NCT03090009

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Apr 2017

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 24, 2017

Completed
8 days until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

March 31, 2017

Status Verified

March 1, 2017

Enrollment Period

2 years

First QC Date

March 2, 2017

Last Update Submit

March 30, 2017

Conditions

Peri-implant Mucositis

Keywords

Peri-implant MucositisNSAIDMicrobiome16s Ribosomal Pyro-sequencing

Outcome Measures

Primary Outcomes (1)

  • Change in the Microbiome

    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.

    28 days

Secondary Outcomes (3)

  • change in periodontal probing depth

    28 days

  • change in bleeding on probing

    28 days

  • change in Suppuration

    28 days

Study Arms (2)

Flurbiprofen

ACTIVE COMPARATOR

Flurbiprofen 100 mg bid.

Drug: Flurbiprofen

Placebo

PLACEBO COMPARATOR

Placebo taken bid

Drug: Placebo Oral Tablet

Interventions

FlurbiprofenDRUG

100 mg twice a day for 14 days

Also known as: Ansaid, Strepfen, Ocufen
Flurbiprofen
Placebo Oral TabletDRUG

placebo group

Also known as: Placebo
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinical diagnosis of Peri-implant Mucositis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

Related Publications (2)

  • Paquette DW, Williams RC. Modulation of host inflammatory mediators as a treatment strategy for periodontal diseases. Periodontol 2000. 2000 Oct;24:239-52. doi: 10.1034/j.1600-0757.2000.2240112.x.

    PMID: 11276870BACKGROUND

  • Jeffcoat MK, Reddy MS, Wang IC, Meuninghoff LA, Farmer JB, Koth DL. The effect of systemic flurbiprofen on bone supporting dental implants. J Am Dent Assoc. 1995 Mar;126(3):305-11; quiz 346-7. doi: 10.14219/jada.archive.1995.0173.

    PMID: 7646652BACKGROUND

MeSH Terms

Interventions

Flurbiprofenstrepfen

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsBiphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • David Polak, DMD PhD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Polak, DMD PhD

CONTACT

972-2-6777826polak@mail.huji.ac.il

Aron J Saffer, DDS MS

CONTACT

972-544481897dr-sapir@jerusalemperio.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Both patient and investigator will blinded to the identity of the medication given.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: The study design is random controlled double blind clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 2, 2017

First Posted

March 24, 2017

Study Start

April 1, 2017

Primary Completion

April 1, 2019

Study Completion

April 1, 2020

Last Updated

March 31, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)