(PEEK) Housing Verses Metallic Housing of Ball and Socket... | NCT02950662

Studies
(PEEK) Housing Verses Metallic Housing of Ball and Socket Attachment on Retention of Mandibular Overdenture

NCT02950662

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Nov 1, 2016Estimated

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Problem With Dentures

Interventions

Overdenture

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

Oct 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016

Primary Completion Date

Dec 2017Estimated

Completion Date

Not provided

First Submitted Date

Oct 25, 2016

First Submission Date that Met QC Criteria

Oct 31, 2016

First Posted Date

Nov 1, 2016Estimated

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

Oct 31, 2016

Last Update Posted Date

Nov 1, 2016Estimated

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

The aim of this study is to compare the clinical effect of PEEK housing vs. metal housing in terms of retention and patient satisfaction

Detailed Description

Not provided

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

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Metal housing	Active Comparator	metal housing of ball and socket attachment the intervention will be overdenture	Other: Overdenture
Peek housing	Active Comparator	Peek housing of ball and socket attachment the intervention will be overdenture	Other: Overdenture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Overdenture	Other	Active comparator will be metal housing and peek housing	Metal housing Peek housing

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Retention of implant supported overdenture by using digital force meter device		3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient should be free from any systemic disease that may interfere with dental implants placement and/or osseointegration e.g. uncontrolled diabetes, hypertension, blood diseases, bone diseases, smoking.etc.
Patients have completely edentulous upper and lower arches.
Patients have healthy mucosa free from any ulceration, inflammation or infections.
All patients are free from neuromuscular and temporomandibular joint disorders.
Selected patients have normal maxillo-mandibular relationship (Angle class I ridge classification) with adequate inter-arch space and normal tongue size.

Exclusion Criteria:

Patients with limited manual dexterity.
Patients with Xerostomia, excessive salivation or pathological mucosal changes (e.g. Lichen planus, Leukoplakia…etc.)
Pregnant females.
Un co-operative patients.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

60 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

Intervention Browse Module

MeSH Terms

ID	Term
D003828	Denture, Overlay

Ancestor Terms

ID	Term
D003778	Dentures
D017266	Dental Prosthesis
D011476	Prosthodontics
D003813	Dentistry

Browse Leaves

Not provided

Browse Branches

Not provided