Comparative Clinical Evaluation of Layered Zirconia and Zirconia-Reinforced Lithium Disilicate Crowns: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
研究概览
简要总结
Aim
To compare the Clinical Evaluation of Layered Zirconia and Zirconia-Reinforced Lithium Disilicate crowns in posterior and anterior restorations over a period of two years.
OBJECTIVES
To compare the survival ratesinLayered Zirconia and Zirconia-Reinforced Lithium Disilicate crowns**.**
To compare the fracture resistancein Layered Zirconia and Zirconia-Reinforced Lithium Disilicate crowns.
To compare the aesthetic performancein Layered Zirconia and Zirconia-Reinforced Lithium Disilicate crowns and
To compare thepatient satisfaction of layered zirconia vs. zirconia-reinforced lithium disilicate Zr-LD crowns in posterior and anterior restorations over a 2 year period.
STUDY DESIGN
Type Prospective, triple-blind, randomized controlled trial RCT
Participants97 patients requiring single-unit posterior or anterior crowns will be allocated randomly and allocation concealment will be done.
Groups Group 1 Layered zirconia crowns zirconia core with veneering ceramic
Group 2 Zirconia-reinforced lithium disilicate monolithic crowns
Follow-up 6 months, 1 year, 2 years.
Inclusion Criteria
Adults (18–60 years) requiring single-unit posterior or anterior crowns with written consent (Annexure I)
Adequate occlusal clearance for material thickness
Good oral hygiene and periodontal health
No history of parafunctional habits (e.g., bruxism)
Exclusion Criteria
Severe bruxism or clenching
Patients withgingivitis and periodontitis
Heavy occlusal loads or malocclusion
Patients with systemic conditions affecting healing (e.g., uncontrolled diabetes, osteoporosis)
History of allergic reactions to ceramic materials
Outcome Measures
Primary Outcomes
Fracture/chipping rate of the crowns
Survival rate over the study period
Marginal adaptation and retention
Secondary Outcomes
Patient satisfaction measured using a Visual Analog Scale
Colour stability and translucency over time
Wear resistance and antagonist tooth wear
Periodontal health around restorations gingival index, plaque index
METHODOLOGY
Sample size calculationwill be done using Statulator,a sample calculator.
Sample size is 97based on with 0.95 level of confidence, 0.5 expected proportion and 0.1 absolute value of margin of error.
Calibration and training of the observerwill be done for reliability and validity of the questionnaires
Pilot studywillbe done on 10 percent of the total sample size
Patients will be randomly assigned to receive either a layered zirconia or a zirconia-reinforced lithium disilicate crown.
Patients, evaluators and statistician will be blinded to the material used. The prosthodontist performing the restorations will not be blinded due to procedural requirements.
Allocation concealment Patients will be allocated in two groups.
Clinical Procedures
Standardized tooth preparation (1.5–2.0 mm occlusal reduction, chamfer margin)
Conventional impressions recorded and compared
Crowns cemented using standardized adhesive protocols
Follow-Up Assessments:
At 6 months, 1 year, 2 years.
Evaluations will include radiographic analysis, clinical examination, and patient-reported outcomes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Adults 18–60 years requiring single-unit posterior or anterior crowns with written consent Adequate occlusal clearance for material thickness Good oral hygiene and periodontal health No history of parafunctional habits.
排除标准
- •Severe bruxism or clenching Patients with gingivitis and periodontitis Heavy occlusal loads or malocclusion Patients with systemic conditions affecting healing e.g. uncontrolled diabetes, osteoporosis History of allergic reactions to ceramic materials.
研究者
Dr Prasad N Masske
PIMS-DU Loni
