SatisfactionNCT03043456
Patient Satisfaction and Microbial Changes in Complete Dentures.
A study testing Thermoplastic complete denture and Conventional acrylic resin complete denture in people with Satisfaction and Microbial Colonization, run by Cairo University.
Trial summary
In this research, the investigators are comparing the new thermoplastic material side by side with the conventional poly methyl methacrylate for fully edentulous patients measuring their satisfaction and microbiological count. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Satisfaction, Microbial Colonization
- What is being tested?
- Thermoplastic complete denture and Conventional acrylic resin complete denture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2017to 1 Sep 2017
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Completely edentulous
- No bone irregularities, no bone specules, mild to moderate undercut.
- Good oral hygiene
- Should be co-operative
- No serious systemic disease
- No TMJ Problems
Who cannot join
- Bone irregularities , soft tissue ulcerations , severe undercuts
- Serious systemic problem
- Patient with xerostomia
- Severely resorbed ridge
- Logistic or physical reasons that could affect follow-up,
- Psychiatric problems
- Medically compromised patients \& those with neuromascular disorders
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Patient Satisfaction and Microbiological Changes in Injectable Thermoplastic Resin and Conventional Acrylic Resin Complete Dentures
In this research, the investigators are comparing the new thermoplastic material side by side with the conventional poly methyl methacrylate for fully edentulous patients measuring their satisfaction and microbiological count.
Read the detailed description
The restoration of masticatory function and aesthetics is an important aim in dentistry mainly when patients present with extensive tooth loss. The loss of tooth in elderly patients not only impairs the stomatognathic system but also their psychological status and quality of life.so an important criteria's for the success of dentures are patient's expectations and the ability of the denture to replace the lost masticatory efficiency.
The acrylic resin was first used in 1936; it was in that time the best alternative for vulcanized rubber. Where it is characterized by superior characteristics and became the most popular material used since then. Nonetheless, it has some problems such as polymerization shrinkage, weak flexural, lower impact strength, and low fatigue resistance. These often lead to denture failure during chewing or when fall out of the patient's hand. In order to enhance some properties of PMMA, various efforts have been taken including addition of metal wires or plates, fibers, metal inserts, and modification of chemical structure. In recent years, nylon polymer has attracted attention as a denture base material.
Thermoplastic nylon like materials or polyamides were introduced and first used in dentistry in 1950. The polyamide are uniquely characterized by high esthetics especially in removable partial dentures, where retentive components are recommended anteriorly by this material which provide high elasticity we can make the retentive components using the same material and eliminate the metallic clasps.
Polyamides are characterized by low weight and flexibility make it more patient satisfactory and fortunately it has no monomer remnants that may affect patient health and causes allergy. Thermoplastic polyamides have almost no porosity which eliminates water sorption. The technique used for its fabrication is injection molding technique which is more dimension accurate than packing mold technique.
Valplast was initially used just over 50 years ago and has been used in modern dentistry since the mid-fifties. A variation of nylon, which is far more flexible and stronger than poly methyl methacrylate resin, is used in many alternative partial dentures. Valplast flexible dentures are used for full sets of dentures especially in cases of acrylic allergy which represent 20% of the population.
Comparative Evaluation of Impact and Flexural Strength is done to four types of Four Commercially Available Flexible Denture Base Materials. Valplast had the maximum impact strength, so these materials should be used in less undercut areas for long-term interim removable partial dentures.
A study done by investigators who evaluated the surface roughness of four thermoplastic (polyamide: Valplast, Lucitone FRS, polyethylene terephthalate: EstheShot, and polyester: EstheShot Bright) and two conventional acrylic (Heat-polymerizing: Urban, and Pour type auto-polymerizing: Pro-Cast DSP) denture bases by using scratch test. The results showed that the surface of thermoplastic denture base resins was easily damaged compared with polymethyl methacrylate which can cause discomfort to patients and also discoloration.
Complete Dentures Made with High Impact and Flexible Resins were evaluated. There was statistically significant difference for masticatory performance in wet and dry weight values of hard food, but there was no statistically significant difference for masticatory performance in wet and dry weight values of soft food between the conventional and flexible dentures. Though masticatory efficiency and performance were found to be better for patient's dentures made with Polymethyl methacrylate (PMMA), a statistically significant number of patients reported that the flexible dentures were more satisfying than the conventional dentures.
Another study was done to evaluate the patients inflamatory response. patients received acrylic complete denture were associated with significant high levels of proinflammatory salivary cytokines (TNF-α and IL-6) in comparison to their corresponding levels in the thermoplastic polyamide complete denture patients. The high levels of pro-inflammatory salivary cytokines (TNF-α and IL-6) that were found in saliva of control group patients may be linked to their protective effect against tissue inflammation caused by release of residual monomer.
