Microbiome Shift in Peri-mucositis by Anti-inflammatory Drugs
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|ClinicalTrials.gov Identifier: NCT03090009|
Recruitment Status : Not yet recruiting
First Posted : March 24, 2017
Last Update Posted : March 31, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Peri-implant Mucositis||Drug: Flurbiprofen Drug: Placebo Oral Tablet||Early Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The study design is random controlled double blind clinical trial|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Both patient and investigator will blinded to the identity of the medication given.|
|Official Title:||The Use of Non-Steroidal Anti-Inflammatory Drugs as a Tool of Positive Change in Peri-Implants Mucositis Microbiome|
|Estimated Study Start Date :||April 2017|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2020|
Active Comparator: Flurbiprofen
Flurbiprofen 100 mg bid.
100 mg twice a day for 14 days
Placebo Comparator: Placebo
Placebo taken bid
Drug: Placebo Oral Tablet
Other Name: Placebo
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090009
|Contact: David Polak, DMD PhDfirstname.lastname@example.org|
|Contact: Aron J Saffer, DDS MSemail@example.com|
|Hadassah Medical Organization||Not yet recruiting|
|Principal Investigator:||David Polak, DMD PhD||Hadassah Medical Organization|