Evaluation of Microbial Growth on Bre-Flex Versus PEEK Denture Base in Bilateral Maxillary Bounded Partial Denture

NCT03491306 | Unknown

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

Brief Summary

This study evaluate Microbial 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

Microbial Colonization

Keywords

PEEK; Breflex

Outcome Measures

Primary Outcomes (1)

• Microbial Growth

  cfu/ml

  3 weeks

Study Arms (2)

Group 1

ACTIVE COMPARATOR

patients will receive partial denture constructed from breflex material

Other: Breflex

Group 2

EXPERIMENTAL

patients will receive partial denture constructed from PEEK material

Other: PEEK

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 2

Breflex 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 1

Eligibility Criteria

• Age: 35 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 (30-55) 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

Related Publications (4)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Communicable Diseases

Interventions

polyetheretherketone

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nadia Abbas, PHD

  Cairo Universty

  STUDY DIRECTOR

Central Study Contacts

Moataz Ibrahim

CONTACT

1286263775; moataz.hashim@dentistry.cu.edu.eg

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: April 1, 2018
• First Posted: April 9, 2018
• Study Start: June 1, 2018
• Primary Completion: June 15, 2018
• Study Completion: July 15, 2018
• Last Updated: April 9, 2018

Record last verified: 2018-04