Evaluation of Candida Albicans Growth on BreFlex Versus PEEK Denture Base in Maxillary Bounded Partial Denture

NCT03462862 | Unknown

• 1 other identifier: Peek vs Breflex
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluate Candida Albicans growth on Bre-Flex versus PEEK denture base in Bilateral Maxillary bounded partial denture , half of patients will receive a framework with breflex denture base and the other half will receive a framework with PEEK denture base then evaluate the Candida growth

Conditions

Candida Albicans Infection

Keywords

PEEK; Breflex

Outcome Measures

Primary Outcomes (1)

• Candida Albicans growth

  after insertion of the denture we will measure the Candida count using Light Microscope and record the CFU/ML (colony-forming units per milliliter) unit

  one month

Study Arms (2)

Group 1

EXPERIMENTAL

patients will receive partial denture constructed from PEEK material

Other: PEEK

Group 2

ACTIVE COMPARATOR

patients will receive partial denture constructed from breflex material

Other: Bre-Flex

Interventions

PEEK OTHER

PEEK has been successfully used over the last years in the medical field, and orthopedics, specifically. which presents high bio compatibility, 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 1

Bre-Flex OTHER

In the recent time thermoplastic materials become quite popular in clinical practice such as nylon and acetal resins. since the 1950, poly-amide 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 removable denture 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 2

Eligibility Criteria

• Age: 35 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 (30-55) 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 tempo-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

Related Publications (5)

• de Freitas Fernandes FS, Pereira-Cenci T, da Silva WJ, Filho AP, Straioto FG, Del Bel Cury AA. Efficacy of denture cleansers on Candida spp. biofilm formed on polyamide and polymethyl methacrylate resins. J Prosthet Dent. 2011 Jan;105(1):51-8. doi: 10.1016/S0022-3913(10)60192-8.

  PMID: 21194588 BACKGROUND

• Guiotti AM, Goiato MC, Dos Santos DM, Vechiato-Filho AJ, Cunha BG, Paulini MB, Moreno A, de Almeida MT. Comparison of conventional and plant-extract disinfectant solutions on the hardness and color stability of a maxillofacial elastomer after artificial aging. J Prosthet Dent. 2016 Apr;115(4):501-8. doi: 10.1016/j.prosdent.2015.09.009. Epub 2015 Nov 19.

  PMID: 26602149 BACKGROUND

• Parvizi A, Lindquist T, Schneider R, Williamson D, Boyer D, Dawson DV. Comparison of the dimensional accuracy of injection-molded denture base materials to that of conventional pressure-pack acrylic resin. J Prosthodont. 2004 Jun;13(2):83-9. doi: 10.1111/j.1532-849X.2004.04014.x.

  PMID: 15210003 BACKGROUND

• Zoidis P, Papathanasiou I, Polyzois G. The Use of a Modified Poly-Ether-Ether-Ketone (PEEK) as an Alternative Framework Material for Removable Dental Prostheses. A Clinical Report. J Prosthodont. 2016 Oct;25(7):580-584. doi: 10.1111/jopr.12325. Epub 2015 Jul 27.

  PMID: 26216668 BACKGROUND

• Pires FR, Santos EB, Bonan PR, De Almeida OP, Lopes MA. Denture stomatitis and salivary Candida in Brazilian edentulous patients. J Oral Rehabil. 2002 Nov;29(11):1115-9. doi: 10.1046/j.1365-2842.2002.00947.x.

  PMID: 12453267 BACKGROUND

MeSH Terms

Interventions

polyetheretherketone

Study Officials

• Nadia Abbas, MD

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Ahmed Sammy

CONTACT

+201091090099; a7medsammy@gmail.com

Study Design

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

Model Details: 2 parallel groups one group will receive RPD with PEEK denture base and the other will get Bre Flex denture base material

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: March 13, 2018
• Study Start: June 28, 2018
• Primary Completion: July 22, 2018
• Study Completion: August 1, 2018
• Last Updated: March 13, 2018

Record last verified: 2018-03