Evaluation of the Clinical Performance of a Highly Filled Flowable Composite in Class III Cavity Restorations: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Retention alpha for at least %90 of the restorations
研究概览
简要总结
The aim of this study was to evaluate the 12-month clinical performance of a highly filled flowable composite resin in anterior teeth.
The study will include healthy individuals over the age of 18 who apply to the Department of Restorative Dentistry, Faculty of Dentistry, Hacettepe University, for the treatment of Class III lesions in their anterior teeth. After explaining the purpose and procedures of the study, participants will be asked to sign an informed consent form if they agree to participate. Gender, age, and the tooth numbers to be treated will be recorded. A total of 100 maxillary anterior incisor teeth in 50 patients will be treated, ensuring a balanced distribution of treated teeth between the right and left arches.
A split-mouth design will be used, whereby at least two teeth per patient will be included in the study, and each of the two restorative materials will be applied to one tooth. The allocation of restorative material to each tooth will be randomized. Before the procedure, the names of both materials will be written on separate papers, placed into envelopes, and a member of the auxiliary staff will randomly select one envelope during the restoration stage to ensure randomization.
The sample size was calculated using the Sealed Envelope software program (Sealed Envelope Ltd., 2012). It was assumed that 95.0% of the restorations would remain intact over 12 months, with α = 0.05, power = 80%, and an expected 10% difference between groups. Based on these parameters, the required sample size was calculated as 33. Considering the possibility of patient dropout during the study, 50 teeth per group were included.
详细描述
Objective The objective of this randomized controlled clinical trial is to evaluate the 12-month clinical performance of a highly filled flowable composite resin in the restoration of Class III lesions in anterior teeth.
Study Design and Participants This study will be conducted at the Department of Restorative Dentistry, Faculty of Dentistry, Hacettepe University. A total of 50 healthy adult participants (≥18 years) who present with at least two Class III lesions in their maxillary anterior teeth will be included. The inclusion process will involve verbal and written explanations of the study protocol, and participants who provide written informed consent will be enrolled.
Patient demographic information, including age and gender, as well as the numbers of the teeth to be treated, will be recorded. In total, 100 maxillary anterior teeth (2 per patient) will be restored, with a balanced distribution between the right and left dental arches.
A split-mouth design will be used, where each patient will receive two restorations, each using a different composite resin. The allocation of materials to each tooth will be randomized by sealed-envelope selection to ensure blinding during the restorative procedure.
Sample Size Calculation The required sample size was determined using the Sealed Envelope software (Sealed Envelope Ltd., 2012). Assuming a restoration survival rate of 95% over 12 months, a significance level (α) of 0.05, 80% statistical power, and a 10% expected difference between groups, the minimum required sample size was calculated as 33 restorations. To account for potential dropouts, 50 teeth per group were included.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be at least 18 years of age.
- •Have at least two Class III lesions in maxillary anterior teeth.
- •Lesions must be classified as D2 (involving half the dentin thickness) and must not extend to D3 (three-quarters dentin depth).
- •Must provide signed informed consent.
- •Be physically capable of attending all follow-up appointments.
- •Have no periapical pathology in the involved teeth.
排除标准
- •Presence of severe periodontal disease affecting the tooth planned for restoration.
- •Absence of an opposing tooth or lack of occlusal function involving the affected tooth.
- •Subgingival extension of the lesion beyond the cervical margin.
- •Lesions limited to enamel without dentinal involvement.
- •Extensive lesions that cannot be restored with a direct restorative technique.
- •Presence of anterior malocclusion affecting tooth positioning or function.
- •Individuals with intellectual disabilities that may impair communication or compliance.
- •Teeth that have been previously restored in the area of interest.
- •Known allergy to methacrylate monomers or methacrylate-based polymers.
- •Patients under the age of 18 or over the age of 64.
研究组 & 干预措施
highly filled flowable resin composite
After etching the enamel with 37% phosphoric acid for 30 seconds, the area will be rinsed with water for 20 seconds and gently air-dried. One layer of adhesive (G2 Bond, GC Corp, Tokyo, Japan) will be applied according to the manufacturer's instructions and polymerized for 10 seconds with a LED light curing unit.The injectable composite resin (G-Aenial Universal Injectable) will be placed similarly in 2 mm increments and light-cured.
干预措施: tooth restoration (Device)
conventional resin composite
After etching the enamel with 37% phosphoric acid for 30 seconds, the area will be rinsed with water for 20 seconds and gently air-dried. One layer of adhesive (G2 Bond, GC Corp, Tokyo, Japan) will be applied according to the manufacturer's instructions and polymerized for 10 seconds with a LED light curing unit. Conventional composite resin (G-Aenial A'chord) will be placed in increments of no more than 2 mm, each layer light-cured.
干预措施: tooth restoration (Device)
结局指标
主要结局
Retention alpha for at least %90 of the restorations
时间窗: 1 year
The primary endpoint was the assessment of restoration retention and absence of material fracture, evaluated according to the FDI World Dental Federation clinical criteria. A restoration was considered successful if it received a score of 1 (excellent) or 2 (good) and remained in place without the need for repair or replacement.
次要结局
未报告次要终点
研究者
Buse Uygunöz
research assistant
Hacettepe University