Patient Satisfaction and Microbial Changes in Complete Dentures.

NCT03043456 | Unknown

• 1 other identifier: 28806032102395
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Satisfaction; Microbial Colonization

Outcome Measures

Primary Outcomes (1)

• Changes in Patient satisfaction

  Questionnaire

  0 months , 3 months , 6 months

Secondary Outcomes (1)

• changes in Microbial count

  0 months , 3 months , 6 months

Study Arms (2)

Thermoplastic Resin group

ACTIVE COMPARATOR

Thermoplastic complete denture placement is done (Thermoplastic Comfort Systems, inc.)

Device: Thermoplastic complete denture

conventional acrylic resin group

PLACEBO COMPARATOR

Conventional acrylic resin complete denture placement is done. (Acrostone, inc.)

Device: Conventional acrylic resin complete denture

Interventions

Thermoplastic complete denture DEVICE

A device used to substitute the teeth for edentulous patients made of thermoplastic resin

Thermoplastic Resin group

Conventional acrylic resin complete denture DEVICE

A device used to substitute the teeth for edentulous patients made of acrylic resin

conventional acrylic resin group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Related Publications (10)

• 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.

  PMID: 24298532 BACKGROUND

• 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.

  PMID: 23718997 BACKGROUND

• 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.

  PMID: 20339724 BACKGROUND

• 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.

  PMID: 18050582 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 16161124 BACKGROUND

• 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.

  PMID: 19135715 BACKGROUND

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

  PMID: 14785900 BACKGROUND

• 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.

  PMID: 287797 BACKGROUND

• 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.

  PMID: 6985962 BACKGROUND

MeSH Terms

Conditions

Personal Satisfaction; Communicable Diseases

Condition Hierarchy (Ancestors)

Behavior; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Amal A Rekaby, Ph.D.

  Cairo University

  STUDY CHAIR

• Azza A Farahat, Ph.D.

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Mohamed A Gazzar, MSc

CONTACT

00201001537371; gazar_fantasy@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: prospective , parallel, randomized clinical trial

Study Record Dates

• First Submitted: January 31, 2017
• First Posted: February 6, 2017
• Study Start: March 1, 2017
• Primary Completion: August 1, 2017
• Study Completion: September 1, 2017
• Last Updated: February 8, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share