Peri-implantitisNCT01509898
The Use of Water Jet for Initial Treatment FOR Peri-Implant Disease
A study testing Water jet in people with Peri-implantitis, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
The aim of this study was to evaluate the effect of a dental water jet on initial peri-implant disease resolution. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peri-implantitis
- What is being tested?
- Water jet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- 18 Jul 2012to Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated Informed Consent Form.
- Patient suffer from peri- implant disease
- Age Eligible for study: 18 year old and older
- Genders Eligible for study: Both
Who cannot join
- Patient substantially fails to comply with the study schedule, or treatment program as described in this Protocol.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rambam Hospital
Haifa
Dr. Liran levin, DMD, 972, l_levin@rambam.health.gov.il
About this study
The aim of this study was to evaluate the effect of a dental water jet on initial peri-implant disease resolution.
Read the detailed description
Peri-implant disease is becoming more frequent during the last decade. Till today, there is no effective evidence-based treatment. The use of water-jet might improve those situations and reduce morbidity and implant loss.
- Conditions
- Peri-implantitis
- Being tested
- Water jet
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water jetDevice
Also called silonit water jet
use of water jet for a month
| Study group | Role | What they receive |
|---|---|---|
| water-Jet | Experimental | use of water jet for 1 month Receives: Device: Water jet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing depth
Probing depth around the implant
Measured: one month
Secondary outcomes (1)
Bleeding on probing
Bleeding on probing (BOP) around the implant
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2012 (estimated)
- Study start18 Jul 2012
- Primary completionNov 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implantitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Liran Levin, DMD, Study director, Department of periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509898
- Sponsor's protocol ID
- 0374-11-RMB
- Status last verified
- Sep 2017
- First submitted
- 1 Jan 2012
- Last updated
- 29 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Water Jet for Initial Treatment FOR Peri-Implant Disease
- ClinicalTrials.gov ID
- NCT01509898
- Acronym / sponsor ID
- 0374-11-RMB
- Conditions
- Peri-implantitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 18 Jul 2012 (actual)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 13 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to evaluate the effect of a dental water jet on initial peri-implant disease resolution.
Detailed description
Peri-implant disease is becoming more frequent during the last decade. Till today, there is no effective evidence-based treatment. The use of water-jet might improve those situations and reduce morbidity and implant loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| water-Jet | Experimental | Device: Water jetuse of water jet for 1 month |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed and dated Informed Consent Form.
- Patient suffer from peri- implant disease
- Age Eligible for study: 18 year old and older
- Genders Eligible for study: Both
Key exclusion criteria (1 listed)
- Patient substantially fails to comply with the study schedule, or treatment program as described in this Protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water jetAlso: silonit water jetuse of water jet for a month | Device | water-Jet |
Primary outcome
Probing depth
Time frame: one month
Probing depth around the implant
1 secondary outcome
Bleeding on probing
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Liran Levin, DMD study director
Department of periodontology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water jet in people with Peri-implantitis, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. liran Levin, DMD (+972502062820, l_levin@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing depth (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2017.