Adherence of Candida albicans to Flexible Denture Base Material was studied and concluded C. albicans has lesser opportunities to adhere on flexible denture than on acrylic resin denture base materials.
- Conditions
- Satisfaction, Microbial Colonization
- Being tested
- Thermoplastic complete denture, Conventional acrylic resin complete denture
- Medical subject headings
- Personal Satisfaction, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermoplastic complete dentureDevice
A device used to substitute the teeth for edentulous patients made of thermoplastic resin
Conventional acrylic resin complete dentureDevice
A device used to substitute the teeth for edentulous patients made of acrylic resin
| Study group | Role | What they receive |
|---|---|---|
| Thermoplastic Resin group | Active comparator | Thermoplastic complete denture placement is done (Thermoplastic Comfort Systems, inc.) Receives: Device: Thermoplastic complete denture |
| conventional acrylic resin group | Placebo comparator | Conventional acrylic resin complete denture placement is done. (Acrostone, inc.) Receives: Device: Conventional acrylic resin complete denture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Patient satisfaction
Questionnaire
Measured: 0 months , 3 months , 6 months
Secondary outcomes (1)
changes in Microbial count
CFU
Measured: 0 months , 3 months , 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2017 (estimated)
- Study start1 Mar 2017 (estimated)
- Primary completion1 Aug 2017 (estimated)
- Study completion1 Sep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for SatisfactionStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective , parallel, randomized clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Abdel Hamid, Cairo University
- Investigators
- Amal A Rekaby, Ph.D., Study chair, Cairo UniversityAzza A Farahat, Ph.D., Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03043456
- Sponsor's protocol ID
- 28806032102395
- Status last verified
- Feb 2017
- First submitted
- 31 Jan 2017
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available through contact by email of the principle investigator. (gazar\_fantasy@yahoo.com)
Publications
Singh K, Aeran H, Kumar N, Gupta N. Flexible thermoplastic denture base materials for aesthetical removable partial denture framework. J Clin Diagn Res. 2013 Oct;7(10):2372-3. doi: 10.7860/JCDR/2013/5020.3527. Epub 2013 Oct 5.
PubMed 24298532Osada H, Shimpo H, Hayakawa T, Ohkubo C. Influence of thickness and undercut of thermoplastic resin clasps on retentive force. Dent Mater J. 2013;32(3):381-9. doi: 10.4012/dmj.2012-284.
PubMed 23718997Goiato MC, Santos DM, Haddad MF, Pesqueira AA. Effect of accelerated aging on the microhardness and color stability of flexible resins for dentures. Braz Oral Res. 2010 Jan-Mar;24(1):114-9. doi: 10.1590/s1806-83242010000100019.
PubMed 20339724Samet N, Tau S, Findler M, Susarla SM, Findler M. Flexible, removable partial denture for a patient with systemic sclerosis (scleroderma) and microstomia: a clinical report and a three-year follow-up. Gen Dent. 2007 Nov-Dec;55(6):548-51.
PubMed 18050582León BL, Del Bel Cury AA, Rodrigues Garcia RC. Loss of residual monomer from resilient lining materials processed by different methods. Rev Odontol Ciêc. 2008;23:215-9.
Bayraktar G, Guvener B, Bural C, Uresin Y. Influence of polymerization method, curing process, and length of time of storage in water on the residual methyl methacrylate content in dental acrylic resins. J Biomed Mater Res B Appl Biomater. 2006 Feb;76(2):340-5. doi: 10.1002/jbm.b.30377.
PubMed 16161124Urban VM, Machado AL, Vergani CE, Giampaolo ET, Pavarina AC, de Almeida FG, Cass QB. Effect of water-bath post-polymerization on the mechanical properties, degree of conversion, and leaching of residual compounds of hard chairside reline resins. Dent Mater. 2009 May;25(5):662-71. doi: 10.1016/j.dental.2008.10.017. Epub 2009 Jan 10.
PubMed 19135715NIRONEN P. Some possible uses for acrylic resins in dentistry. Odontol Tidskr. 1950;58(2):118-25. No abstract available.
PubMed 14785900Giunta JL, Grauer I, Zablotsky N. Allergic contact stomatitis caused by acrylic resin. J Prosthet Dent. 1979 Aug;42(2):188-90. doi: 10.1016/0022-3913(79)90173-2. No abstract available.
PubMed 287797Weaver RE, Goebel WM. Reactions to acrylic resin dental prostheses. J Prosthet Dent. 1980 Feb;43(2):138-42. doi: 10.1016/0022-3913(80)90176-6.
