Clinical Assessment of Distal Versus Mesial Single-Retainer Resin Bonded Fixed Partial Denture for Replacement of an Upper Lateral Incisor: (Randomized Clinical Trial).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Survival rate in the term of retention and fracture
研究概览
简要总结
The Intervention Will be All Ceramic Single-retainer Resin Bonded Fixed Partial Denture Using the Upper Canine as Abutment With Minimum Preparation on the Lingual Surface Within the Enamel Providing Maximum Area for the Retainer Bonding, to Replace the Upper Lateral Incisor and Will be Compared With the Control/Comparator Group Which is the All Ceramic Single-retainer RBFPD Using the Upper Central Incisor. The Participants in This Study Will be Recruited by the Researcher From the Clinic of Fixed Prosthodontics Department, Clinic of Orthodontics Department and Clinic of Diagnosis Department, Cairo University Without Any Financial or Non-financial Incentives.
详细描述
The intervention will be all ceramic single-retainer Resin Bonded Fixed Partial Denture using the upper canine as abutment with minimum preparation on the lingual surface within the enamel providing maximum area for the retainer bonding, to replace the upper lateral incisor and will be compared with the control/comparator group which is the all ceramic single-retainer RBFPD using the upper central incisor.
This intervention will be done by one investigator in all study groups who has master degree in fixed prosthodontics with eight years of experience. The intervention will be carried out in the clinic of the department of Fixed Prosthodontics, Cairo University under supervision of PhD holder staff members. The self-adhesive dual cure resin cement will be used for cementation in all groups.
In the first session, the participant will be informed about all steps from the beginning to the end. All participants will be encouraged to maintain good oral hygiene and attend the regular follow up visits and in case of any complain related to the investigated restoration.
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 (Outcomes Assessor)
盲法说明
Statistician
入排标准
- 年龄范围
- 14 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who have unilateral or bilateral missing upper lateral incisor and need to replace them with the following criteria:
- •From 14-30 years old and be able to read and sign the informed consent document.
- •physically and psychologically able to withstand conventional dental procedure
- •Sound or minimally restored abutment with enough enamel surface area for bonding and no periodontal diseases.
- •If the patient had previously undergone orthodontic treatment, a stabilization period of at least 3 months before impression taking.
- •Good oral hygiene.
- •Able to return for follow-up examinations and evaluation.
- •No signs and symptoms of bruxism.
排除标准
- •Pregnant women
- •Increased overbite
- •Bruxism, clenching or abnormal habits like nail or pencil biting that create occlusal forces
- •Any developmental anomaly affecting the enamel of upper central incisor or canine
- •Uncontrolled caries and periodontal disease and uncooperative patients. 6- Medically unfit for dental treatment and follow up.
结局指标
主要结局
Survival rate in the term of retention and fracture
时间窗: 12 months
The retention and fracture of the restoration of the two groups will be measured using the Modified United States Public Health Service (USPHS) criteria. Regarging retention (Alpha= no debonding, Charlie= debonding), while fracture will scored as (Alpha= no fracture, Bravo=Small chipping, but clinically acceptable, Charlie= Failure due to bulk fracture).
次要结局
- Abutment tooth mobility and patient's satisfaction(12 months)
- Abutment tooth mobility and patient's satisfaction(12 months)
研究者
mohamed abdalla belead
principle investigator
Cairo University