One-Year Clinical Evaluation of a Fluoride, Calcium and Phosphate-Releasing New Bioactive Material Versus a Fluoride-Releasing Hybrid Restorative Material in Cervical Lesions: A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Marginal adaptation
研究概览
简要总结
- This study will be conducted to evaluate and compare the clinical performance of fluoride, calcium, and phosphate-releasing new bioactive material versus a fluoride-releasing hybrid restorative material in cervical lesions for one-year follow-up.
- The clinical evaluation will be done using modified USPHS criteria at baseline,3,6,9 and 12 months.
详细描述
two groups of 30 patients will receive cervical restorations by using calcium and phosphate releasing hybrid restorative material (Activa™ Presto, Pulpdent®, USA), or a fluoride-releasing hybrid restorative material (Giomer, Shofu, Japan). Then these restorations will be evaluated at baseline, 3 months, 6 months, 9 months, and 12 months according to modified USPHS criteria in terms of marginal adaptation, Marginal discoloration, recurrent caries, retention, surface texture, and Post-operative sensitivity.
- Examination and selection of all patients will be done according to inclusion and exclusion criteria.
- A class v cavity will be prepared after local anesthesia has been given as required. Rubber dam isolation followed by the placement of restorative material according to the randomization sequence.
- For the intervention: selective etching to enamel and universal bond agent to all the cavity will be applied first, followed by filling of the cavity with fluoride, calcium, and phosphate-releasing new bioactive material (Activa™ Presto, Pulpdent®, USA) using a 19-gauge applicator tip on the syringe and light-curing for 20 seconds between each 2mm layer.
- For the control group: selective etching to enamel and universal bond agent to all the cavity will be applied first, followed by filling of the cavity with fluoride-releasing hybrid restorative material (Giomer, Shofu, Japan) and will be light polymerized using a light-emitting diode (LED) light-curing unit for 10 seconds between each 2mm layer.
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
The participants will be blinded to the technique used since the patient will attend the same number of visits and he can not differentiate between different restorative materials.
The operator cannot be blinded because of the difference in the application procedures of each restorative material.
The outcome assessor will be blinded to the material used. This will be performed by M.S. and Y.H. Therefore the assessors mustn't be included in the preclinical assessment.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •a)Inclusion Criteria of participants:
- •Male or female gender.
- •Only co-operative patients will be approved to participate in the trial.
- •Medically free adult patients.
- •The age range of the patients is 18-40 years. b)Inclusion Criteria of teeth:
- •Small to moderate cervical lesion.
- •Vital upper or lower teeth with no signs of irreversible pulpitis.
- •Caries extension shouldn't exceed mesiodistal width and inciso(occluso)-gingival length not exceed incisal (occlusal) one third.
排除标准
- •a)Exclusion criteria of participants:
- •Allergic history concerning methacrylates
- •Pregnancy
- •Heavy smoking; xerostomia
- •Lack of compliance
- •Patients with disabilities.
- •Patients having systemic diseases or severe medically compromised.
- •Patients with severe bruxism, clenching, or temporomandibular joint disorders.
- •b)Exclusion criteria of the teeth:
- •Deep defects (close to the pulp, less than 1 mm distance).
- •Periapical pathology or signs of pulpal pathology.
- •Possible prosthodontic restoration of teeth.
- •Heavy occlusion and occlusal contacts or history of bruxism.
- •Pulpitis, non-vital or endodontically treated teeth.
- •Sever periodontal affection.
结局指标
主要结局
Marginal adaptation
时间窗: one year
The restoration will be clinically assessed by visual inspection and explorer. Restorations will be given a score using modified USPHS criteria: Alfa: Closely adapted, no visible crevice Bravo: Visible crevice, the explorer will penetrate Charlie: Crevice in which dentin is exposed
次要结局
- Marginal Discoloration(one year)
- postoperative sensitivity(one year)
- Retention(one year)
- Secondary caries(one year)
- surface texture(one year)
研究者
Nourhan Khaled Mohamed Samir
Resident at Conservative department
Cairo University