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Microbiome Shift in Peri-mucositis by Anti-inflammatory Drugs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03090009
Recruitment Status : Not yet recruiting
First Posted : March 24, 2017
Last Update Posted : March 31, 2017
Information provided by (Responsible Party):
Polak David, Hadassah Medical Organization

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.

Condition or disease Intervention/treatment Phase
Peri-implant Mucositis Drug: Flurbiprofen Drug: Placebo Oral Tablet Early Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
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.
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Flurbiprofen
Flurbiprofen 100 mg bid.
Drug: Flurbiprofen
100 mg twice a day for 14 days
Other Names:
  • Ansaid
  • Strepfen
  • Ocufen

Placebo Comparator: Placebo
Placebo taken bid
Drug: Placebo Oral Tablet
placebo group
Other Name: Placebo

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. change in periodontal probing depth [ Time Frame: 28 days ]
    change in probing sulcular depth around implants

  2. change in bleeding on probing [ Time Frame: 28 days ]
    change in bleeding on probing in the peri-implant sulcus

  3. change in Suppuration [ Time Frame: 28 days ]
    change in presence or absence in the peri-implant sulcus

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • clinical diagnosis of Peri-implant Mucositis

Exclusion Criteria:

  • hypersensitivity to or intolerance of Flurbiprofen or NSAIDs
  • peptic ulcer
  • pregnancy
  • smoking
  • diabetes mellitus
  • having taken any antibiotic drug within the previous 6 weeks

Information from the National Library of Medicine

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 identifier (NCT number): NCT03090009

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Contact: David Polak, DMD PhD 972-2-6777826
Contact: Aron J Saffer, DDS MS 972-544481897

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Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel
Sponsors and Collaborators
Polak David
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Principal Investigator: David Polak, DMD PhD Hadassah Medical Organization

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Responsible Party: Polak David, Principal Investigator, Hadassah Medical Organization Identifier: NCT03090009     History of Changes
Other Study ID Numbers: 0674-16-HMO
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Polak David, Hadassah Medical Organization:
Peri-implant Mucositis
16s Ribosomal Pyro-sequencing
Additional relevant MeSH terms:
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Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Inflammatory Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action