Microbial Adhesion to Metallic Versus Non Metallic Surfac... | NCT03008317

Studies
Microbial Adhesion to Metallic Versus Non Metallic Surfaces of Bounded Removable Partial Denture

NCT03008317

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Jan 2, 2017Estimated

Enrollment

2Estimated

Phase

Not Applicable

Conditions

Polyetheretherketone

Interventions

PEEK

Countries

Not provided

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

Dec 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016

Primary Completion Date

Oct 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Dec 20, 2016

First Submission Date that Met QC Criteria

Dec 30, 2016

First Posted Date

Jan 2, 2017Estimated

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

Dec 30, 2016

Last Update Posted Date

Jan 2, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

a split mouth randomized clinical trial that compares quantity and quality of bacterial adhesion under both PEEK versus cobalt chromium alloy denture base.

Detailed Description

this study aimed to compare the adhesion of microorganisms to the non metallic denture base of PEEK and metallic denture base of cobalt chromium alloy in patients with class III modification 1

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

2Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
non metallic	Active Comparator	PEEK denture base,	Device: PEEK
metallic denture base	Placebo Comparator	cobalt chromium alloy denture base	Device: PEEK

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PEEK	Device	a metallic denture base	metallic denture base non metallic

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
microbial culture using number of clonies after insertion by 3 months	microbial adhesion will be measured using continous cultures to assess number of colonies	one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients are medically free

Exclusion Criteria:

patients with badly broken abutments

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided