Skip to content

Wear Characteristics of Denture Teeth

Evaluation of Wear Characteristics of Nano-Hybrid Denture Teeth

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01188226
Enrollment
10
Registered
2010-08-25
Start date
2010-08-31
Completion date
2015-06-30
Last updated
2016-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dentures

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.

Interventions

DEVICEDenture teeth

Denture teeth made of nano hybrid composite material

Sponsors

Ivoclar Vivadent AG
CollaboratorINDUSTRY
University of California, Los Angeles
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Location of Posterior Denture Tooth Wear6 months after denture completionClinical evaluation of posterior wear location (right, left, equal).

Secondary

MeasureTime frameDescription
Denture Teeth Esthetics6 months after denture completionClinical evaluation of color deviation of anterior teeth to shade guide (3 levels: high, little, none)
Amount of Denture Teeth Plaque6 months after denture completionClinical 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)
Denture Teeth Calculus6 months after denture completionClinical 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)

Countries

United States

Participant flow

Participants by arm

ArmCount
Nano Hybrid Composite Denture Teeth
Denture teeth are made of nano hybrid composite material
10
Total10

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyWithdrawal by Subject4

Baseline characteristics

CharacteristicNano Hybrid Composite Denture Teeth
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
5 Participants
Age, Categorical
Between 18 and 65 years
5 Participants
Region of Enrollment
United States
10 participants
Sex: Female, Male
Female
5 Participants
Sex: Female, Male
Male
5 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
6 / 10
serious
Total, serious adverse events
0 / 10

Outcome results

Primary

Location of Posterior Denture Tooth Wear

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

Time frame: 6 months after denture completion

Population: 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.

ArmMeasureGroupValue (NUMBER)
Upper DentureLocation of Posterior Denture Tooth WearRight side wear0 participants
Upper DentureLocation of Posterior Denture Tooth WearEqual wear7 participants
Upper DentureLocation of Posterior Denture Tooth WearLeft side wear1 participants
Lower DentureLocation of Posterior Denture Tooth WearRight side wear0 participants
Lower DentureLocation of Posterior Denture Tooth WearEqual wear6 participants
Lower DentureLocation of Posterior Denture Tooth WearLeft side wear2 participants
Primary

Location of Posterior Denture Tooth Wear

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

Time frame: 18 months after denture completion

Population: 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

ArmMeasureGroupValue (NUMBER)
Upper DentureLocation of Posterior Denture Tooth WearRight side0 participants
Upper DentureLocation of Posterior Denture Tooth WearEqual3 participants
Upper DentureLocation of Posterior Denture Tooth WearLeft side1 participants
Lower DentureLocation of Posterior Denture Tooth WearRight side0 participants
Lower DentureLocation of Posterior Denture Tooth WearEqual2 participants
Lower DentureLocation of Posterior Denture Tooth WearLeft side1 participants
Primary

Location of Posterior Denture Tooth Wear

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

Time frame: 12 months after denture completion

Population: For study participants who completed the 12-month follow-up. Upper and lower dentures assessed and reported separately as Arms for this outcome.

ArmMeasureGroupValue (NUMBER)
Upper DentureLocation of Posterior Denture Tooth WearRight side wear0 participants
Upper DentureLocation of Posterior Denture Tooth WearEqual wear6 participants
Upper DentureLocation of Posterior Denture Tooth WearLeft side wear1 participants
Lower DentureLocation of Posterior Denture Tooth WearRight side wear1 participants
Lower DentureLocation of Posterior Denture Tooth WearEqual wear5 participants
Lower DentureLocation of Posterior Denture Tooth WearLeft side wear1 participants
Primary

Location of Posterior Denture Tooth Wear

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

Time frame: 24 months after denture completion

Population: 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

ArmMeasureGroupValue (NUMBER)
Upper DentureLocation of Posterior Denture Tooth WearRight side0 participants
Upper DentureLocation of Posterior Denture Tooth WearEqual5 participants
Upper DentureLocation of Posterior Denture Tooth WearLeft side1 participants
Lower DentureLocation of Posterior Denture Tooth WearRight side0 participants
Lower DentureLocation of Posterior Denture Tooth WearEqual5 participants
Lower DentureLocation of Posterior Denture Tooth WearLeft side0 participants
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)

Time frame: 24 months after denture completion

Population: 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.

