Clinical and Radiographic Comparison of Symphyseal and Parasymphyseal Single Implant Versus Two Implants in Complete Mandibular Overdentures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in the plaque index
研究概览
简要总结
This study aimed to compare the use of single implants in the symphyseal and parasymphyseal, and two implants were inserted in the canine area bilaterally to assist mandibular complete overdentures regarding clinical evaluation, marginal bone loss, and masticatory efficiency. The null hypothesis was that there was no statistically significant difference in clinical evaluation, marginal bone loss, and masticatory efficiency among single symphyseal implants, single parasymphyseal implants, and two-implant-assisted complete mandibular overdentures.
详细描述
This randomized, controlled clinical trial compared the symphyseal and parasymphyseal single implants versus two implants in complete mandibular overdentures. Fifteen completely edentulous male patients (50-65 years) were chosen and randomly grouped into three equal groups (five patients in each) according to the position and number of the received implants to assist mandibular complete overdentures. Group I: single median implant. Group II: single parasymphyseal implant. Group III: two implants were inserted in the canine area bilaterally. After three months of osseointegration, the lower denture was transformed into an implant-assisted complete mandibular overdenture. Clinical observations were documented on the day of loading, three, six, and nine months later for each implant. Follow-up CBCT scans were performed to assess marginal bone loss on the day of loading, six and twelve months later. The masticatory efficiency evaluation was conducted one month and three months after loading.
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
- None
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •patients with a class I Maxillo-mandibular jaw relationship
- •patients with residual ridges had normal morphology, were free from severe bony undercuts or flabby tissue, and were covered by firm mucoperiosteum.
- •A cone beam CT of the lower arch was made to detect the presence of pathological lesions, remaining roots, or impacted teeth in the arch and evaluate both bone quality and quantity, especially in the area of interest
排除标准
- •patients with current chemotherapy or radiotherapy, bleeding disorders, uncontrolled diabetes
- •patients with a history of drug therapy that interferes with bone resorption or deposition (e.g., the prolonged use of glucocorticoids, antiresorptive medications, selective serotonin reuptake inhibitors, and proton-pump inhibitors),
- •Those with any physical reasons that could affect follow-up, psychiatric problems, heavy smokers, drug or alcohol addicts, immunocompromised patients, abnormal jaw relationship, inadequate inter arch space.
- •patients with temporomandibular disorders and para-functional habits (e.g., bruxing and clenching).
结局指标
主要结局
Change in the plaque index
时间窗: The plaque index was documented at follow-up visits on the day of loading, three, six, and nine months later for each implant.
The presence and amount of plaque were determined at the four sites around the implant (mesial, distal, buccal, and lingual) and scored from zero to three. Grade 0: No plaque by probing. Grade 1: film of plaque detected by probing. Grade 2: Visible plaque with the naked eye. Grade 3: abundant soft material in the sulcus, mucosal margin, and adjacent implant surface.
Change in the pocket depth
时间窗: The pocket depth was documented at follow-up visits on the day of loading, three, six, and nine months later for each implant.
The pocket depth was measured by inserting a graduated plastic periodontal probe between the oral sulcular epithelium and the implant with minimal pressure at the midpoint of the four surfaces. The distance from the bottom of the sulcus to the mucosal margin was measured and recorded to the nearest millimeter; the mean of four readings was considered the pocket depth for this group at the chosen time
Change in the bleeding index
时间窗: The bleeding index was documented at follow-up visits on the day of loading, three, six, and nine months later for each implant.
The bleeding index was assessed for the four surfaces while measuring the pocket depth if the bleeding was visible after probing within 20 seconds. It is typically scored as 0 (no bleeding), 1 (bleeding point), 2 (single line of blood), or 3 (heavy or profuse bleeding). The mean of four readings was considered the bleeding index for this group at the chosen time
Change in bone level around implant
时间窗: Immediately after loading, six months, and twelve months later
Calculating average bone height involves dividing the sum of buccal, lingual, mesial, and distal bone height by 4. The real bone loss can be calculated by subtraction from the implant length
Change in the masticatory efficiency
时间窗: The masticatory efficiency was documented at follow-up visits one month and three months after the overdenture insertion
The masticatory efficiency was assessed when the patient ate three different types of food (carrot, apple, and banana) with varying degrees of hardness, cut into standardized pieces (1 cm cube each). The collected data included the following measurements: the chewing stroke count before the first swallow, the chewing stroke count until the oral cavity is empty of food, the count of swallows until the oral cavity is empty of food, the time estimated in seconds until the first swallow, and the time estimated in seconds until the oral cavity is empty of food.
次要结局
未报告次要终点
研究者
Ahmed Ezzat Ahmed Al-Gazzar
Principal investigator
Al-Azhar University