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

Primary Purpose

Maxillary Class III Modification I Edentulous Patients

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Bre-flex maxillary partial denture

PEEK maxillary partial denture

About this trial

This is an interventional other trial for Maxillary Class III Modification I Edentulous Patients focused on measuring "Nylon denture base" and "PEEK partial denture"

Eligibility Criteria

45 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Bre-fllex group

PEEK group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03507153

First Posted

March 23, 2018

Last Updated

April 14, 2018

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03507153

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Unknown status

Study Start Date

May 1, 2018 (Anticipated)

Primary Completion Date

August 1, 2018 (Anticipated)

Study Completion Date

September 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Maxillary Class III Modification I Edentulous Patients

Keywords

"Nylon denture base" and "PEEK partial denture"

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Bre-fllex group

Arm Type

Active Comparator

Arm Description

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

Arm Title

PEEK group

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Bre-flex maxillary partial denture

Intervention Description

Partial denture fabricated from Bre.flex material.

Intervention Type

Procedure

Intervention Name(s)

PEEK maxillary partial denture

Intervention Description

Partial denture fabricated from PEEK material.

Primary Outcome Measure Information:

Title

Muscular activity

Description

Time Frame

one month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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