Clinical Evaluation of 3M(TM) Filtek(TM) Supreme Flowable Composites for Class IV and Veneers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Survival of treated site over 24 months
研究概览
简要总结
This clinical study aims to evaluate the clinical performance of 3M™ Filtek™ Supreme Flowable Composite in class IV and veneer indication. Follow-ups of 7 days, 6, 12, and 24 months will be conducted following an Fédération Dentaire Internationale (FDI) modified score (2023). A minimum of 50 Class IV and 25 veneers will be included in the evaluation. Research data and pictures will be provided for each patient pre-op and at 7 days (baseline, 6 months, 12 months and 24 months. Evaluation will be conducted by two calibrated evaluators different from the operator according to FDI clinical criteria.
详细描述
Resin composites have been used for anterior restorative solutions as they offer a variety of shades and opacities, reproducing the natural structure correctly. This field in dentistry is increasing as an option for past ceramic restorations, making them accessible and affordable for patients.
The conservative aspect of the adhesive resin composite restorations helped increase the indications for this procedure. Cosmetic contour, also named "no-prep" composite veneers, joined the traditional class III, IV, and V cavities as common indications.
Regular paste composites, used in many layers, are the most adequate option as technique treatment.
Different layers, with specific shades and many levels of opacity/translucency, are combined to reproduce the natural characteristics of teeth. This helps control the shape and dimension of the restoration desired. Nevertheless, the time required for a proper restoration with an esthetic outcome and the need for highly trained skills are the drawbacks for most clinicians.
Flowable consistency composites were developed with some goals to be achieved, such as better adaptation to the cavity, especially in posterior teeth. Additional advantages were a more uncomplicated technique and preventing the resin composite from sticking to the instrument. It has been proved to provide a low elastic modulus layer as a resilient liner before the regular consistency composite restoration. For anterior teeth, flowable composites have been used in clinical evaluations for class V cavities with comparative outcomes concerning regular consistency materials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 -75 years old
- •must be willing and able to provide informed consent to participate in the study
- •must be available for the required post-operative follow-up study visits
- •must be in good general health
- •must be in good oral health hygiene (FMPS < 20%)
- •have at least 6 anterior maxillary teeth
- •Central and lateral incisors with class IV or Veneer indications. Veneers will be performed exclusively with its contralateral teeth (pairs).
排除标准
- •Single tooth veneers
- •Periodontal disease
- •Pulpal diseases
- •Occlusal dysfunctions (end-to-end bite)
- •Lack of occlusal stability
- •Missing posterior teeth, affecting the occlusal distribution
- •Study tooth, adjacent tooth, or opposing tooth with mobility > grade 2 using the Miller's tooth mobility index
- •Systemic or local disorders that contra-indicate the dental procedures needed in this study
- •Rampant, uncontrolled caries
- •Heavy use of smoking tobacco (1 pack or equivalent a day) or chewing tobacco
- •Evidence of xerostomia
- •Evidence of severe bruxing or clenching, or in need of Temporomandibular Joint (TMJ) related therapy
- •Known allergic reaction and/or sensitivity to research materials being used
- •Condition or history of chronic use of anti-inflammatory, analgesic (pain), and/or mind altering drugs for medical (including psychiatric) and pharmacotherapeutic therapies that might alter the perception of pain
- •Tooth surface loss (attrition, erosion, abrasion, or abfraction) on study tooth or adjacent teeth that could impact the perception of pain.
- •Taking part in a clinical evaluation of any other dental material
- •In the opinion of the Investigator, unsuitable for enrollment in the study for reasons other than those specified in the above exclusion criteria
- •Pregnant at the time of enrollment or procedure visit (determined by urine pregnancy test).
结局指标
主要结局
Survival of treated site over 24 months
时间窗: 24 months
Primary site survival will be based off of an Modified FDI criteria score greater or equal to 4.
次要结局
- Esthetic Properties evaluation(24 months)
- Functional Properties evaluation(24 months)