics around teeth to that found around implants. Emerging data suggests that the microbiome around infected teeth has some similarities and dissimilarities to peri-implant infection. Such differences may stem from different inflammatory characteristics as well as the presence of a non-vital foreign material (the dental implant) in the area. Some of the known pathogenic strains identified in the peri-implant sulcus are anaerobic a-saccharolytic bacteria, which feed off the adjacent tissue inflammatory exudate. Logically, attenuation of the inflammation would deprive the nearby bacteria of nourishment needed to sustain their growth.

The use of non-steroidal anti-inflammatory drugs (NSAID) to control chronic inflammatory disease has been used extensively in medicine. Its action of blocking cyclooxygenase inflammatory pathway and in-effect blocking the production of Prostaglandin-E2 (PGE2) has led to its use with general pain control as well as its long term use in the treatment of tissue inflammation and pain caused by rheumatoid arthritis or osteoarthritis, tendinitis and bursitis.

Offenbacher et al. as early as in 1981 discovered that patients with periodontitis had significan
Sponsor: Polak David

Current Primary Outcome: Change in the Microbiome [ Time Frame: 28 days ]

The microbiome profile of the Flurbiprofen group before treatment (base line) and after treatment (day 14) and two weeks post-treatment (day 28) will be compared, as well as the microbiome of the placebo group. data will be pooled and analysed as absolute number of any microbe within the tested biofilms. Measures of change will be set as 14d vs. baseline and 28 day vs. baseline.


Original Primary Outcome: Change in the Microbiome [ Time Frame: 28 days ]

The microbiome profile of the Flurbiprofen group before treatment (base line) and after treatment (day 14) and two weeks post-treatment (day 28) will be compared, as well as the microbiome of the placebo group. data will be pooled and analysed as absolute number of any microbe within the tested biofilms.


Current Secondary Outcome:

  • change in periodontal probing depth [ Time Frame: 28 days ]
    change in probing sulcular depth around implants
  • change in bleeding on probing [ Time Frame: 28 days ]
    change in bleeding on probing in the peri-implant sulcus
  • change in Suppuration [ Time Frame: 28 days ]
    change in presence or absence in the peri-implant sulcus


Original Secondary Outcome: Same as current

Information By: Hadassah Medical Organization

Dates:
Date Received: March 2, 2017
Date Started: April 2017
Date Completion: April 2020
Last Updated: March 30, 2017
Last Verified: March 2017