Muscle Activity Evaluation of Maxillary Bilateral Bounded Partial Denture Fabricated By Bre-Flex Versus Peek

NCT ID: NCT03507153

Last Updated: 2018-04-24

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2018-09-01

Brief Summary

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Evaluation of the muscle activity of masseter in tooth borne partial denture wearers (class III modification 1 Kennedy's classification) with two different denture base materials (Breflex and PEEK) by means of electromyograph.

Detailed Description

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Conditions

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Maxillary Class III Modification I Edentulous Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Only statistician will be blinded as the 2 materials have different colors The patients: they won't be aware of the lab procedures till finishing and delivery of the dentures.

The outcome assessor: the assessor who will assess the muscular activity will be blinded.

Study Groups

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Bre-fllex group

Maxillary class III modification I edentulous patients that will recieve Bre-flex partial denture

Group Type ACTIVE_COMPARATOR

Bre-flex maxillary partial denture

Intervention Type PROCEDURE

Partial denture fabricated from Bre.flex material.

PEEK group

Maxillary class III modification I edentulous patients that will recieve PEEK partial denture

Group Type EXPERIMENTAL

PEEK maxillary partial denture

Intervention Type PROCEDURE

Partial denture fabricated from PEEK material.

Interventions

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Bre-flex maxillary partial denture

Partial denture fabricated from Bre.flex material.

Intervention Type PROCEDURE

PEEK maxillary partial denture

Partial denture fabricated from PEEK material.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All patients must have Kennedy class III modification I upper partially edentulous ridges.
* The remaining teeth have good periodontal condition, with no signs of attrition or gingival recession.
* All patients have skeletal Angle's class I maxillo-mandibular relationship and have sufficient interarch distance.
* Free from any systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles.
* Free from any tempro-mandibular joint disorder.
* The patients have good oral hygiene and low caries index.

Exclusion Criteria

* Patients having abnormal habits as bruxism or clenching.
* Patients having hormonal disorders as diabetes, thyroid or parathyroid hormonal diseases were not included.
* Teeth with compromised bone support.
* Patient with xerostomia or excessive salivation.
* Patient with abnormal tongue behavior and/or size.
Minimum Eligible Age

45 Years

Maximum Eligible Age

55 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 salama sayed tantawy

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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ASalama

Identifier Type: -

Identifier Source: org_study_id

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