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

Primary Purpose

Microbial Colonization

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PEEK
Breflex
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Microbial Colonization focused on measuring PEEK, Breflex

Eligibility Criteria

35 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Group 1

    Group 2

    Arm Description

    patients will receive partial denture constructed from breflex material

    patients will receive partial denture constructed from PEEK material

    Outcomes

    Primary Outcome Measures

    Microbial Growth
    cfu/ml

    Secondary Outcome Measures

    Full Information

    First Posted
    April 1, 2018
    Last Updated
    April 1, 2018
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03491306
    Brief Title
    Evaluation of Microbial Growth on Bre-Flex Versus PEEK Denture Base in Bilateral Maxillary Bounded Partial Denture
    Official Title
    Evaluation of Microbial Growth on Bre-Flex Versus PEEK Denture Base in Bilateral Maxillary Bounded Partial Denture
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2018 (Anticipated)
    Primary Completion Date
    June 15, 2018 (Anticipated)
    Study Completion Date
    July 15, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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
    Detailed Description
    Peek and Bre.flex are both new material that introduced to the market recently with great benefits like aesthetics and bio-compatibility but which material has less candida growth ? Bre.flex is a nylon-based thermoplastic material, composed of nylon polyamide 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. Despite of its highly esthetics features, Nylon still suffers from surface roughness that increase the colonization for candida but less than heat cured acrylic Recently, PEEK is introduced as a removable prosthesis material due to its high mechanical and biological properties but further clinical studies or systematic reviews focusing on the use of PEEK dentures are needed. The patient will be treated in visits designated as follows: Visit 1: Preoperative records, clinical, radiographic examination (panoramic and periapical x-rays for evaluation the crown-root ratio, the apical condition of the abutment and their alveolar bone support of abutment) and primary 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. Visit 2: Maxillary Face-bow will be recorded. The diagnostic casts will be mounted on semi adjustable articulator in centric occluding relation to evaluate the inter arch distance and occlusal plane. Visit 3: primary surveying is performed. Special trays will be constructed and Mouth preparation will be performed by preparing guiding planes and rests seats on the abutments. 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: framework for edentulous areas on both sides connected with palatal strap. Aker's clasp on all abutments with buccal retention. Visit 4: the metal framework is tried into the patient's mouth. Jaw relation is recorded. Visit 5: The framework will be tried in with acrylic teeth in patient's mouth. Visit 6: 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. Visit7, 8, 9: clinical measurement will be performed for one month in three visits.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Microbial Colonization
    Keywords
    PEEK, Breflex

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    2 parallel groups one group will receive RPD with PEEK denture base and the other will get Bre Flex denture base material
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    18 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    Active Comparator
    Arm Description
    patients will receive partial denture constructed from breflex material
    Arm Title
    Group 2
    Arm Type
    Experimental
    Arm Description
    patients will receive partial denture constructed from PEEK material
    Intervention Type
    Other
    Intervention Name(s)
    PEEK
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Breflex
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Microbial Growth
    Description
    cfu/ml
    Time Frame
    3 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Moataz Ibrahim
    Phone
    1286263775
    Ext
    +20
    Email
    moataz.hashim@dentistry.cu.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nadia Abbas, PHD
    Organizational Affiliation
    Cairo Universty
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    21194588
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    15210003
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    26602149
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    12453267
    Citation
    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.
    Results Reference
    result

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

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