Patient Satisfaction and Dimensional Accuracy of Bre Flex and Peek for Removable Partial Dentures

NCT03025555 | Unknown DMC

• 1 other identifier: 1987
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

Evaluation the patient satisfaction and dimensional stability of upper removable partial denture constructed from two different flexible thermoplastic materials.(BRE-FLEX and PEEK).

Conditions

Patient Satisfaction

Keywords

nylon; polyamide; PEEK; partial denture

Outcome Measures

Primary Outcomes (1)

• patient satisfaction

  The first week at the time of insertion measuring patient satisfaction immediately after partial denture insertion, The third week measuring patient satisfaction of the partial denture, The fourth week measuring patient satisfaction of the partial denture. the patient satisfaction is measured by questionnaire.

  1 month

Secondary Outcomes (1)

• dimensional stability

  1 month

Study Arms (2)

group 1

ACTIVE COMPARATOR

patients will receive partial denture constructed from breflex material.

Other: Bre.flex

group 2

EXPERIMENTAL

patients will receive partial denture constructed from PEEK material.

Other: PEEK

Interventions

PEEK OTHER

Polyetheretherketone (PEEK) is a synthetic, tooth colored polymeric material that has been used as a biomaterial in orthopedics for many years but recently used as removable prosthetic material. Advantages of this polymer material are elimination of allergic reactions, high polishing qualities, low plaque affinity, and good wear resistance. It has been proven that it shows high mechanical and biological properties. Studies evaluating the properties of this material are limited and need more clinical tests.

group 2

Bre.flex OTHER

Bre.flex is a nylon-based thermoplastic material, composed of nylon PA 12 (polyamide).Nylon exhibits high physical strength, heat resistance and chemical resistance. It can be easily modified to increase stiffness and wear resistance. Nylon resin can be semi-translucent and provides excellent esthetics but it is a little more difficult to adjust and polish.

group 1

Eligibility Criteria

• Age: 45 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Male or female patient with age range (45-55) and in good medical condition
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Patient Satisfaction

Interventions

polyetheretherketone

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: January 19, 2017
• Study Start: March 30, 2017
• Primary Completion: August 1, 2017
• Study Completion: October 1, 2017
• Last Updated: February 2, 2017

Record last verified: 2017-02