ArmMeasureGroupValue (NUMBER)
Upper DentureAmount of Denture Teeth Plaque0 = None5 participants
Upper DentureAmount of Denture Teeth Plaque1 = soft debris covering ≤1/3 of tooth surface0 participants
Upper DentureAmount of Denture Teeth Plaque2 = soft debris covering > 1/3 and ≤ ½ of surface1 participants
Upper DentureAmount of Denture Teeth Plaque3 = soft debris covering more than ½ of surface0 participants
Lower DentureAmount of Denture Teeth Plaque3 = soft debris covering more than ½ of surface0 participants
Lower DentureAmount of Denture Teeth Plaque0 = None4 participants
Lower DentureAmount of Denture Teeth Plaque2 = soft debris covering > 1/3 and ≤ ½ of surface0 participants
Lower DentureAmount of Denture Teeth Plaque1 = soft debris covering ≤1/3 of tooth surface2 participants
Left-posterior Denture TeethAmount of Denture Teeth Plaque3 = soft debris covering more than ½ of surface0 participants
Left-posterior Denture TeethAmount of Denture Teeth Plaque1 = soft debris covering ≤1/3 of tooth surface2 participants
Left-posterior Denture TeethAmount of Denture Teeth Plaque2 = soft debris covering > 1/3 and ≤ ½ of surface0 participants
Left-posterior Denture TeethAmount of Denture Teeth Plaque0 = None4 participants
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)

Time frame: 12 months after denture completion

Population: 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.

ArmMeasureGroupValue (NUMBER)
Upper DentureAmount of Denture Teeth Plaque3 = soft debris covering more than ½ of surface0 participants
Upper DentureAmount of Denture Teeth Plaque2 = soft debris covering > 1/3 and ≤ ½ of surface0 participants
Upper DentureAmount of Denture Teeth Plaque0= none6 participants
Upper DentureAmount of Denture Teeth Plaque1 = soft debris covering ≤1/3 of tooth surface1 participants
Lower DentureAmount of Denture Teeth Plaque2 = soft debris covering > 1/3 and ≤ ½ of surface0 participants
Lower DentureAmount of Denture Teeth Plaque0= none6 participants
Lower DentureAmount of Denture Teeth Plaque1 = soft debris covering ≤1/3 of tooth surface1 participants
Lower DentureAmount of Denture Teeth Plaque3 = soft debris covering more than ½ of surface0 participants
Left-posterior Denture TeethAmount of Denture Teeth Plaque1 = soft debris covering ≤1/3 of tooth surface2 participants
Left-posterior Denture TeethAmount of Denture Teeth Plaque0= none5 participants
Left-posterior Denture TeethAmount of Denture Teeth Plaque3 = soft debris covering more than ½ of surface0 participants
Left-posterior Denture TeethAmount of Denture Teeth Plaque2 = soft debris covering > 1/3 and ≤ ½ of surface0 participants
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)

Time frame: 6 months after denture completion

Population: 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.

ArmMeasureGroupValue (NUMBER)
Upper DentureAmount of Denture Teeth Plaque0=None5 participants
Upper DentureAmount of Denture Teeth Plaque1=Soft debris covering ≤1/3 of surface2 participants
Upper DentureAmount of Denture Teeth Plaque2=soft debris covering > 1/3 and ≤ ½ of surface1 participants
Upper DentureAmount of Denture Teeth Plaque3=soft debris covering more than ½ of surface0 participants
Lower DentureAmount of Denture Teeth Plaque3=soft debris covering more than ½ of surface0 participants
Lower DentureAmount of Denture Teeth Plaque0=None5 participants
Lower DentureAmount of Denture Teeth Plaque2=soft debris covering > 1/3 and ≤ ½ of surface1 participants
Lower DentureAmount of Denture Teeth Plaque1=Soft debris covering ≤1/3 of surface2 participants
Left-posterior Denture TeethAmount of Denture Teeth Plaque3=soft debris covering more than ½ of surface0 participants
Left-posterior Denture TeethAmount of Denture Teeth Plaque1=Soft debris covering ≤1/3 of surface2 participants
Left-posterior Denture TeethAmount of Denture Teeth Plaque2=soft debris covering > 1/3 and ≤ ½ of surface1 participants
Left-posterior Denture TeethAmount of Denture Teeth Plaque0=None5 participants
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)

Time frame: 18 months after denture completion

Population: 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.

ArmMeasureGroupValue (NUMBER)
Upper DentureAmount of Denture Teeth Plaque0 = None3 participants
Upper DentureAmount of Denture Teeth Plaque1 = soft debris covering ≤1/3 of tooth surface1 participants
Upper DentureAmount of Denture Teeth Plaque2 = soft debris covering > 1/3 and ≤ ½ of surface0 participants
Upper DentureAmount of Denture Teeth Plaque3 = soft debris covering more than ½ of surface0 participants
Lower DentureAmount of Denture Teeth Plaque3 = soft debris covering more than ½ of surface0 participants
Lower DentureAmount of Denture Teeth Plaque0 = None4 participants
Lower DentureAmount of Denture Teeth Plaque2 = soft debris covering > 1/3 and ≤ ½ of surface0 participants
Lower DentureAmount of Denture Teeth Plaque1 = soft debris covering ≤1/3 of tooth surface0 participants
Left-posterior Denture TeethAmount of Denture Teeth Plaque3 = soft debris covering more than ½ of surface0 participants
Left-posterior Denture TeethAmount of Denture Teeth Plaque1 = soft debris covering ≤1/3 of tooth surface0 participants
Left-posterior Denture TeethAmount of Denture Teeth Plaque2 = soft debris covering > 1/3 and ≤ ½ of surface0 participants
Left-posterior Denture TeethAmount of Denture Teeth Plaque0 = None4 participants
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)

Time frame: 24 months after denture completion

Population: 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.

ArmMeasureGroupValue (NUMBER)
Upper DentureDenture Teeth Calculus06 participants
Upper DentureDenture Teeth Calculus10 participants
Upper DentureDenture Teeth Calculus20 participants
Upper DentureDenture Teeth Calculus30 participants
Lower DentureDenture Teeth Calculus30 participants
Lower DentureDenture Teeth Calculus04 participants
Lower DentureDenture Teeth Calculus20 participants
Lower DentureDenture Teeth Calculus12 participants
Left-posterior Denture TeethDenture Teeth Calculus30 participants
Left-posterior Denture TeethDenture Teeth Calculus12 participants
Left-posterior Denture TeethDenture Teeth Calculus20 participants
Left-posterior Denture TeethDenture Teeth Calculus04 participants
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)

Time frame: 6 months after denture completion

Population: 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.

ArmMeasureGroupValue (NUMBER)
Upper DentureDenture Teeth Calculus08 participants
Upper DentureDenture Teeth Calculus10 participants
Upper DentureDenture Teeth Calculus20 participants
Upper DentureDenture Teeth Calculus30 participants
Lower DentureDenture Teeth Calculus30 participants
Lower DentureDenture Teeth Calculus08 participants
Lower DentureDenture Teeth Calculus20 participants
Lower DentureDenture Teeth Calculus10 participants
Left-posterior Denture TeethDenture Teeth Calculus30 participants
Left-posterior Denture TeethDenture Teeth Calculus10 participants
Left-posterior Denture TeethDenture Teeth Calculus20 participants
Left-posterior Denture TeethDenture Teeth Calculus08 participants
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)

Time frame: 12 months after denture completion

Population: 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.

ArmMeasureGroupValue (NUMBER)
Upper DentureDenture Teeth Calculus06 participants
Upper DentureDenture Teeth Calculus11 participants
Upper DentureDenture Teeth Calculus20 participants
Upper DentureDenture Teeth Calculus30 participants
Lower DentureDenture Teeth Calculus30 participants
Lower DentureDenture Teeth Calculus06 participants
Lower DentureDenture Teeth Calculus20 participants
Lower DentureDenture Teeth Calculus11 participants
Left-posterior Denture TeethDenture Teeth Calculus30 participants
Left-posterior Denture TeethDenture Teeth Calculus11 participants
Left-posterior Denture TeethDenture Teeth Calculus20 participants
Left-posterior Denture TeethDenture Teeth Calculus06 participants
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)

Time frame: 18 months after denture completion

Population: 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.

ArmMeasureGroupValue (NUMBER)
Upper DentureDenture Teeth Calculus04 participants
Upper DentureDenture Teeth Calculus10 participants
Upper DentureDenture Teeth Calculus20 participants
Upper DentureDenture Teeth Calculus30 participants
Lower DentureDenture Teeth Calculus30 participants
Lower DentureDenture Teeth Calculus04 participants
Lower DentureDenture Teeth Calculus20 participants
Lower DentureDenture Teeth Calculus10 participants
Left-posterior Denture TeethDenture Teeth Calculus30 participants
Left-posterior Denture TeethDenture Teeth Calculus10 participants
Left-posterior Denture TeethDenture Teeth Calculus20 participants
Left-posterior Denture TeethDenture Teeth Calculus04 participants
Secondary

Denture Teeth Esthetics

Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels, high, little none)

Time frame: 12 months after denture completion

Population: For study participants who completed the 12-month follow-up.

ArmMeasureGroupValue (NUMBER)
Upper DentureDenture Teeth EstheticsDeviation: High1 participants
Upper DentureDenture Teeth EstheticsDeviation: Little2 participants
Upper DentureDenture Teeth EstheticsDeviation: None4 participants
Secondary

Denture Teeth Esthetics

Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels: high, little, none)

Time frame: 6 months after denture completion

ArmMeasureGroupValue (NUMBER)
Upper DentureDenture Teeth EstheticsDeviation: High0 participants
Upper DentureDenture Teeth EstheticsDeviation: Little2 participants
Upper DentureDenture Teeth EstheticsDeviation: None6 participants
Secondary

Denture Teeth Esthetics

Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels: high, little, none)

Time frame: 24 months after denture completion

Population: For study participants who completed the 24-month follow-up.

ArmMeasureGroupValue (NUMBER)
Upper DentureDenture Teeth EstheticsDeviation: High1 participants
Upper DentureDenture Teeth EstheticsDeviation: Little3 participants
Upper DentureDenture Teeth EstheticsDeviation: None2 participants
Secondary

Denture Teeth Esthetics

Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels: high, little, none)

Time frame: 18 months after denture completion

Population: For study participants who completed the 18-month follow-up.

ArmMeasureGroupValue (NUMBER)
Upper DentureDenture Teeth EstheticsDeviation: High0 participants
Upper DentureDenture Teeth EstheticsDeviation: Little1 participants
Upper DentureDenture Teeth EstheticsDeviation: None3 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026