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

NCT ID: NCT02950662

Last Updated: 2016-11-01

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Brief Summary

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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

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Conditions

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Problem With Dentures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Metal housing

metal housing of ball and socket attachment the intervention will be overdenture

Group Type ACTIVE_COMPARATOR

Overdenture

Intervention Type OTHER

Active comparator will be metal housing and peek housing

Peek housing

Peek housing of ball and socket attachment the intervention will be overdenture

Group Type ACTIVE_COMPARATOR

Overdenture

Intervention Type OTHER

Active comparator will be metal housing and peek housing

Interventions

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Overdenture

Active comparator will be metal housing and peek housing

Intervention Type OTHER

Other Intervention Names

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Implant supported overdenture

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. Patients have completely edentulous upper and lower arches.
3. Patients have healthy mucosa free from any ulceration, inflammation or infections.
4. All patients are free from neuromuscular and temporomandibular joint disorders.
5. Selected patients have normal maxillo-mandibular relationship (Angle class I ridge classification) with adequate inter-arch space and normal tongue size.

Exclusion Criteria

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

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Ibrahim Eldesoky Mohamed Elbakry

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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cebd-cu-2016-10-230

Identifier Type: -

Identifier Source: org_study_id