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The Use of Water Jet for Initial Treatment FOR Peri-Implant Disease

Primary Purpose

Peri-implantitis

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Water jet
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-implantitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patient substantially fails to comply with the study schedule, or treatment program as described in this Protocol.

Sites / Locations

  • Rambam HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

water-Jet

Arm Description

use of water jet for 1 month

Outcomes

Primary Outcome Measures

Probing depth
Probing depth around the implant

Secondary Outcome Measures

Bleeding on probing
Bleeding on probing (BOP) around the implant

Full Information

First Posted
January 1, 2012
Last Updated
September 27, 2017
Sponsor
Rambam Health Care Campus
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1. Study Identification

Unique Protocol Identification Number
NCT01509898
Brief Title
The Use of Water Jet for Initial Treatment FOR Peri-Implant Disease
Official Title
The Use of Water Jet for Initial Treatment FOR Peri-Implant Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 18, 2012 (Actual)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
November 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rambam Health Care Campus

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-implantitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
water-Jet
Arm Type
Experimental
Arm Description
use of water jet for 1 month
Intervention Type
Device
Intervention Name(s)
Water jet
Other Intervention Name(s)
silonit water jet
Intervention Description
use of water jet for a month
Primary Outcome Measure Information:
Title
Probing depth
Description
Probing depth around the implant
Time Frame
one month
Secondary Outcome Measure Information:
Title
Bleeding on probing
Description
Bleeding on probing (BOP) around the implant
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Patient substantially fails to comply with the study schedule, or treatment program as described in this Protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. liran Levin, DMD
Phone
+972502062820
Email
l_levin@rambam.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Liran Levin, DMD
Organizational Affiliation
Department of periodontology
Official's Role
Study Director
Facility Information:
Facility Name
Rambam Hospital
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Liran levin, DMD
Phone
972
Email
l_levin@rambam.health.gov.il

12. IPD Sharing Statement

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The Use of Water Jet for Initial Treatment FOR Peri-Implant Disease

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