Patient Satisfaction and Microbial Changes in Complete Dentures.
Primary Purpose
Satisfaction, Microbial Colonization
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Thermoplastic complete denture
Conventional acrylic resin complete denture
Sponsored by
About this trial
This is an interventional health services research trial for Satisfaction
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Thermoplastic Resin group
conventional acrylic resin group
Arm Description
Thermoplastic complete denture placement is done (Thermoplastic Comfort Systems, inc.)
Conventional acrylic resin complete denture placement is done. (Acrostone, inc.)
Outcomes
Primary Outcome Measures
Changes in Patient satisfaction
Questionnaire
Secondary Outcome Measures
changes in Microbial count
CFU
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03043456
Brief Title
Patient Satisfaction and Microbial Changes in Complete Dentures.
Official Title
Evaluation of Patient Satisfaction and Microbiological Changes in Injectable Thermoplastic Resin and Conventional Acrylic Resin Complete Dentures
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Anticipated)
Primary Completion Date
August 1, 2017 (Anticipated)
Study Completion Date
September 1, 2017 (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
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Satisfaction, Microbial Colonization
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective , parallel, randomized clinical trial
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
The study will be blinded regarding the statistician who is responsible for data analysis.
The participant patients will be blinded. The outcome assessor for patient satisfaction can be blinded during the questionnaire. On the other hand, Microbial count assessor will not be blinded during swab taking while the lab technician can be blinded. but The operator cannot be blinded.
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Thermoplastic Resin group
Arm Type
Active Comparator
Arm Description
Thermoplastic complete denture placement is done (Thermoplastic Comfort Systems, inc.)
Arm Title
conventional acrylic resin group
Arm Type
Placebo Comparator
Arm Description
Conventional acrylic resin complete denture placement is done. (Acrostone, inc.)
Intervention Type
Device
Intervention Name(s)
Thermoplastic complete denture
Intervention Description
A device used to substitute the teeth for edentulous patients made of thermoplastic resin
Intervention Type
Device
Intervention Name(s)
Conventional acrylic resin complete denture
Intervention Description
A device used to substitute the teeth for edentulous patients made of acrylic resin
Primary Outcome Measure Information:
Title
Changes in Patient satisfaction
Description
Questionnaire
Time Frame
0 months , 3 months , 6 months
Secondary Outcome Measure Information:
Title
changes in Microbial count
Description
CFU
Time Frame
0 months , 3 months , 6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed A Gazzar, MSc
Phone
00201001537371
Email
gazar_fantasy@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amal A Rekaby, Ph.D.
Organizational Affiliation
Cairo University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Azza A Farahat, Ph.D.
Organizational Affiliation
Cairo University
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will be available through contact by email of the principle investigator. (gazar_fantasy@yahoo.com)
Citations:
PubMed Identifier
24298532
Citation
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.
Results Reference
background
PubMed Identifier
23718997
Citation
Osada 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.
Results Reference
background
PubMed Identifier
20339724
Citation
Goiato 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.
Results Reference
background
PubMed Identifier
18050582
Citation
Samet 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.
Results Reference
background
Citation
León 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.
Results Reference
background
PubMed Identifier
16161124
Citation
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.
Results Reference
background
PubMed Identifier
19135715
Citation
Urban 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.
Results Reference
background
PubMed Identifier
14785900
Citation
NIRONEN P. Some possible uses for acrylic resins in dentistry. Odontol Tidskr. 1950;58(2):118-25. No abstract available.
Results Reference
background
PubMed Identifier
287797
Citation
Giunta 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.
Results Reference
background
PubMed Identifier
6985962
Citation
Weaver 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.
Results Reference
background
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Patient Satisfaction and Microbial Changes in Complete Dentures.
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