Ball and Socket Versus Locator Attachment Retained Implan... | NCT03930862

Studies
Ball and Socket Versus Locator Attachment Retained Implant Overdentures

NCT03930862

Sponsor

Lamees Hosam Ramadan

Status

Unknown status

Last Update Posted

May 1, 2019Actual

Enrollment

12Estimated

Phase

Not Applicable

Conditions

Complete Edentulism

Interventions

Locator Attachment (positioner)

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

Apr 2019

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

Sep 15, 2019Estimated

Primary Completion Date

Oct 1, 2020Estimated

Completion Date

Oct 1, 2020Estimated

First Submitted Date

Apr 5, 2019

First Submission Date that Met QC Criteria

Apr 26, 2019

First Posted Date

Apr 29, 2019Actual

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

Apr 29, 2019

Last Update Posted Date

May 1, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Will the use of locator attachment influence the muscle efficacy when compared to ball and socket attachment in mandibular implant overdenture? '

Detailed Description

In this study we will use a two different types of attachments in implants overdenture in mandibular completely edentulous patients to increase the retention and stability of the denture and this can be recognized by record the masticatory function of the muscles of the mandibular jaw.

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

12Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ball and socket	Active Comparator	It is an attachment retaining implant overdentures to increase retention and stability of the denture	Device: Locator Attachment (positioner)
Locator attachment	Experimental	attachment retaining implant overdentures	Device: Locator Attachment (positioner)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Locator Attachment (positioner)	Device	intra oral attachment	Locator attachment ball and socket

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Muscle Activity	Digital Electromyogram	6 month

Secondary Outcomes

Measure	Description	Time Frame
Patient Satisfaction: questionnaire	questionnaire from zero to 10 where zero is completely unsatisfied and 10 is highly satisfied	6 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Upper and lower completely edentulous patients. Acceptance of the existing denture if it is good, or constructing a new one if it is defected.

Patients with adequate bone quality and quantity. Tooth extracted not less than 6 month.

Exclusion Criteria:

Young patients.
Diseases affecting neuromuscular coordination.
TMJ diseases.
Soft tissue abnormalities.
Bony exostosis.
Parathyroid dysfunction
uncontrolled Diabetes
Radiotherapy to the neck or head
Pregnancy.
Drug and alcohol dependency.
Smokers.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lamees Hosame, Master	Contact	020-1020111367		Lamees_bota@hotmail.com

Overall Officials

Name	Affiliation	Role
Nada Sherine, PhD	Lecturer of Prosthdontics	Study Director

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided