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

COMPARISON OF PATIENT SATISFACTION AND DIMENSIONAL ACCURACY OF INJECTION MOLDED PEEK AND BRE-FLEX MATERIALS FOR BOUNDED REMOVABLE PARTIAL DENTURES (Randomized Clinical Trial)

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

Study Overview

• Status: Unknown
• Conditions: Patient Satisfaction
• Intervention / Treatment: Other: Bre.flex; Other: PEEK

Detailed Description

The assessor is responsible for all clinical procedure that will be conducted in this study during all the visits:

Panoramic radiograph and periapical radiographs will be made on the prospected abutment teeth to evaluate the crown-root ratio, the apical condition of the abutment and their alveolar bone support.

The preliminary impression will be performed with irreversible hydro-colloid impression material (alginate), The impressions will be poured with type IV dental stone to obtain diagnostic casts. Maxillary Face-bow will be recorded. The diagnostic casts will be mounted on semi adjustable articulator in centric occluding relation to evaluate the interarch distance and occlusal plane.

Special trays will be constructed and Mouth preparation will be performed by preparing guiding planes and rests seats will be prepared opposing to the edentulous area. Final impression will be taken by elastomeric impression material. The impression will be poured into type IV dental stone in order to obtain master cast. The master cast will be surveyed. The proposed design will be as follows: metal framework base saddle for edentulous areas on both sides connected with palatal strap. Aker's clasp on all abutments with buccal retention. The denture base will be tried in with acrylic teeth in patient's mouth. After that, the denture base of the partial denture will be processed incorporation with the metal framework into the two different materials to be evaluated. The first group will receive the partial denture in which the metal framework incorporated with the denture base fabricated from PEEK material. The second group will receive the partial denture in which the metal framework incorporated with the denture base material fabricated from BRE-FLEX.

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• 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.
• 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.

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 Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group 1; patients will receive partial denture constructed from breflex material.	Other: Bre.flex; 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.
Experimental: group 2; patients will receive partial denture constructed from PEEK material.	Other: PEEK; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
dimensional stability	The first week at the time of insertion measuring the dimensional stability immediately after partial denture insertion. The third week measuring the dimensional stability of the partial denture,The fourth week measuring the dimensional stability of the partial denture. dimensional stability is measured by digital caliper.	1 month

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 30, 2017
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): October 1, 2017

Study Registration Dates

• First Submitted: January 12, 2017
• First Submitted That Met QC Criteria: January 17, 2017
• First Posted (Estimate): January 19, 2017

Study Record Updates

• Last Update Posted (Estimate): February 2, 2017
• Last Update Submitted That Met QC Criteria: February 1, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: PEEK; nylon; polyamide; partial denture
• Other Study ID Numbers: 1987 (Diabetes and Endocrinology Research Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided