Clinical and Patient- Satisfaction Outcomes During Management of Atrophied Unilateral Distally Extension Maxillary Ridge With Two Different Minimal Invasive Treatment Modalities. 1-year 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
- 40
- 试验地点
- 2
- 主要终点
- Probing depth evaluation
研究概览
简要总结
This study will compare clinical and radio graphic outcomes of two minimally invasive different treatment modalities for atrophied unilateral distal extension maxillary ridges these modalities include
- Medially placed implant and Implant retained distal extension removable partial denture
- Sinus lift and long implant to support fixed screw-retained prosthesis
详细描述
Patient selection:
For this study, 40 patients were selected from the clinic of Prosthodontics Department, Faculty of Dentistry, Mansoura University.
Inclusion criteria:
The patients will be selected according to the following:
- They have atrophied unilateral distal extension maxillary ridge and remaining alveolar bone height 6- 8 mm as verified by preoperative cone beam. They are healthy, free from any systemic diseases relating to the bone resorption (diabetes - hyperparathyroidism). This can be achieved through medical history and clinical examination by a physician and laboratory investigations.
- Posterior maxillary alveolar ridge deficient in height, width and covered with healthy firm covering.
- Patients are less satisfied with conventional removable partial denture.
- Absence of maxillary sinus diseases. Exclusion criteria
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
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The patients will be selected according to the following:
- •They have atrophied unilateral distal extension maxillary ridge and remaining alveolar bone height 6- 8mm as verified by preoperative CBCT, They are healthy, free from any systemic diseases relating to the bone resorption (diabetes - hyperparathyroidism). This can be achieved through medical history and clinical examination by a physician and laboratory investigations.
- •Posterior maxillary alveolar ridge deficient in height, width and covered with healthy firm mucosa.
- •Patients are less satisfied with conventional RPD.
- •Absence of maxillary sinus diseases.
排除标准
- •• Acute or chronic sinus pathology
- •History of a sinus augmentation in the past in the relevant sinus
- •Poor dental hygiene. Smoker.
- •Compromised general health (uncontrolled diabetes, bleeding disorder
结局指标
主要结局
Probing depth evaluation
时间窗: one year
measuring per-implant probing depth in mm. Using a calibrated plastic periodontal probe, the distance between marginal border of the and the tip of the probe was measured in mm and considered as pocket depth.
Implant stability evaluation
时间窗: one year
measuring the mobility of the implants using resonance frequency analysis Implant stability quotient) The resonance frequencies will be measured with the osstell® device (implant stability meter) and will be expressed with measurement scale (implant stability quotient).
Radio graphic evaluation
时间窗: one year
measuring bone loss around implants in mm Radio-graphs were taken using direct digital imaging system - Marginal alveolar bone changes (vertical and horizontal bone loss) were measured at medial and distal surface of each implant in mm.
Plaque index evaluation
时间窗: one year
measuring plaque accumulation around implants using scores Plaque will be assessed according to modified plaque index describe as follows: score 0; no plaque detected, score 1; plaque recognized only by running a probe across a smooth marginal surface of the implant, score 2; plaque can be seen by naked eye, and score 3; abundance of soft mater.
Gingival index evaluation
时间窗: one year
measuring inflammation around implants using scores Modified index will be recorded as follows: score 0; normal , score 1; mild inflammation (slight change in color \& slight edema), but no bleeding on probing, score 2; moderate inflammation (redness \& edema), and bleeding on probing, and score 3; sever inflammation (marked redness, edema \& ulceration) with tendency to spontaneous bleeding.
Patient satisfaction
时间窗: one year
Patient satisfaction using questionnaire (visual analogue scale) Patient satisfaction was evaluated using a questionnaire based on visual analog scale . Patients were asked to mark their answer (amount of satisfaction) on a 100-mm line (with zero refers to not satisfied at all and 100 refers to completely satisfied). The mean of the answers (length of the lines from zero to the marks in mm) for each question. complete satisfaction). The questions cover several items related to prosthesis such as: retention, stability, comfort, ease of cleaning, ease of speaking, ease of chewing, limited activities due to embarrassment, quality of bolus and was subjected to statistical analysis
次要结局
- Muscle activity(one year)
- maximum bite force(one year)
- Prosthetic complication(one year)
研究者
Mohamed Elgamal
Associate professor of removable prosthodontics
Mansoura University