Evaluating the Clinical Performance of a Bioactive Restorative Material in Non-Carious Cervical Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in retention rate
研究概览
简要总结
Evaluating the clinical performance of a bioactive restorative materiel (Cention N) placed in non-carious cervical lesions (NCCLs) with no preparation and 1-step adhesive system or, with preparing a gingival retentive groove and no adhesive system.
详细描述
Cention N is a relatively new restorative material that is known to be the first commercially available bioactive resin composite. The manufacturing company recommends using Cention N with 1-step adhesive system in non-retentive cavities, or with no adhesive system in retentive cavity preparations.
This study was designed to evaluate the clinical performance of this material in non-carious cervical lesions by comparing it to RM-GIC (Fuji II LC).
Information about oral and tooth brushing habits along with detailed information about the characteristics of each NCCL, gingival status, and preoperative sensitivity will be collected for each patient.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Clinical evaluation of restorations will be conducted by two trained and calibrated examiners. All examiners and patients are going to be blinded from group assignment. Allocation concealment will be done by using sequentially numbered, sealed/opaque envelopes.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good general health
- •with at least 20 teeth under occlusion
- •Should have three or more NCCLs which share the characteristics of being deeper than 1 mm, and involve both the enamel and dentin of vital teeth without mobility
排除标准
- •Poor oral hygiene
- •Severe periodontitis
- •Severe bruxism habits
- •Xerostomia
研究组 & 干预措施
Dentin roughness & Gingival retentive groove preparation & Cention N
Dentin roughness:
Using a round carbide bur size 14/16, (H1SEM.204.014 VPE5 or H1SEM.204.016 VPE 5, Komet Dental, Lemgo, Germany) on a low-speed handpiece. (No bevel preparation will be made)
Gingival retentive groove preparation:
Using size-010 round carbide bur (H1SEM.205.010 VPE 5, Komet Dental, Lemgo, Germany) on a low-speed handpiece.
Cention N:
The cavity will be restored using cention N followed by light curing for 10sec (1,000 mW/cm2)
干预措施: Gingival retentive groove preparation (Other)
Dentin Conditioning & RM-GIC
Dentin Conditioning:
After washing and drying -but not desiccating- Dentin Conditioner 20% (GC, Japan) will be applied using a cotton pellet for 20 seconds then rinsed thoroughly and gently dried.
RM-GIC:
RM-GIC (Fuji II LC) will be applied in <2mm incremental layers afterward light-cured for 10 sec (1,000 mW/cm2) per increment to fill the cavity.
干预措施: Dentin Conditioning (Other)
Dentin Conditioning & RM-GIC
Dentin Conditioning:
After washing and drying -but not desiccating- Dentin Conditioner 20% (GC, Japan) will be applied using a cotton pellet for 20 seconds then rinsed thoroughly and gently dried.
RM-GIC:
RM-GIC (Fuji II LC) will be applied in <2mm incremental layers afterward light-cured for 10 sec (1,000 mW/cm2) per increment to fill the cavity.
干预措施: RM-GIC (Other)
1-step adhesive & Cention N
1-step adhesive: A universal adhesive system (Tetric® N-Bond Universal) will be applied on both enamel and dentin and gently scraped for 20 sec, then dispersed with oil-free gentle air stream, then light-cured for 10 sec (1,000 mW/cm2).
Cention N:
The cavity will be restored using cention N followed by light curing for 10sec (1,000 mW/cm2)
干预措施: 1-step adhesive (Other)
1-step adhesive & Cention N
1-step adhesive: A universal adhesive system (Tetric® N-Bond Universal) will be applied on both enamel and dentin and gently scraped for 20 sec, then dispersed with oil-free gentle air stream, then light-cured for 10 sec (1,000 mW/cm2).
Cention N:
The cavity will be restored using cention N followed by light curing for 10sec (1,000 mW/cm2)
干预措施: Cention N (Other)
Dentin roughness & Gingival retentive groove preparation & Cention N
Dentin roughness:
Using a round carbide bur size 14/16, (H1SEM.204.014 VPE5 or H1SEM.204.016 VPE 5, Komet Dental, Lemgo, Germany) on a low-speed handpiece. (No bevel preparation will be made)
Gingival retentive groove preparation:
Using size-010 round carbide bur (H1SEM.205.010 VPE 5, Komet Dental, Lemgo, Germany) on a low-speed handpiece.
Cention N:
The cavity will be restored using cention N followed by light curing for 10sec (1,000 mW/cm2)
干预措施: Cention N (Other)
Dentin roughness & Gingival retentive groove preparation & Cention N
Dentin roughness:
Using a round carbide bur size 14/16, (H1SEM.204.014 VPE5 or H1SEM.204.016 VPE 5, Komet Dental, Lemgo, Germany) on a low-speed handpiece. (No bevel preparation will be made)
Gingival retentive groove preparation:
Using size-010 round carbide bur (H1SEM.205.010 VPE 5, Komet Dental, Lemgo, Germany) on a low-speed handpiece.
Cention N:
The cavity will be restored using cention N followed by light curing for 10sec (1,000 mW/cm2)
干预措施: Dentin roughness (Other)
结局指标
主要结局
Change in retention rate
时间窗: Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year
Rated by Modified United States Public Health Service criteria (USPHS) Alpha: Retained. Bravo: Partially retained. Charlie: Missing.
次要结局
- Change in marginal adaptation(Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year)
- Change in surface texture(Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year)
- Change in secondary caries(Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year)
- Change in restoration fracture(Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year)
- Change in anatomic form(Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year)
- Change in marginal discoloration(Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year)
- Change in patient satisfaction(Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year)
- Change in post-operative sensitivity with stimulation(Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year)
- Change in post-operative sensitivity without stimulation(Baseline: 1 day, follow-ups after 1 week, 1 month, 3 months, 6 months, 9 months, 1 year)