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Enrollment difficulties and drop outs
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| Name | Class |
|---|---|
| Ivoclar Vivadent AG | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nano Hybrid Composite Denture teeth | Experimental | Denture teeth are made of nano hybrid composite material |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Denture teeth | Device | Denture teeth made of nano hybrid composite material |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Denture Teeth Esthetics | Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels: high, little, none) | 6 months after denture completion |
| Amount of Denture Teeth Plaque |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neal Garret, PhD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA School of Dentistry | Los Angeles | California | 90095 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nano Hybrid Composite Denture Teeth | Denture teeth are made of nano hybrid composite material Denture teeth: Denture teeth made of nano hybrid composite material |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Subjects that signed consent
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| ID | Title | Description |
|---|---|---|
| BG000 | Nano Hybrid Composite Denture Teeth | Denture teeth are made of nano hybrid composite material |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Location of Posterior Denture Tooth Wear | Clinical evaluation of posterior wear location (right, left, equal). | For study participants who completed the 6-month follow-up. Upper and lower dentures of each participant assessed and reported separately as Arms for this outcome. | Posted | Number | participants | 6 months after denture completion |
|
24 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nano Hybrid Composite Denture Teeth | Denture teeth are made of nano hybrid composite material |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Denture tooth fracture | Gastrointestinal disorders | One tooth or multiple teeth fractured and repaired during study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Neal Garrett, MD | UCLA | ngarrett@ucla.edu |
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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)
| 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) | 6 months after denture completion |
| Denture Teeth Esthetics | Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels, high, little none) | 12 months after denture completion |
| Denture Teeth Esthetics | Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels: high, little, none) | 18 months after denture completion |
| Denture Teeth Esthetics | Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels: high, little, none) | 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) | 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) | 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) | 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) | 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) | 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) | 24 months after denture completion |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Location of Posterior Denture Tooth Wear | Clinical evaluation of posterior wear location (right, left, equal) | For study participants who completed the 12-month follow-up. Upper and lower dentures assessed and reported separately as Arms for this outcome. | Posted | Number | participants | 12 months after denture completion |
|
|
|
| Primary | Location of Posterior Denture Tooth Wear | Clinical evaluation of posterior wear location (right, left, equal) | For study participants who completed the 18-month follow-up. Upper and lower dentures of each participant assessed and reported separately as Arms for this outcome.One participant had the lower denture refabricated after 12 months and was not included in 18-month lower-denture assessment | Posted | Number | participants | 18 months after denture completion |
|
|
|
| Primary | Location of Posterior Denture Tooth Wear | Clinical evaluation of posterior wear location (right, left, equal) | For study participants who completed the 24-month follow-up. Upper and lower dentures of each participant assessed and reported separately as Arms for this outcome.One participant had the lower denture refabricated after 12 months and was not included in 24-month lower-denture assessment | Posted | Number | participants | 24 months after denture completion |
|
|
|
| Secondary | Denture Teeth Esthetics | Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels: high, little, none) | Posted | Number | participants | 6 months after denture completion |
|
|
|
| Secondary | 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) | For study participants who completed the 6-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome. | Posted | Number | participants | 6 months after denture completion |
|
|
|
| Secondary | 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) | For study participants who completed the 6-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome. | Posted | Number | participants | 6 months after denture completion |
|
|
|
| Secondary | Denture Teeth Esthetics | Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels, high, little none) | For study participants who completed the 12-month follow-up. | Posted | Number | participants | 12 months after denture completion |
|
|
|
| Secondary | Denture Teeth Esthetics | Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels: high, little, none) | For study participants who completed the 18-month follow-up. | Posted | Number | participants | 18 months after denture completion |
|
|
|
| Secondary | Denture Teeth Esthetics | Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels: high, little, none) | For study participants who completed the 24-month follow-up. | Posted | Number | participants | 24 months after denture completion |
|
|
|
| Secondary | 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) | For study participants who completed the 12-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome. | Posted | Number | participants | 12 months after denture completion |
|
|
|
| Secondary | 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) | For study participants who completed the 18-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome. | Posted | Number | participants | 18 months after denture completion |
|
|
|
| Secondary | 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) | For study participants who completed the 24-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome. | Posted | Number | participants | 24 months after denture completion |
|
|
|
| Secondary | 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) | For study participants who completed the 12-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome. | Posted | Number | participants | 12 months after denture completion |
|
|
|
| Secondary | 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) | For study participants who completed the 18-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome. | Posted | Number | participants | 18 months after denture completion |
|
|
|
| Secondary | 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) | For study participants who completed the 24-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome. | Posted | Number | participants | 24 months after denture completion |
|
|
|
| 0 |
| 10 |
| 6 |
| 10 |
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| Lower denture break | Gastrointestinal disorders | Lower denture broke at midline and was replaced during the study |
|
| Tooth debonding | Gastrointestinal disorders | Tooth debonding requiring recementation |
|
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| Left side wear |
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| Left side |
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| Left side |
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| 2=soft debris covering > 1/3 and ≤ ½ of surface |
|
| 3=soft debris covering more than ½ of surface |
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| Title | Measurements |
|---|---|
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| 2 |
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| 3 |
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| Title | Measurements |
|---|
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| 2 = soft debris covering > 1/3 and ≤ ½ of surface |
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| 3 = soft debris covering more than ½ of surface |
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| 2 = soft debris covering > 1/3 and ≤ ½ of surface |
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| 3 = soft debris covering more than ½ of surface |
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| 2 = soft debris covering > 1/3 and ≤ ½ of surface |
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| 3 = soft debris covering more than ½ of surface |
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| Title | Measurements |
|---|---|
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| 2 |
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| 3 |
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| Title | Measurements |
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| 2 |
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| 3 |
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| Title | Measurements |
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| 2 |
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| 3 |
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