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临床试验/NCT00223405
NCT00223405已完成不适用

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

The University of Texas Health Science Center at San Antonio1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2003年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
1
主要终点
wear of the opposing enamel will be measured yearly for four years

研究概览

简要总结

  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 and/or 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

详细描述

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, (e.g. clicking, popping, pain on opening) or parafunctional habits (e.g. 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 1:1. 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; e.g. 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 (ml/min), protein (mg/ml), phosphate (mmol/l), Ca (mval/l), Na (mval/l), K (mval/l).

A total of 36 teeth will be randomly assigned to receive either a metal-ceramic (D'Sign) 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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects needing a crown on a posterior tooth that is opposed by a natural tooth.

排除标准

  • Subjects must be over 18 years of age with good overall health. No contraindications to dental treatment must be present.
  • 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.
  • Subjects must have no existing temporomandibular disorder, (e.g. clicking, popping, pain on opening) or parafunctional habits (e.g. bruxism, clenching)
  • 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 1:
  • 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.
  • Subjects must exhibit good oral hygiene and compliance.
  • Subjects must not have any existing condition that could limit the flow of saliva; e.g. saliva flow must be of normal quantity.

结局指标

主要结局

wear of the opposing enamel will be measured yearly for four years

时间窗: up to 4 years

次要结局

  • improved function of crown(uo to 4 years)
  • wear of ceramic in vivo(up to 4 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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