PubMed 6985962
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patient Satisfaction and Microbiological Changes in Injectable Thermoplastic Resin and Conventional Acrylic Resin Complete Dentures
- ClinicalTrials.gov ID
- NCT03043456
- Acronym / sponsor ID
- 28806032102395
- Conditions
- Satisfaction, Microbial Colonization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (estimated)
- Primary completion
- 1 Aug 2017 (estimated)
- Study completion
- 1 Sep 2017 (estimated)
- First posted
- 6 Feb 2017 (estimated)
- 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.
In this research, the investigators are comparing the new thermoplastic material side by side with the conventional poly methyl methacrylate for fully edentulous patients measuring their satisfaction and microbiological count.
Detailed description
The restoration of masticatory function and aesthetics is an important aim in dentistry mainly when patients present with extensive tooth loss. The loss of tooth in elderly patients not only impairs the stomatognathic system but also their psychological status and quality of life.so an important criteria's for the success of dentures are patient's expectations and the ability of the denture to replace the lost masticatory efficiency.
The acrylic resin was first used in 1936; it was in that time the best alternative for vulcanized rubber. Where it is characterized by superior characteristics and became the most popular material used since then. Nonetheless, it has some problems such as polymerization shrinkage, weak flexural, lower impact strength, and low fatigue resistance. These often lead to denture failure during chewing or when fall out of the patient's hand. In order to enhance some properties of PMMA, various efforts have been taken including addition of metal wires or plates, fibers, metal inserts, and modification of chemical structure. In recent years, nylon polymer has attracted attention as a denture base material.
Thermoplastic nylon like materials or polyamides were introduced and first used in dentistry in 1950. The polyamide are uniquely characterized by high esthetics especially in removable partial dentures, where retentive components are recommended anteriorly by this material which provide high elasticity we can make the retentive components using the same material and eliminate the metallic clasps.
Polyamides are characterized by low weight and flexibility make it more patient satisfactory and fortunately it has no monomer remnants that may affect patient health and causes allergy. Thermoplastic polyamides have almost no porosity which eliminates water sorption. The technique used for its fabrication is injection molding technique which is more dimension accurate than packing mold technique.
Valplast was initially used just over 50 years ago and has been used in modern dentistry since the mid-fifties. A variation of nylon, which is far more flexible and stronger than poly methyl methacrylate resin, is used in many alternative partial dentures. Valplast flexible dentures are used for full sets of dentures especially in cases of acrylic allergy which represent 20% of the population.
Comparative Evaluation of Impact and Flexural Strength is done to four types of Four Commercially Available Flexible Denture Base Materials. Valplast had the maximum impact strength, so these materials should be used in less undercut areas for long-term interim removable partial dentures.
A study done by investigators who evaluated the surface roughness of four thermoplastic (polyamide: Valplast, Lucitone FRS, polyethylene terephthalate: EstheShot, and polyester: EstheShot Bright) and two conventional acrylic (Heat-polymerizing: Urban, and Pour type auto-polymerizing: Pro-Cast DSP) denture bases by using scratch test. The results showed that the surface of thermoplastic denture base resins was easily damaged compared with polymethyl methacrylate which can cause discomfort to patients and also discoloration.
Complete Dentures Made with High Impact and Flexible Resins were evaluated. There was statistically significant difference for masticatory performance in wet and dry weight values of hard food, but there was no statistically significant difference for masticatory performance in wet and dry weight values of soft food between the conventional and flexible dentures. Though masticatory efficiency and performance were found to be better for patient's dentures made with Polymethyl methacrylate (PMMA), a statistically significant number of patients reported that the flexible dentures were more satisfying than the conventional dentures.
Another study was done to evaluate the patients inflamatory response. patients received acrylic complete denture were associated with significant high levels of proinflammatory salivary cytokines (TNF-α and IL-6) in comparison to their corresponding levels in the thermoplastic polyamide complete denture patients. The high levels of pro-inflammatory salivary cytokines (TNF-α and IL-6) that were found in saliva of control group patients may be linked to their protective effect against tissue inflammation caused by release of residual monomer.
Adherence of Candida albicans to Flexible Denture Base Material was studied and concluded C. albicans has lesser opportunities to adhere on flexible denture than on acrylic resin denture base materials.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- prospective , parallel, randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Thermoplastic Resin group | Active comparator | Device: Thermoplastic complete dentureThermoplastic complete denture placement is done (Thermoplastic Comfort Systems, inc.) |
| conventional acrylic resin group | Placebo comparator | Device: Conventional acrylic resin complete dentureConventional acrylic resin complete denture placement is done. (Acrostone, inc.) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Completely edentulous
- No bone irregularities, no bone specules, mild to moderate undercut.
