The aim of this study is to assess the effectivity of the Fluxion, in combination with Bluem (Bluem, Bluem Europe, Zwolle, The Netherlands) and in combination with demineralised water. This aims to find a minimally invasive treatment for peri-…
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Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Peri-implant probing depth (PPD) is the primary parameter.
Secondary outcome
Secondary parameters include the amount of active metalloproteinase-8 proteins
(MMP-8), color of the gingiva, plaque by the modified plaque index (MPI), BOP,
suppuration, swelling and radiographical bone height in mm. Finally, the
participant is asked to indicate the degree of pain during treatment on a
numerical scale from 1 (no pain) to 10 (most possible pain). In addition, the
following data is collected: gender, age, presence or absence of natural
elements, the location of the implants and whether or not to smoke.
Background summary
Peri-implantitis is a common issue within the field of dental implantology.
Despite decades of research on peri-implantitis treatments, no consensus is
achieved on which treatment is most succesful. Recently, the Fluxion was
launched onto the market. This device could treat peri-implantitis, using
pocket-irrigation which is achieved by alternating vacuum and liquid infusion
into the pocket. In previous research, the Fluxion is tested in combination
with demineralised water as the liquid. Using an antimicrobial liquid instead
of water could increase the effectivity of the Fluxion.
Study objective
The aim of this study is to assess the effectivity of the Fluxion, in
combination with Bluem (Bluem, Bluem Europe, Zwolle, The Netherlands) and in
combination with demineralised water. This aims to find a minimally invasive
treatment for peri-implantitis.
Study design
The study is a randomised controlled trial in which 60 participants with a
total of 60 implants (maximum of one implant per participant) will be randomly
divided over the following three groups:
Experiment group 1: Fluxion + demineralised water
Experiment group 2: Fluxion + Bluem
Control group: conventional treatment using airflow (EMS AIRFLOW HANDY 3.0,
EMS, Nyon, Swiss)
Prior to and six weeks after treatment respectively baseline and follow-up
measurements of the clinical inflammatory parameters will take place.
Radiographical bonelevels will be assessed at baseline and six months after
therapy. The research will take place at Lassus Tandartsen Oisterwijk.
Intervention
The therapy in groups 1 and 2 consists of treatment of the implants with the
Fluxion. The Fluxion is a box-like apparatus consisting of two compartments:
one compartiment carrying the fluid which is used for infusion, and one
compartiment in which the extracted matter ends up. A hose is connected to the
box on one side, while on the other side a tip is attached to it. This tip is
placed on the junction from the gingiva to the crown or to the implant in 6
sites, three buccal and three lingual or palatal. At each site, rapid
alternations of fluid infusion and vacuum will take place for 7 seconds (one
cycle). Demineralized water is used as a liquid for the participants from group
1 and Bluem for participants from group 2.
The participants from the control group are treated with airflow. Erythritol
(AIR-FLOW PLUS, EMS, Nyon, Swiss) is used as the powder in the airflow, which
is applied as standard.
Study burden and risks
Participants attend the practice three times. At the first appointment, the
baseline measurement (clinical and radiographic) and the treatment are
performed (20 min), at the second treatment the follow-up measurement of the
clinical parameters (5 min) and at the third appointment the second X-ray is
taken (5 min. ). The research setting differs minimally from the regular care
for peri-implantitis patients, only the third appointment for a second X-ray is
the extra burden that participants undergo.
The three treatments are minimally invasive and previous research has shown no
risks with treatment with the Fluxion and the airflow.
Antonius Deusinglaan 1
Groningen 9713 AV
NL
Antonius Deusinglaan 1
Groningen 9713 AV
NL
Listed location countries
Age
Inclusion criteria
radiographical boneloss >= 2 mm surrounding an implant
presence of bleeding on probing or suppuration
age of at least 18 years old
Exclusion criteria
uncontrolled diabetes mellitus
usage of prescripted anti-inflammatory medication
presence of an allergic reaction to chlorhexidine
pregnancy
in case of an antibiotics therapy in the last 6 months
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL75381.042.21 |