DenturesNCT01188226
Wear Characteristics of Denture Teeth
A study testing Denture teeth in people with Dentures, run by University of California, Los Angeles at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Dentures
- What is being tested?
- Denture teeth
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Jun 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA School of Dentistry
Los Angeles, California, 90095
About this study
Official title: Evaluation of Wear Characteristics of Nano-Hybrid Denture Teeth
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
- Being tested
- Denture teeth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Denture teethDevice
Also called Ivoclar Vivadent Inc. SR Phonares denture teeth
Denture teeth made of nano hybrid composite material
| Study group | Role | What they receive |
|---|---|---|
| Nano Hybrid Composite Denture teeth | Experimental | Denture teeth are made of nano hybrid composite material Receives: Device: Denture teeth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Location of Posterior Denture Tooth Wear
Clinical evaluation of posterior wear location (right, left, equal).
Measured: 6 months after denture completion
Location of Posterior Denture Tooth Wear
Clinical evaluation of posterior wear location (right, left, equal)
Measured: 12 months after denture completion
Location of Posterior Denture Tooth Wear
Clinical evaluation of posterior wear location (right, left, equal)
Measured: 18 months after denture completion
Location of Posterior Denture Tooth Wear
Clinical evaluation of posterior wear location (right, left, equal)
Measured: 24 months after denture completion
Secondary outcomes (12)
Denture Teeth Esthetics
Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels: high, little, none)
Measured: 6 months after denture completion
Amount of Denture Teeth Plaque
Clinical evaluation of plaque for anterior teeth and left posterior teeth and right posterior teeth on four-point scale (0= none; 1 = soft debris covering ≤1/3 of tooth surface; 2 = soft debris covering > 1/3 and ≤ ½ of tooth surface; 3 = soft debris covering more than ½ of tooth surface)
Measured: 6 months after denture completion
Denture Teeth Calculus
Clinical evaluation of calculus for anterior teeth and posterior teeth on left and right sides on four-point scale (0= none; 1 = present on ≤ 1/3 of gingival margins; 2 = present on > 1/3 of gingival margins and parts of fissures and/or individual spots around cervical portion of tooth; 3 = covering more than ½ of gingival margins and the complete fissures and/or continuous heavy band of calculus around cervical portion of the tooth)
Measured: 6 months after denture completion
Denture Teeth Esthetics
Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels, high, little none)
Measured: 12 months after denture completion
Denture Teeth Esthetics
Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels: high, little, none)
Measured: 18 months after denture completion
Denture Teeth Esthetics
Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels: high, little, none)
Measured: 24 months after denture completion
Amount of Denture Teeth Plaque
Clinical evaluation of plaque for anterior teeth and left posterior teeth and right posterior teeth on four-point scale (0= none; 1 = soft debris covering ≤1/3 of tooth surface; 2 = soft debris covering > 1/3 and ≤ ½ of tooth surface; 3 = soft debris covering more than ½ of tooth surface)
Measured: 12 months after denture completion
Amount of Denture Teeth Plaque
Clinical evaluation of plaque for anterior teeth and left posterior teeth and right posterior teeth on four-point scale (0= none; 1 = soft debris covering ≤1/3 of tooth surface; 2 = soft debris covering > 1/3 and ≤ ½ of tooth surface; 3 = soft debris covering more than ½ of tooth surface)
Measured: 18 months after denture completion
Amount of Denture Teeth Plaque
Clinical evaluation of plaque for anterior teeth and left posterior teeth and right posterior teeth on four-point scale (0= none; 1 = soft debris covering ≤1/3 of tooth surface; 2 = soft debris covering > 1/3 and ≤ ½ of tooth surface; 3 = soft debris covering more than ½ of tooth surface)
Measured: 24 months after denture completion
Denture Teeth Calculus
Clinical evaluation of calculus for anterior teeth and posterior teeth on left and right sides on four-point scale (0= none; 1 = present on ≤ 1/3 of gingival margins; 2 = present on > 1/3 of gingival margins and parts of fissures and/or individual spots around cervical portion of tooth; 3 = covering more than ½ of gingival margins and the complete fissures and/or continuous heavy band of calculus around cervical portion of the tooth)
Measured: 12 months after denture completion
Denture Teeth Calculus
Clinical evaluation of calculus for anterior teeth and posterior teeth on left and right sides on four-point scale (0= none; 1 = present on ≤ 1/3 of gingival margins; 2 = present on > 1/3 of gingival margins and parts of fissures and/or individual spots around cervical portion of tooth; 3 = covering more than ½ of gingival margins and the complete fissures and/or continuous heavy band of calculus around cervical portion of the tooth)
