Ball and Socket Versus Locator Attachment Retained Implant Overdentures

NCT ID: NCT03930862

Last Updated: 2019-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-15

Study Completion Date

2020-10-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Complete Edentulism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ball and socket

It is an attachment retaining implant overdentures to increase retention and stability of the denture

Group Type ACTIVE_COMPARATOR

Locator Attachment (positioner)

Intervention Type DEVICE

intra oral attachment

Locator attachment

attachment retaining implant overdentures

Group Type EXPERIMENTAL

Locator Attachment (positioner)

Intervention Type DEVICE

intra oral attachment

Interventions

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Locator Attachment (positioner)

intra oral attachment

Intervention Type DEVICE

Eligibility Criteria

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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

1. Young patients.
2. Diseases affecting neuromuscular coordination.
3. TMJ diseases.
4. Soft tissue abnormalities.
5. Bony exostosis.
6. Parathyroid dysfunction
7. uncontrolled Diabetes
8. Radiotherapy to the neck or head
9. Pregnancy.
10. Drug and alcohol dependency.
11. Smokers.
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lamees Hosam Ramadan

OTHER

Sponsor Role lead

Responsible Party

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Lamees Hosam Ramadan

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Nada Sherine, PhD

Role: STUDY_DIRECTOR

Lecturer of Prosthdontics

Central Contacts

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Lamees Hosame, Master

Role: CONTACT

020-1020111367

Other Identifiers

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Muscle activity

Identifier Type: -

Identifier Source: org_study_id

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