An interventional study of PEEK and Breflex in Microbial Colonization, sponsored by Cairo University. Status unknown. Open to participants aged 35 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-09.
Sponsored by Cairo University · Not applicable, Interventional, and Other
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
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.
4,447 studies on the registry are indexed under Communicable Diseases; 514 are open to participants now.
This study's planned enrollment of 18 is below the median of 121 across 2,712 interventional studies indexed under Communicable Diseases.
Browse Communicable Diseases studies →Cairo University is the lead sponsor of 4,909 studies on the registry; 1,445 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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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:
iii. Teeth with compromised bone support. iv. Patient with xerostomia or excessive salivation. v. Patient with abnormal tongue behavior and/or size.
patients will receive partial denture constructed from breflex material
Other: Breflex
patients will receive partial denture constructed from PEEK material
Other: PEEK
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.
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.
Microbial Growth
cfu/ml
Time frame: 3 weeks
No study locations are listed for this record.
Plan to share: Undecided
Start is estimated for Jun 2018; primary completion for Jun 2018, 0 months later.
Of 512 non-industry interventional studies with no phase under Communicable Diseases, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 0 months is below that.
Counting every sponsor, half of 557 studies reached it within 22 months; a quarter within 9 and three quarters within 37.
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