Evaluating the Longevity and Safety of Full-coverage Crowns Fabricated With LuxaCrown Over a Period of 5 Years in 25-60 Year Old Indian Population: An Uncontrolled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change of secondary caries
研究概览
简要总结
A single arm non-blinded study is planned to evaluate the durability of the crowns fabricated using a novel composite based material, LuxaCrown (DMG, Germany). The durability of these crowns will be assessed for anatomical form, marginal adaptation, color match, marginal discoloration, surface roughness, secondary caries, pulpal compatibility, plaque index and modified papillary bleeding index with intensive follow up for 2 years (at 1 week, 3rd, 6th, 12th, 18th and 24th month), and then a yearly follow-up for additional 3 years (at 36th, 48th and 60th month).
A total of 50 patients will be selected and one tooth per subject will be included. For the purpose of study only the healthy adult patients with age range of 25 - 60 years who would be requiring Single crown restoration in the permanent anterior / posterior teeth, either due to caries, pulpal involvement or trauma, will be selected. Teeth that require endodontic treatment shall be included in the study only after successful endodontic therapy has been completed by an experienced endodontist. For broken teeth, only the teeth with > 1/2 crown structure remaining or in case of teeth with <1/2 crown structure fractured that can be restored with conventional post and core will be selected. In general, patients with bruxism, or with severe periodontal disease, mobility grade 2 or 3 shall be excluded from the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy adult patients with age range 25 - 60 years
- •Only the patients who would be requiring Single crown restoration in the permanent anterior / posterior teeth will be selected for the purpose of study. Single crowns are usually indicated in either of the following conditions
- •Extensive coronal / structural broken tooth due to caries or trauma
- •Teeth undergone successful endodontic therapy (no signs of failure- asymptomatic, no tenderness on percussion, healthy associated soft tissue)
- •Microdonts
- •Teeth that require endodontic treatment shall be included in the study only after successful endodontic therapy has been completed by an experienced endodontist. The success of the endodontic therapy shall be evaluated using the standardized clinical and radiographic criteria by the endodontist.
- •Broken teeth with > ½ crown structure remaining will be selected.
- •Broken teeth with < ½ crown structure remaining will also be selected provided they can be restored with a crown after a conventional Post and core.
- •Patients with good Occlusal Contact will be selected.
- •Patients who would be giving the Signed Informed Consent shall only be enrolled for the study.
- •Only the teeth showing mobility grade 0 and 1 as per Miller's Criteria shall be selected for the purpose of study.
排除标准
- •Patients showing signs of bruxism shall not be selected. History of bruxism and wear facets will be checked for ruling out the bruxism habit.
- •Patients with severe periodontal disease, that involves all teeth or tooth indicated for crown fabrication shall not be included in the study.
- •Any clinical or radiographic sig or symptom indicative of periapical or furcation involvement.
- •If the tooth indicated for crown fabrication depicts a mobility grade 2 or 3 as per Miller's criteria, it shall be excluded from the study.
- •History of any systemic illness, pregnancy or history of allergy to dental fillings/materials shall also be excluded.
- •Teeth with fracture of crown en-masse (Ellis Class VIII) fracture or which are badly mutilated such that a very minimal or No coronal structure is remaining will be excluded.
- •Hypoplastic / malformed teeth will not be selected for the purpose of study.
研究组 & 干预措施
LuxaCrown
干预措施: LuxaCrown (Device)
结局指标
主要结局
Change of secondary caries
时间窗: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Secondary caries will be assessed and scored according to Dijken modification of USPHS criteria.
Change of wear
时间窗: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
The severity of attrition will be scored as described by Pergamalian
Change of marginal discoloration
时间窗: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Marginal discoloration will be assessed and scored according to Dijken modification of USPHS criteria.
Change of anatomical form
时间窗: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Anatomical form will be assessed and scored according to Dijken modification of USPHS criteria.
Change of marginal adaptation
时间窗: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Marginal adaptation will be assessed and scored according to Dijken modification of USPHS criteria.
Change of color match
时间窗: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Color match will be assessed and scored according to Dijken modification of USPHS criteria.
Change of surface roughness
时间窗: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Surface roughness will be assessed and scored according to Dijken modification of USPHS criteria.
Change of plaque index
时间窗: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Plaque index will be assessed and scored according to Sillness and Loe, 1964
Change of pulpal compatibility
时间窗: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Assessment of the pulpal response by the FDI criteria
Change of modified papillary bleeding index
时间窗: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Measurement and scoring of modified papillary bleeding index (Barnett et al.)
次要结局
- Change of patient satisfaction(1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months)