The Use of Water Jet for Initial Treatment FOR Peri-Impla... | NCT01509898

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

NCT01509898

Sponsor

Rambam Health Care Campus

Status

Unknown status

Last Update Posted

Sep 29, 2017Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Peri-implantitis

Interventions

Water jet

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 18, 2012Actual

Primary Completion Date

Nov 2018Estimated

Completion Date

Nov 2018Estimated

First Submitted Date

Jan 1, 2012

First Submission Date that Met QC Criteria

Jan 12, 2012

First Posted Date

Jan 13, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 27, 2017

Last Update Posted Date

Sep 29, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
water-Jet	Experimental	use of water jet for 1 month	Device: Water jet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Water jet	Device	use of water jet for a month	water-Jet	silonit water jet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Probing depth	Probing depth around the implant	one month

Secondary Outcomes

Measure	Description	Time Frame
Bleeding on probing	Bleeding on probing (BOP) around the implant	one month

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dr. liran Levin, DMD	Contact	+972502062820		l_levin@rambam.health.gov.il

Overall Officials

Name	Affiliation	Role
Dr. Liran Levin, DMD	Department of periodontology	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rambam Hospital	Recruiting	Haifa			Israel

Condition Browse Module

MeSH Terms

ID	Term
D057873	Peri-Implantitis

Ancestor Terms

ID	Term
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided