Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00223405
Status:
COMPLETED
Last Update Posted:
2016-11-22
First Post:
2005-09-13
Brief Title:
Analysis of Enamel Wear Against Ceramic Restorations
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
The University of Texas Health Science Center at San Antonio
Study Overview
Official Title:
Analysis of Clinical Wear Patterns of Tooth Enamel and Ceramic Restorations as a Function of Particle Size Inter-Particle Spacing and Fracture Toughness of Ceramic Crystals
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1 To characterize the microstructure fracture toughness particle size of ceramic and inter-particle spacing of three ceramic materials
2 To test the hypothesis that lower fracture toughness of glass andor crystal phase in ceramics reduce wear damage of enamel
3 To test the hypothesis that smaller sized crystals reduce wear damage of enamel
4 To test the hypothesis that larger inter-particle spacing reduces wear damage of enamel
5 To test the hypothesis that equivalent wear patterns exist in all directions between enamel versus enamel and ceramic versus enamel
6 To test the hypothesis that bite force does not correlate with wear rates
7 To test the hypothesis that salivary flow does not correlate with wear rates
8 To test the hypothesis that a greater amount of wear is not associated with a loss in vertical dimension of occlusion
9 To test the hypothesis that a greater amount of wear does not correlate with secondary cementum deposition as part of the passive eruption process
10 To test the hypothesis that maximum wear occurs early and wear rates level off within the first two years
11 To test the hypothesis that in vitro wear analysis does not correlate with in vivo wear measurements
2 To test the hypothesis that lower fracture toughness of glass andor crystal phase in ceramics reduce wear damage of enamel
3 To test the hypothesis that smaller sized crystals reduce wear damage of enamel
4 To test the hypothesis that larger inter-particle spacing reduces wear damage of enamel
5 To test the hypothesis that equivalent wear patterns exist in all directions between enamel versus enamel and ceramic versus enamel
6 To test the hypothesis that bite force does not correlate with wear rates
7 To test the hypothesis that salivary flow does not correlate with wear rates
8 To test the hypothesis that a greater amount of wear is not associated with a loss in vertical dimension of occlusion
9 To test the hypothesis that a greater amount of wear does not correlate with secondary cementum deposition as part of the passive eruption process
10 To test the hypothesis that maximum wear occurs early and wear rates level off within the first two years
11 To test the hypothesis that in vitro wear analysis does not correlate with in vivo wear measurements
Detailed Description:
A total of 36 teeth 1 crown per patient needing crowns will be selected with the following acceptance criteria
1 Subjects must be over 18 years of age with good overall health No contraindications to dental treatment must be present
2 Subjects must have overall good dental health with no active tooth decay caries present and no periodontal disease Pocket depth on all remaining teeth must not be more than 4 mm
3 Subjects must have no existing temporomandibular disorder eg clicking popping pain on opening or parafunctional habits eg bruxism clenching
4 Subjects must need a crown on either a second premolar first molar or second molar on any arch Abutment teeth must be restorable and have a crown root ratio of at least 11 Abutment teeth must have a complement of opposing non-restored or minimally restored natural teeth Minimally restored means nothing beyond a Class II amalgam restoration Opposing arch cannot be a full coverage restoration or a partial denture Contralateral tooth must be preferably present
5 Subjects must exhibit good oral hygiene and compliance
6 Subjects must not have any existing condition that could limit the flow of saliva eg saliva flow must be of normal quantity
Baseline data will be collected and will consist of
1 General medical history and physical examination
2 Primary casts taken with polyvinylsiloxane impression material
3 Bite force measurement in Newtons using a gnathodynamometer
4 Pocket depths of abutment teeth must be recorded
5 Periapical radiographs of abutment teeth Radiographs will be taken at the exact position with the use of the longitudinal radiographic analysis LRA technique
6 Vertical dimension measured from the nasion to the lowest point on the chin
7 A saliva sample will be collected to ascertain quality viscosity and quantity The parameters for analysis will be salivary pH buffer capacity secretion mlmin protein mgml phosphate mmoll Ca mvall Na mvall K mvall
A total of 36 teeth will be randomly assigned to receive either a metal-ceramic DSign or an all-ceramic crown IPS Empress2 Eris EXC Randomization will be done through a random number table Teeth will be prepared by two operators Dr Josephine Esquivel-Upshaw and Dr William Rose both from the General Dentistry department Provisional restorations will be made from Integrity Dentsply USA and final impressions will be made with a polyvinylsiloxane material using the two-stage technique Master casts will be mounted in centric relation
A single unit crown will be made from either two types of an all-ceramic material or a metal-ceramic material and cemented with a dual cure resin cement Adjustments will be made with a high-speed handpiece and a fine diamond bur Prior to cementation all adjusted surfaces must be polished or glazed Occlusal surface thickness of the crowns will be measured at baseline
Baseline examination will be performed one week after cementation to ensure that the patient is comfortable with the crown and no further adjustments are needed A polyvinylsiloxane impression will be made of the maxillary and mandibular arches to record the cemented crown and its antagonist arch
The post-cementation casts will be poured with a Type IV gypsum product to enable proper scanning A 3D Laserscanner will be used to scan in the x y and z planes of toothteeth casts made from natural teeth The vertical dimension will be recorded as well as periapical radiographs taken of the abutment teeth
The subjects will be asked to return after six months of cementation Polyvinylsiloxane impressions will once again be made of maxillary and mandibular arches and poured with Type IV stone The antagonist teeth and the crown will be scanned using the 3D Laserscanner Superimposition of baseline image and the six-month image will be performed and the amount of wear in three dimensions calculated mathematically Vertical dimension of occlusion will also be determined by measurement of nasion to the lowest point on the chin and periapical radiographs taken of the restored teeth using the LRA technique This procedure will be repeated every year for the next four years
The amount of wear in microns will be determined for the x y and z axes Data will be subjected to a one-way ANOVA α 005 to determine any significant difference in wear of natural antagonist teeth and the ceramic crowns between baseline and yearly 3D images and also differences in wear between the yearly 3D images Occlusal thickness of restorations will be determined based on the amount of wear calculated Any presence of cracks or fractures will be recorded Correlation of the amount of wear and any changes in vertical dimension and root cementum length will also be determined by comparison of nasion-chin height at different intervals
1 Subjects must be over 18 years of age with good overall health No contraindications to dental treatment must be present
2 Subjects must have overall good dental health with no active tooth decay caries present and no periodontal disease Pocket depth on all remaining teeth must not be more than 4 mm
3 Subjects must have no existing temporomandibular disorder eg clicking popping pain on opening or parafunctional habits eg bruxism clenching
4 Subjects must need a crown on either a second premolar first molar or second molar on any arch Abutment teeth must be restorable and have a crown root ratio of at least 11 Abutment teeth must have a complement of opposing non-restored or minimally restored natural teeth Minimally restored means nothing beyond a Class II amalgam restoration Opposing arch cannot be a full coverage restoration or a partial denture Contralateral tooth must be preferably present
5 Subjects must exhibit good oral hygiene and compliance
6 Subjects must not have any existing condition that could limit the flow of saliva eg saliva flow must be of normal quantity
Baseline data will be collected and will consist of
1 General medical history and physical examination
2 Primary casts taken with polyvinylsiloxane impression material
3 Bite force measurement in Newtons using a gnathodynamometer
4 Pocket depths of abutment teeth must be recorded
5 Periapical radiographs of abutment teeth Radiographs will be taken at the exact position with the use of the longitudinal radiographic analysis LRA technique
6 Vertical dimension measured from the nasion to the lowest point on the chin
7 A saliva sample will be collected to ascertain quality viscosity and quantity The parameters for analysis will be salivary pH buffer capacity secretion mlmin protein mgml phosphate mmoll Ca mvall Na mvall K mvall
A total of 36 teeth will be randomly assigned to receive either a metal-ceramic DSign or an all-ceramic crown IPS Empress2 Eris EXC Randomization will be done through a random number table Teeth will be prepared by two operators Dr Josephine Esquivel-Upshaw and Dr William Rose both from the General Dentistry department Provisional restorations will be made from Integrity Dentsply USA and final impressions will be made with a polyvinylsiloxane material using the two-stage technique Master casts will be mounted in centric relation
A single unit crown will be made from either two types of an all-ceramic material or a metal-ceramic material and cemented with a dual cure resin cement Adjustments will be made with a high-speed handpiece and a fine diamond bur Prior to cementation all adjusted surfaces must be polished or glazed Occlusal surface thickness of the crowns will be measured at baseline
Baseline examination will be performed one week after cementation to ensure that the patient is comfortable with the crown and no further adjustments are needed A polyvinylsiloxane impression will be made of the maxillary and mandibular arches to record the cemented crown and its antagonist arch
The post-cementation casts will be poured with a Type IV gypsum product to enable proper scanning A 3D Laserscanner will be used to scan in the x y and z planes of toothteeth casts made from natural teeth The vertical dimension will be recorded as well as periapical radiographs taken of the abutment teeth
The subjects will be asked to return after six months of cementation Polyvinylsiloxane impressions will once again be made of maxillary and mandibular arches and poured with Type IV stone The antagonist teeth and the crown will be scanned using the 3D Laserscanner Superimposition of baseline image and the six-month image will be performed and the amount of wear in three dimensions calculated mathematically Vertical dimension of occlusion will also be determined by measurement of nasion to the lowest point on the chin and periapical radiographs taken of the restored teeth using the LRA technique This procedure will be repeated every year for the next four years
The amount of wear in microns will be determined for the x y and z axes Data will be subjected to a one-way ANOVA α 005 to determine any significant difference in wear of natural antagonist teeth and the ceramic crowns between baseline and yearly 3D images and also differences in wear between the yearly 3D images Occlusal thickness of restorations will be determined based on the amount of wear calculated Any presence of cracks or fractures will be recorded Correlation of the amount of wear and any changes in vertical dimension and root cementum length will also be determined by comparison of nasion-chin height at different intervals
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 116163 | None | None | None |