Comparative Study of Biting Force of Injection Molded PEEK and Bre.Flex for Removable Partial Dentures.

NCT03038737 | Unknown DMC

• 1 other identifier: 1234
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the present study is to evaluate the biting force of upper removable partial denture constructed from two different flexible thermoplastic materials.

Conditions

Biting

Keywords

nylon; polyamide; PEEK; partial denture

Outcome Measures

Primary Outcomes (1)

• change in Biting force

  the change in biting force will be recorded three times. The first week at the time of insertion measuring the biting force immediately after partial denture insertion. The third week measuring biting force of the partial denture. The fourth week measuring biting force of the partial denture. the biting force will be measured by I-load sensor.

  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

bre.flex OTHER

In the recent time thermoplastic materials 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(3). The major disadvantage of a nylon RDP is the inability for a reline procedure and the lack of occlusal rests as well as rigid frameworks, that could lead to occlusal instability and sinking, especially in Kennedy class I and II cases. On the other hand, acetal resins present adequate mechanical strength to form a frame-work more rigid than nylon with retentive clasps, connectors, and supportive elements; however, the acetal resin material lacks natural translucency and vitality.

group 1

PEEK OTHER

PEEK 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

Eligibility Criteria

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

You may qualify if:

• i. All patients must have Kennedy class III modification I upper partially edentulous ridges.
• ii. The remaining teeth have good periodontal condition, with no signs of attrition or gingival recession.
• iii. Male or female patient with age range (45-55) and in good medical condition iv. All patients have skeletal Angle's class I maxillo-mandibular relationship and have sufficient interarch distance.
• v. Free from any systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles.
• vi. Free from any tempro-mandibular joint disorder. vii. The patients have good oral hygiene and low caries index.

You may not qualify if:

• i. Patients having abnormal habits as bruxism or clenching ii. Patients having hormonal disorders as diabetes, thyroid or parathyroid hormonal diseases were not included.
• iii. Teeth with compromised bone support. iv. Patient with xerostomia or excessive salivation. v. Patient with abnormal tongue behavior and/or size.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Bites and Stings

Interventions

polyetheretherketone

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries

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 26, 2017
• First Posted: February 1, 2017
• Study Start: March 1, 2017
• Primary Completion: August 1, 2017
• Study Completion: October 1, 2017
• Last Updated: February 1, 2017

Record last verified: 2017-01