NCT03930862

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2019

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 29, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

September 15, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

May 1, 2019

Status Verified

April 1, 2019

Enrollment Period

1 year

First QC Date

April 5, 2019

Last Update Submit

April 29, 2019

Conditions

Complete Edentulism

Outcome Measures

Primary Outcomes (1)

  • Muscle Activity

    Digital Electromyogram

    6 month

Secondary Outcomes (1)

  • Patient Satisfaction: questionnaire

    6 month

Study Arms (2)

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

Locator Attachment (positioner)DEVICE

intra oral attachment

Locator attachmentball and socket

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Nada Sherine, PhD

    Lecturer of Prosthdontics

    STUDY DIRECTOR

Central Study Contacts

Lamees Hosame, Master

CONTACT

020-1020111367Lamees_bota@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 5, 2019

First Posted

April 29, 2019

Study Start

September 15, 2019

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

May 1, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share