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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Mohamed A Gazzar, MSc contact

00201001537371

gazar_fantasy@yahoo.com

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.

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 groups in NCT03043456
Study groupRoleWhat they receive
Thermoplastic Resin groupActive comparatorThermoplastic complete denture placement is done (Thermoplastic Comfort Systems, inc.)
Receives: Device: Thermoplastic complete denture
conventional acrylic resin groupPlacebo comparatorConventional 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.

  1. Changes in Patient satisfaction

    Questionnaire

    Measured: 0 months , 3 months , 6 months

Secondary outcomes (1)
  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.

  1. First posted6 Feb 2017 (estimated)
  2. Study start1 Mar 2017 (estimated)
  3. Primary completion1 Aug 2017 (estimated)
  4. Study completion1 Sep 2017 (estimated)

Resources

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)
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 24298532
  • 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.

    PubMed 23718997
  • 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.

    PubMed 20339724
  • 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.

    PubMed 18050582
  • 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.

  • 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 16161124
  • 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.

    PubMed 19135715
  • NIRONEN P. Some possible uses for acrylic resins in dentistry. Odontol Tidskr. 1950;58(2):118-25. No abstract available.

    PubMed 14785900
  • 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.

    PubMed 287797
  • 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.

    PubMed 6985962

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.

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