Measured: 18 months after denture completion
Denture Teeth Calculus
Clinical evaluation of calculus for anterior teeth and posterior teeth on left and right sides on four-point scale (0= none; 1 = present on ≤ 1/3 of gingival margins; 2 = present on > 1/3 of gingival margins and parts of fissures and/or individual spots around cervical portion of tooth; 3 = covering more than ½ of gingival margins and the complete fissures and/or continuous heavy band of calculus around cervical portion of the tooth)
Measured: 24 months after denture completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2011
- Study completionJun 2015
Why it stopped: Enrollment difficulties and drop outs
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DenturesStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Ivoclar Vivadent AG
- Responsible party
- Principal investigator, Neal Garrett, University of California, Los Angeles
- Investigators
- Neal Garret, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01188226
- Sponsor's protocol ID
- 20101960
- Status last verified
- May 2016
- First submitted
- 24 Aug 2010
- Last updated
- 10 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Wear Characteristics of Nano-Hybrid Denture Teeth
- ClinicalTrials.gov ID
- NCT01188226
- Acronym / sponsor ID
- 20101960
- Conditions
- Dentures
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment difficulties and drop outs
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Ivoclar Vivadent AG
- Study start
- Aug 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 25 Aug 2010 (estimated)
- Results
- Posted 10 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nano Hybrid Composite Denture teeth | Experimental | Device: Denture teethDenture teeth are made of nano hybrid composite material |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Denture teethAlso: Ivoclar Vivadent Inc. SR Phonares denture teethDenture teeth made of nano hybrid composite material | Device | Nano Hybrid Composite Denture teeth |
Primary outcome
Location of Posterior Denture Tooth Wear
Time frame: 6 months after denture completion
Clinical evaluation of posterior wear location (right, left, equal).
Location of Posterior Denture Tooth Wear
Time frame: 12 months after denture completion
Clinical evaluation of posterior wear location (right, left, equal)
Location of Posterior Denture Tooth Wear
Time frame: 18 months after denture completion
Clinical evaluation of posterior wear location (right, left, equal)
Location of Posterior Denture Tooth Wear
Time frame: 24 months after denture completion
Clinical evaluation of posterior wear location (right, left, equal)
12 secondary outcomes
Denture Teeth Esthetics
Time frame: 6 months after denture completion
Amount of Denture Teeth Plaque
Time frame: 6 months after denture completion
Denture Teeth Calculus
Time frame: 6 months after denture completion
Denture Teeth Esthetics
Time frame: 12 months after denture completion
Denture Teeth Esthetics
Time frame: 18 months after denture completion
Denture Teeth Esthetics
Time frame: 24 months after denture completion
Amount of Denture Teeth Plaque
Time frame: 12 months after denture completion
Amount of Denture Teeth Plaque
Time frame: 18 months after denture completion
Amount of Denture Teeth Plaque
Time frame: 24 months after denture completion
Denture Teeth Calculus
Time frame: 12 months after denture completion
Denture Teeth Calculus
Time frame: 18 months after denture completion
Denture Teeth Calculus
Time frame: 24 months after denture completion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Dentures
Active, not recruiting
Clinical Evaluation of a New Printable Denture Base Material
Edentulous Mouth
Recruiting
Comparison of Conventional and Face Scan in Recording the Vertical Dimension of Completely Edentulous Patients
Edentulous Complete Denture Wearers
Not yet recruitingObservational study
Digital and Conventional Clasp-retained Partial Dentures (DIGICLASP)
Partial Edentulism
Active, not recruiting
Single-implant Versus Two-implant Mandibular Overdentures
Edentulism
Not yet recruiting
Comparison Between Neutral Zone and Admixed Impression Techniques for Atrophic Mandibular Ridges
Atrophic Mandibular Ridge in Edentulous Patients
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neal Garret, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Denture teeth in people with Dentures, run by University of California, Los Angeles at 1 site in United States.
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 3 inclusion and 8 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: stopped early, as of the sponsor's last update on 10 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Yes. Results are posted in the registry (first posted 10 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Location of Posterior Denture Tooth Wear (time frame: 6 months after denture completion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2016.