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

Muscle Activity Evaluation of Maxillary Bilateral Bounded Partial Denture Fabricated By Bre-Flex Versus Peek (Randomized Clinical Trial)

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.

Study Overview

• Status: Unknown
• Conditions: Maxillary Class III Modification I Edentulous Patients
• Intervention / Treatment: Procedure: Bre-flex maxillary partial denture; Procedure: PEEK maxillary partial denture

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Bre-fllex group; Maxillary class III modification I edentulous patients that will recieve Bre-flex partial denture	Procedure: Bre-flex maxillary partial denture; Partial denture fabricated from Bre.flex material.
EXPERIMENTAL: PEEK group; Maxillary class III modification I edentulous patients that will recieve PEEK partial denture	Procedure: PEEK maxillary partial denture; Partial denture fabricated from PEEK material.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscular activity	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.	one month

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2018
• Primary Completion (ANTICIPATED): August 1, 2018
• Study Completion (ANTICIPATED): September 1, 2018

Study Registration Dates

• First Submitted: March 23, 2018
• First Submitted That Met QC Criteria: April 14, 2018
• First Posted (ACTUAL): April 24, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 24, 2018
• Last Update Submitted That Met QC Criteria: April 14, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: "Nylon denture base" and "PEEK partial denture"
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: ASalama

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No