Wear Characteristics of Denture Teeth

NCT01188226 | Terminated Results

• 1 other identifier: 20101960
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dentures

Outcome Measures

Primary Outcomes (4)

• Location of Posterior Denture Tooth Wear

  Clinical evaluation of posterior wear location (right, left, equal).

  6 months after denture completion

• Location of Posterior Denture Tooth Wear

  Clinical evaluation of posterior wear location (right, left, equal)

  12 months after denture completion

• Location of Posterior Denture Tooth Wear

  Clinical evaluation of posterior wear location (right, left, equal)

  18 months after denture completion

• Location of Posterior Denture Tooth Wear

  Clinical evaluation of posterior wear location (right, left, equal)

  24 months after denture completion

Secondary Outcomes (12)

• Denture Teeth Esthetics

  6 months after denture completion

• Amount of Denture Teeth Plaque

  6 months after denture completion

• Denture Teeth Calculus

  6 months after denture completion

• Denture Teeth Esthetics

  12 months after denture completion

• Denture Teeth Esthetics

  18 months after denture completion

Study Arms (1)

Nano Hybrid Composite Denture teeth

EXPERIMENTAL

Denture teeth are made of nano hybrid composite material

Device: Denture teeth

Interventions

Denture teeth DEVICE

Denture teeth made of nano hybrid composite material

Also known as: Ivoclar Vivadent Inc. SR Phonares denture teeth

Nano Hybrid Composite Denture teeth

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Ivoclar Vivadent AG: collaborator

Study Sites (1)

UCLA School of Dentistry

Los Angeles, California, 90095, United States

Location

Results Point of Contact

• Title: Neal Garrett, MD
• Organization: UCLA

ngarrett@ucla.edu

Study Officials

• Neal Garret, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 24, 2010
• First Posted: August 25, 2010
• Study Start: August 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: June 1, 2015
• Last Updated: June 10, 2016
• Results First Posted: June 10, 2016

Record last verified: 2016-05

Locations

US (1)