Candida Albicans InfectionNCT03462862
Evaluation of Candida Albicans Growth on BreFlex Versus PEEK Denture Base in Maxillary Bounded Partial Denture
A study testing PEEK and Bre-Flex in people with Candida Albicans Infection, run by Cairo University.
Trial 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 Read more about this study
- Who is it for?
- Ages 35 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Candida Albicans Infection
- What is being tested?
- PEEK and Bre-Flex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 28 Jun 2018to 1 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Candida Albicans Growth on Bre.Flex Versus PEEK ( Polyether Ether Ketone ) Denture Base in Bilateral Maxillary Bounded Partial Denture (Randomized Clinical Trial)
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
Read the 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.
- Conditions
- Candida Albicans Infection
- Being tested
- PEEK, Bre-Flex
- Keywords
- PEEK, Breflex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEKOther
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.
Bre-FlexOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | patients will receive partial denture constructed from PEEK material Receives: Other: PEEK |
| Group 2 | Active comparator | patients will receive partial denture constructed from breflex material Receives: Other: Bre-Flex |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start28 Jun 2018 (estimated)
- Primary completion22 Jul 2018 (estimated)
- Study completion1 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Candida Albicans InfectionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Sammy Mansour, Cairo University
- Investigators
- Nadia Abbas, MD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03462862
- Sponsor's protocol ID
- Peek vs Breflex
- Status last verified
- Mar 2018
- First submitted
- 22 Feb 2018
- Last updated
- 13 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 21194588Guiotti 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.
PubMed 26602149Parvizi 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.
PubMed 15210003Zoidis 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.
PubMed 26216668Pires 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.
PubMed 12453267
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Candida Albicans Growth on Bre.Flex Versus PEEK ( Polyether Ether Ketone ) Denture Base in Bilateral Maxillary Bounded Partial Denture (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT03462862
- Acronym / sponsor ID
- Peek vs Breflex
- Conditions
- Candida Albicans Infection
- Keywords
- PEEK, Breflex
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 28 Jun 2018 (estimated)
- Primary completion
- 22 Jul 2018 (estimated)
- Study completion
- 1 Aug 2018 (estimated)
- First posted
- 13 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 2 parallel groups one group will receive RPD with PEEK denture base and the other will get Bre Flex denture base material
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: PEEKpatients will receive partial denture constructed from PEEK material |
| Group 2 | Active comparator | Other: Bre-Flexpatients will receive partial denture constructed from breflex material |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEEKPEEK 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. | Other | Group 1 |
| Bre-FlexIn 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. | Other | Group 2 |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
- Background: PubMed 21194588de 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.
- Background: PubMed 26602149Guiotti 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.
- Background: PubMed 15210003Parvizi 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.
- Background: PubMed 26216668Zoidis 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.
- Background: PubMed 12453267Pires 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadia Abbas, MD study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing PEEK and Bre-Flex in people with Candida Albicans Infection, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Sammy (+201091090099, a7medsammy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Candida Albicans growth (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03462862, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2018.