Evaluation of Candida Albicans Growth on Bre.Flex Versus PEEK ( Polyether Ether Ketone ) Denture Base in Bilateral Maxillary Bounded Partial Denture (Randomized Clinical Trial)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Cairo University
- Enrollment
- 18
- Primary Endpoint
- Candida Albicans growth
Study Overview
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 35 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Group 1
patients will receive partial denture constructed from PEEK material
Intervention: PEEK (Other)
Group 2
patients will receive partial denture constructed from breflex material
Intervention: Bre-Flex (Other)
Outcomes
Primary Outcomes
Candida Albicans growth
Time Frame: one month
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Ahmed Sammy Mansour
Principal Investigator
Cairo University