Retention of Peek and Bre.Flex Materials Maxillary Bilateral Bounded Removable Partial Dentures

NCT03025568 | Unknown DMC

• 1 other identifier: 1989
• Study Type: interventional
• Target: 17
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Retention

Keywords

nylon; polyamide; denture base

Outcome Measures

Primary Outcomes (1)

• Evaluation of Retention of removable partial denture constructed from PEEK and Bre-flex

  The first week, at the time of insertion measuring Retention immediately after partial denture insertion,The third week measuring Retention of the partial denture, The fourth week measuring Retention of the partial denture. retention is measured by digital force gauge device.

  One month

Study Arms (2)

group 1

ACTIVE COMPARATOR

Patient will receive partial denture constructed from Bre\_flex

Other: Bre.flex

group 2

EXPERIMENTAL

Patients will receive removable partial denture constructed from PEEK

Other: PEEK

Interventions

PEEK OTHER

PEEK (poly-ether-ether-ketone) has been successfully used over the last years in the medical field, and orthopedics, specifically. which presents high biocompatibility, good mechanical properties, high temperature resistance, and chemical stability due to a 4 GPa modulus of elasticity, it is as elastic as bone and can reduce stresses transferred to the abutment teeth. Additional advantages of this polymer material are elimination of allergic reactions and metallic taste, high polishing qualities, low plaque affinity, and good wear resistance, it has only recently been used in dentistry.

group 2

Bre.flex OTHER

In the recent time thermoplastic materials (breflex) become quite popular in clinical practice such as nylon and acetal resins. since the 1950, polyamide resin (nylons) provide improved esthetics and reduction of rotational forces on the abutment teeth due to their low elastic modulus.

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

Interventions

polyetheretherketone

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• 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 1, 2017
• Primary Completion: August 1, 2017
• Study Completion: October 1, 2017
• Last Updated: January 19, 2017

Record last verified: 2017-01