“A Comparative Evaluation of Implant Stability and Crestal bone levels in Immediately Loaded Implants Placed in grafted versus non-grafted bone.â€- An in-vivo study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- IMPLANTS STABILITY AND CRESTAL BONE LEVELS SIMILAR FOR BOTH GRAFTED AND NON-GRAFTED SITES
研究概览
简要总结
The study was conducted in Department of Prosthodontics, Crown and Bridge and Oral Implantology, SGT University, Gurugram. It was carried out on local patients who had grossly decayed teeth with poor prognosis, one in each quadrant in mandible. The replacement of the tooth was done with endosseous dental implants. The main aim of the study was to evaluate and compare crestal bone levels and implant stability in immediately loaded dental implants in grafted and non-grafted site.
A total of 20 implants were placed in 10 patients. All the patients underwent extraction and implant placement under local anaesthesia. Post extraction, in one of the two quadrants collagen plug is used as the graft material (Test group), and the opposite site is left for spontaneous healing (Control group). After the time interval of 3 months, implants are placed in both the sites i.e grafted and non-grafted. At the time of implant placement, the implants are immediately loaded for both test and control groups. Crestal bone levels were evaluated by means of standardized RVG’s at the time of implant placement, and at time intervals of 1month,3 month,6 months respectively for both groups. Implant stability was measured to assess the level of osseointegration. OstellTMwas used to measure the stability of implant at the time of implant placement, 1 month, 3 month, 6 month post-operatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients having grossly decayed or grade III mobile mandibular posterior teeth indicated for extraction and willing for tooth replacement, without any acute exudate/pus.
- •Patients having minimum available alveolar bone height of 3-4 mm present apically from the base of the extraction socket at the restorative site.
- •Patients having minimum available inter occlusal space of 8-10 mm at the restorative site.

- •Patients with good oral hygiene.

- •Patients who do not have any known systemic disease.
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排除标准
- •1 .According to ASA Classification Class 4 patients
 Organic heart disease with marked signs of cardiac insufficiency.
 Recent myocardial infarction of less than 6 months duration.
 Unstable angina.
 Patients with advanced degrees of pulmonary, renal or endocrine insufficiency.
 2 .According to ASA Classification Class 3 patients Uncontrolled diabetes with complications to vascular or other organs, i.e., retinopathy, neu- ropathy, etc.

- •Immunocompromised patients.
- •Blood dyscrasias
- •Occlusal anomalies Deep Bite Cross Bite
- •Para-functional Habits •
- •Heavy smokers (more than 10 cigarettes per day).

- •Alcohol abusers.

- •Recent history of any acute illness .
 • • • • • • • Bruxism
- •Radiation therapy in orofacial region
 6
- •Patients having unrealistic expectations and psychological problems.
- •Local Factors : Insufficient inter-arch space Edentulous opposing arch (maxillary arch)
 Intraoral draining sinus in relation to the proposed implant site
 Perforation and/or loss of labial bony plate during extraction
 Radiographically assessed jumping space greater than 2mm circumferentially
 Unfavourable implant axis orientation Patients with TMJ disorders.
结局指标
主要结局
IMPLANTS STABILITY AND CRESTAL BONE LEVELS SIMILAR FOR BOTH GRAFTED AND NON-GRAFTED SITES
时间窗: BASELINE, 1 MONTH, 3 MONTH, 6 MONTHS
次要结局
- IMPLANT STABILITY AND CRESTAL BONE LEVELS IN IMMEDIATELY LOADED IMPLANTS ARE SIGNIFICANT FOR EACH GROUP AND NON-SIGNIGICANT WHEN COMPARED IN GRAFTED AND NON-GRAFTED SITE.(BASELINE, 1 MONTH, 3 MONTH, 6 MONTHS)