- Good oral hygiene
- Should be co-operative
- No serious systemic disease
Key exclusion criteria (7 listed)
- Bone irregularities , soft tissue ulcerations , severe undercuts
- Serious systemic problem
- Patient with xerostomia
- Severely resorbed ridge
- Logistic or physical reasons that could affect follow-up,
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 |
|---|---|---|
| Thermoplastic complete dentureA device used to substitute the teeth for edentulous patients made of thermoplastic resin | Device | Thermoplastic Resin group |
| Conventional acrylic resin complete dentureA device used to substitute the teeth for edentulous patients made of acrylic resin | Device | conventional acrylic resin group |
Primary outcome
Changes in Patient satisfaction
Time frame: 0 months , 3 months , 6 months
Questionnaire
1 secondary outcome
changes in Microbial count
Time frame: 0 months , 3 months , 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
- Background: PubMed 24298532Singh K, Aeran H, Kumar N, Gupta N. Flexible thermoplastic denture base materials for aesthetical removable partial denture framework. J Clin Diagn Res. 2013 Oct;7(10):2372-3. doi: 10.7860/JCDR/2013/5020.3527. Epub 2013 Oct 5.
- Background: PubMed 23718997Osada H, Shimpo H, Hayakawa T, Ohkubo C. Influence of thickness and undercut of thermoplastic resin clasps on retentive force. Dent Mater J. 2013;32(3):381-9. doi: 10.4012/dmj.2012-284.
- Background: PubMed 20339724Goiato MC, Santos DM, Haddad MF, Pesqueira AA. Effect of accelerated aging on the microhardness and color stability of flexible resins for dentures. Braz Oral Res. 2010 Jan-Mar;24(1):114-9. doi: 10.1590/s1806-83242010000100019.
- Background: PubMed 18050582Samet N, Tau S, Findler M, Susarla SM, Findler M. Flexible, removable partial denture for a patient with systemic sclerosis (scleroderma) and microstomia: a clinical report and a three-year follow-up. Gen Dent. 2007 Nov-Dec;55(6):548-51.
- BackgroundLeón BL, Del Bel Cury AA, Rodrigues Garcia RC. Loss of residual monomer from resilient lining materials processed by different methods. Rev Odontol Ciêc. 2008;23:215-9.
- Background: PubMed 16161124Bayraktar G, Guvener B, Bural C, Uresin Y. Influence of polymerization method, curing process, and length of time of storage in water on the residual methyl methacrylate content in dental acrylic resins. J Biomed Mater Res B Appl Biomater. 2006 Feb;76(2):340-5. doi: 10.1002/jbm.b.30377.
- Background: PubMed 19135715Urban VM, Machado AL, Vergani CE, Giampaolo ET, Pavarina AC, de Almeida FG, Cass QB. Effect of water-bath post-polymerization on the mechanical properties, degree of conversion, and leaching of residual compounds of hard chairside reline resins. Dent Mater. 2009 May;25(5):662-71. doi: 10.1016/j.dental.2008.10.017. Epub 2009 Jan 10.
- Background: PubMed 14785900NIRONEN P. Some possible uses for acrylic resins in dentistry. Odontol Tidskr. 1950;58(2):118-25. No abstract available.
- Background: PubMed 287797Giunta JL, Grauer I, Zablotsky N. Allergic contact stomatitis caused by acrylic resin. J Prosthet Dent. 1979 Aug;42(2):188-90. doi: 10.1016/0022-3913(79)90173-2. No abstract available.
- Background: PubMed 6985962Weaver RE, Goebel WM. Reactions to acrylic resin dental prostheses. J Prosthet Dent. 1980 Feb;43(2):138-42. doi: 10.1016/0022-3913(80)90176-6.
- Individual participant dataSharing planned: No. Data will be available through contact by email of the principle investigator. (gazar_fantasy@yahoo.com)
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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.
Amal A Rekaby, Ph.D. study chair
Cairo University
Azza A Farahat, Ph.D. study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Thermoplastic complete denture and Conventional acrylic resin complete denture in people with Satisfaction and Microbial Colonization, 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 6 inclusion and 7 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 8 Feb 2017. 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. Some participants in this study may receive a placebo. 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 Mohamed A Gazzar, MSc (00201001537371, gazar_fantasy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Patient satisfaction (time frame: 0 months , 3 months , 6 months). 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 NCT03043456, which also lists 10 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 8 Feb 2017.