Clinical Evaluation of a Low Shrinkage Flowable Resin Composite in Adult Teeth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Clinical Performance by VAS (Pain Scale)
研究概览
简要总结
Study hypothesis: a new, low polymerization stress flowable composite performs no differently to a conventional, highly filled composite filling material when used as a restorative in small cavities in back teeth.
Study will evaluate the clinical performance of a low shrinking flowable composite filling material, compared with a conventional, highly filled composite restorative when used to permanently fill small cavities in molar and premolar teeth in adult patients.
详细描述
The study will evaluate clinical performance of a low shrink flowable composite filling material and compare it with a conventional, highly filled composite. The study materials will be used to restore small cavities in molar and premolar teeth in adult patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19 years or older
- •must give written consent
- •be in good general health
- •be available for required follow-up visits
- •have at least 28 teeth
排除标准
- •has rampant, uncontrolled caries
- •has advanced, untreated periodontal disease
- •heavy use of smoking tobacco (2 packs or equivalent a day)or chewing tobacco
- •has systemic or local disorders that contra-indicate the dental procedures needed in this study
- •has evidence of xerostomia
- •has evidence of severe bruxing or clenching, or in need of Temporomandibular Joint (TMJ) related therapy
- •is pregnant at time of screening or tooth restoration
- •has known sensitivity to acrylates or related materials
结局指标
主要结局
Clinical Performance by VAS (Pain Scale)
时间窗: baseline, 6, 12 and 24 months
Sensitivity to cold was measured by applying a cotton pellet soaked with pulp vitality refrigerant spray (Endo Ice, Coltene/ Whaledent, Cuyahoga Falls, OH, USA) to the tooth for three seconds. Sensitivity to biting was measured by having the patient bite on a cotton roll for five seconds. After each test, the subject was asked to place an ''X'' on a 10-mm line labeled ''1'' on the left and ''10'' on the right. Patients were told that a ''10'' represents the worst pain they can imagine (ie, childbirth, major surgery, or kidney stone) and that ''1'' represents no sensation at all.
Clinical Performance by Cvar & Ryge Scores
时间窗: baseline, 6, 12 and 24 months
Clinical performance reported on 6 parameters as the % of teeth with perfect scores ("A" rating). Cvar \& Ryge scores measure 6 parameters: Anatomic form (rated A,B= satisfactory, C=unsatisfactory); Color Match (A=match, B=mismatch, but within normal, C=mismatch outside normal); Marginal Adaptation (A=no visible crevice, B=no exposure of dentin, C=defect to enamel-dentine junction, D= fracture, missing); Marginal Discoloration (A=none, B= marginal discoloration, C=marginal discoloration to pulpal direction); Surface Integrity (A=smooth, B=slight rough, C=Pitted, D=fracture)'Secondary caries (A=none, D=present).
次要结局
未报告次要终点