Wear Characteristics of Denture Teeth

Dentures Clinical Trial

Official title:

Evaluation of Wear Characteristics of Nano-Hybrid Denture Teeth

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01188226
• Other study ID #: 20101960
• Status: Enrolling by invitation
• Phase: N/A
• First received: August 24, 2010
• Last updated: August 24, 2010
• Start date: August 2010

Study information

• Verified date: August 2010
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The majority of teeth utilized in the fabrication of conventional complete dentures are made of acrylic resins. These acrylic teeth provide increased bond strength to the denture base and are much easier to adjust for correct denture occlusion compared to teeth made of harder materials, such as porcelain. However, the acrylic teeth will wear faster than the porcelain teeth, leading to alterations in how the teeth contact each other if the denture is not replaced periodically (typically every 5-8 years). With the increase in biting and chewing forces that can be achieved during function with dentures supported by dental implants, the rate of tooth wear may be increased, leading to more frequent need for replacement of the prosthesis. Acrylic teeth made of nano hybrid composite material (NHC) potentially offer greater wear resistance and aesthetic characteristics. The NHC teeth employ a wide range of fillers, including highly cross-linked organic macrofillers, high-density inorganic microfillers and silanized silica based nanofillers. The macrofillers are, to a large part, responsible for the adequate strength and color-stability of the teeth, whereas the microfillers improve the wear resistance. The nanofillers offer fundamentally different optical behaviour from those of larger fillers, improving light reflection without lowering the translucency. This offers additional opportunities in the development of composite teeth, which have to exhibit lifelike aesthetics and translucency. These teeth made of nano-particles and hybrid composites can be made with two different techniques, one where the materials are pressed together and another using an injection technique. The injection method has been found to have better aesthetic results, but resistance to wear in clinical use has not been established.

The purpose of this study is to evaluate the wear characteristics of new resin denture teeth (nano particles - hybrid composite) made by an injection technique. Twenty-four edentulous subjects will be enrolled who have completed implant placement for mandibular implant overdentures opposing a maxillary complete denture or implant overdenture, or patients that have previously received these dentures and are interested in having new dentures. Both maxillary and mandibular dentures will be fabricated using injection molded nano-hybrid composite denture teeth. The wear of denture teeth will be evaluated using stereophotographic recordings at baseline, 6, 12, 18 and 24 months after denture treatment.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 24
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Being treated at UCLA School of Dentistry clinics with implant-assisted mandibular overdentures and conventional maxillary complete dentures or implant overdentures

• Previously treated at UCLA School of Dentistry clinics with implant-assisted mandibular overdentures and conventional maxillary complete dentures or implant overdentures and desires new dentures

• Have healthy, normal soft and hard oral tissues

Exclusion Criteria:

• Oral and medical conditions which would interfere with follow-up evaluations over a two-year period after denture treatment completion

• Abnormal oral soft or hard tissues that prevents conventional denture fabrication

• Impaired dexterity the prevents proper oral hygiene

• Allergy to denture base materials

• Severe parafunction based on current condition of existing dentures

• Any limitation in mouth opening or closing

• Severe TMD symptoms

• Employees (and their immediate families) of the UCLA School of Dentistry

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dentures

Intervention

Device:
• Denture teeth
Denture teeth made of nano hybrid composite material

Locations

Country	Name	City	State
United States	UCLA School of Dentistry	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	Ivoclar Vivadent AG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	denture tooth wear		6 months after denture completion	No
Primary	denture tooth wear		12 months after denture completion	No
Primary	denture tooth wear		18 months after denture completion	No
Primary	denture tooth wear		24 months after denture completion	No
Secondary	denture teeth esthetics		6 months after denture completion	No
Secondary	denture teeth plaque		6 months after denture completion	No
Secondary	denture teeth calculus		6 months after denture completion	No
Secondary	denture teeth esthetics		12 months after denture completion	No
Secondary	denture teeth esthetics		18 months after denture completion	No
Secondary	denture teeth esthetics		24 months after denture completion	No
Secondary	denture teeth plaque		12 months after denture completion	No
Secondary	denture teeth plaque		18 months after denture completion	No
Secondary	denture teeth plaque		24 months after denture completion	No
Secondary	denture teeth calculus		12 months after denture completion	No
Secondary	denture teeth calculus		18 months after denture completion	No
Secondary	denture teeth calculus		24 months after denture completion	No