Does a Highly Filled Injectable Resin Composite Work Better Alone or in Combination With a Nanohybride Resin Composite? A Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Functional properties score
研究概览
简要总结
This is a double blinded, randomized clinical study that evaluated the performance of a high filled injectable resin composite in polydiastema . The polydiastema disorders will be restored with high filled injectable resin composite (G'aenial Injectable Universal ) or anterior composite resin (G-aenial A'chord ). Restorations will be evaluated after 12 months according to FDI criteria and the data will be analyzed.
详细描述
: The aim of this study was to comparatively evaluate the clinical performance of a high filled injectable resin composite with an anterior composite resin (G-aenial A'chord) in polidaiastemas.
Participants who are 18 years of age or older and healthy, and who have applied to the Restorative Dentistry Department of Hacettepe University Faculty of Dentistry to receive treatment for polidiastema disorders on their front teeth will be included in the study. After explaining the purpose and conditions of the study, they will be asked to sign an informed consent form. The gender, age, and tooth numbers of the participants to be treated will be recorded. 240 upper incisors of 60 patients will be treated, with attention paid to the balanced distribution of teeth in the right and left arches...Data were will be analyzed with Chi- Square, Fisher's Exact Test, Mann U tests
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Polydiastema should be such that the mesial, distal and buccal surfaces of the tooth are included in the restoration.
- •2. The patient has polydiastema in at least teeth 12, 11, 21 and 22
- •3. The patient does not have a systemic disease that would prevent restorative treatment.
- •4. The patient voluntarily signs the informed consent form
- •5. The patient does not have a physical disability that may prevent him/her from coming for a check-up.
- •6. The patient does not have a history of spontaneous pain in the teeth to be included.
- •7. The patient's teeth are alive
- •8. The patient does not have any periapical pathology in the relevant tooth.
- •9. The patient's tooth to be included in the study must be in a position to be restored by direct method.
- •10. The patient is between the ages of 18-35
- •11. The patient has class 1 and class 2 bite
排除标准
- •• 1.Participant must be under 18 years of age or over 35 years of age
- •2. The participant has poor oral hygiene
- •3. The participant has systemic disorders that may prevent regular attendance at treatment and control appointments.
- •4. The participant has parafunctional habits such as clenching/grinding and biting foreign objects.
- •5. Previous diastema closure or reshaping has been performed on the relevant teeth.
- •6. Teeth whitening has been performed on the relevant teeth within the last week.
- •6. Having severe periodontal problems in the relevant tooth
- •7. The relevant tooth has previously been restored due to caries,
- •8. The relevant tooth functions as a removable prosthesis support
- •9. Teeth undergoing orthodontic treatment
- •10. Finding the participant's breakeven and class 3 closure
研究组 & 干预措施
Injectable
G-aenial Injectable (high filled injectable resin composite) group This study planned to investigate the clinical performance of G-aenial Injectable Universal (high filled ınjectable resin composite) in the treatment of anterior polydiastema disorders. This arm of the study is the group whose effectiveness was investigated. The results will be evaluated by comparing with a traditional anterior resin composite in terms of functional, biological and aesthetic properties.
干预措施: Highly Filled Injectable Composite (G-ænial Universal Injectable, GC Corp., Tokyo, Japan) (Device)
Combine
Restorations performed with a combined approach using a 1-mm palatal layer of nanohybrid composite resin (G-ænial A'Chord) followed by the injection of highly filled flowable composite resin (G-ænial Universal Injectable) guided by the PVS index.
干预措施: Nanohybrid Composite (G-ænial A'Chord, GC Corp., Tokyo, Japan) (Device)
Combine
Restorations performed with a combined approach using a 1-mm palatal layer of nanohybrid composite resin (G-ænial A'Chord) followed by the injection of highly filled flowable composite resin (G-ænial Universal Injectable) guided by the PVS index.
干预措施: Highly Filled Injectable Composite (G-ænial Universal Injectable, GC Corp., Tokyo, Japan) (Device)
Conventional
This group will serve as a "control". G-aenial Universal Injectable (high filled ınjectable resin composite) restorations will compare with the "G- Aenial A'chord" anterior resin composite restorations.
干预措施: Nanohybrid Composite (G-ænial A'Chord, GC Corp., Tokyo, Japan) (Device)
结局指标
主要结局
Functional properties score
时间窗: 1 year
The primary factor for determining the clinical performance of a restorative material is the Functional properties. Visual tactile examination tools will be used for evaluating restorations according to FDI criteria by two experienced researchers at 1- week 6-, 12- months. The functional properties are scored as 1- clinically excellent, 2- clinically good, 3-clinically sufficient/satisfactory, 4-clinically unsatisfactory 5-clinically poor (replacement necesessry). Clinically 1, 2 and 3 scores are clinical acceptable but 4 and 5 scores are designated as failure. \[Time Frame: 1 year\]
Esthetic properties score
时间窗: 1 year
The secondary factor for determining the clinical performance of a restorative material is the Esthetic properties. Visual examination will be used for evaluating restorations according to FDI criteria by two experienced researchers at 1- week 6-, 12-months. The Esthetic properties are scored as 1- clinically excellent, 2-clinically good, 3-clinically sufficient/satisfactory, 4-clinically unsatisfactory 5-clinically poor (replacement necesessry). Clinically 1, 2 and 3 scores are clinical acceptable but 4 and 5 scores are designated as failure.
次要结局
未报告次要终点
研究者
Tolunay Aytas
research asistant in restorative dentistry
Hacettepe University