Multicentre Randomized Controlled Trial of AI-driven Digital Smile Design vs Conventional Digital Wax-up: Measuring 3-Year Veneer Survival, Color Stability and Cost-Utility
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- 3 year clinical survival of anterior ceramic veneers ( measured by absence of debonding, fracture or loss)
研究概览
简要总结
this multicentre randomised controlled trial compared the clinical performance , colour stability and cost utility of AI-driven digital smile design (DSD) versus conventional digital wax for anterior ceramic veneers. a total of 76 patients were enrolled across two sties in Mumbai and Ahmednagar . participants were followed for 36 months post treatment to evaluate veneer survival, aesthetic stability , patient satisfaction, and quality of life improvement using OHIP-14. the trial concluded in June 2025 and demonstrated comparable veneer survival in both groups with significantly higher patient satisfaction and cost effectiveness in the AI-DSD group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •systemically healthy adults aged 18-55 years.
- •requirements for 4-8 maxillary anterior veneers for aesthetic reasons.
- •no prior restorations on anterior teeth in aesthetic zone.
- •good periodontal health.
- •singed informed consent obtained.
排除标准
- •presence of parafunctional habits.
- •smokers or tobacco users.
- •history of trauma or root canal therapy in anterior teeth.
- •pregnant or lactating mothers.
- •poor oral hygiene or untreated periodontal disease.
- •allergies to ceramic materials or bonding agents.
结局指标
主要结局
3 year clinical survival of anterior ceramic veneers ( measured by absence of debonding, fracture or loss)
时间窗: 3 year clinical survival of anterior ceramic veneers ( measured by absence of debonding, fracture or loss)
次要结局
- colour stability of veneers ( measured with spectrophotometer )(at final review ( 36 months))
- patient satisfaction score using VAS ( visual analogue scale)(at final review ( 36 months))
- oral health impact profile ( OHIP-14 aesthetic sub scale improvement)(pre treatment and 36 months post treatment)
- incremental cost utility ratio ( ICUR) per satisfaction point gained(at final review ( 36 months))
研究者
Dr Sagar Abichandani
Silverline Dent and Care Solutions Pvt. Ltd