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临床试验/CTRI/2026/01/102245
CTRI/2026/01/102245尚未招募3 期

Comparative Clinical Evaluation of Layered Zirconia and Zirconia-Reinforced Lithium Disilicate Crowns: A Randomized Controlled Trial

未提供1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年2月15日最近更新:

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 analysisclinical 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

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr Prasad N Masske

PIMS-DU Loni

研究点 (1)

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