Pioneering Immediate loading in tissue and bone level implants- A prospective clinical trial across diverse patient profiles in partially edentulous ridges.
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
- Evaluation of radiological, biological, and prosthetic outcomes of immediate loading in tissue and bone level implants.
研究概览
简要总结
This prospective clinical trial aims to evaluate the clinical efficacy and outcomes of immediate loading in tissue and bone level implants among patients with partially edentulous ridges at Subharti Dental College and Hospital in Meerut. By assessing radiological, biological, and prosthetic parameters, the study seeks to understand implant performance in patients with systemic conditions such as diabetes and hypertension. With a sample size of 20 implants, equally divided between tissue and bone level types, the research hypothesizes that tissue level implants will show better soft tissue integration and lower crestal bone loss compared to bone level implants. The results aim to enhance clinical decision-making and improve patient care in medically compromised populations over a two-year period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •INCLUSION CRITERIA 1)Age : 18-75 years 2)Patient willing for procedure (the study is explained, including the procedure and followup for evaluation) 3)Partially edentulous patients indicated replacement with an implant.
- •Patient presents with controlled diabetes/hypertension 5)Implant site free from infection 6)Adequate mouth opening 7) Sufficient bone volume for placing implants 8)Implants should be placed at healed sites.
排除标准
- •EXCLUSION CRITERIA 1.Insufficient bone quality
- •Inadequate mouth opening
- •Heavy smokers
- •Chronic alcoholic
- •Presence of vital anatomical structures close to the implant site
- •Patient under immunosuppressive therapy or radiotherapy
- •Psychiatric disorders
- •Disorders to the implant site related to a history of radiation therapy to the head and neck, or bone augmentation.
- •9.Recent myocardial infarction or cerebrovascular accident, ongoing chemotherapy treatment, intravenous anti-angiogenic agents use 10.Untreated bleeding issues.
结局指标
主要结局
Evaluation of radiological, biological, and prosthetic outcomes of immediate loading in tissue and bone level implants.
时间窗: 1. width of keratinised gingiva will be assessed at 3rd month interval, 6th month interval and at the end of one year interval. | 2.IOPA with Grid to measure crestal bone loss will be assessed at 3rd month ,6th month , and at the end of one year interval. | 3.Incidence/ Frequency /onset of screw loosening at 3, 6 and 1 year interval
1. Width of keratinised gingiva
时间窗: 1. width of keratinised gingiva will be assessed at 3rd month interval, 6th month interval and at the end of one year interval. | 2.IOPA with Grid to measure crestal bone loss will be assessed at 3rd month ,6th month , and at the end of one year interval. | 3.Incidence/ Frequency /onset of screw loosening at 3, 6 and 1 year interval
2. IOPA with grid and cbct to measure crestal bone loss
时间窗: 1. width of keratinised gingiva will be assessed at 3rd month interval, 6th month interval and at the end of one year interval. | 2.IOPA with Grid to measure crestal bone loss will be assessed at 3rd month ,6th month , and at the end of one year interval. | 3.Incidence/ Frequency /onset of screw loosening at 3, 6 and 1 year interval
3. incidence, frequency, onset of screw loosening
时间窗: 1. width of keratinised gingiva will be assessed at 3rd month interval, 6th month interval and at the end of one year interval. | 2.IOPA with Grid to measure crestal bone loss will be assessed at 3rd month ,6th month , and at the end of one year interval. | 3.Incidence/ Frequency /onset of screw loosening at 3, 6 and 1 year interval
次要结局
- 1.Crestal Bone Loss: Assessing the amount of crestal bone loss around the implants at various follow-up intervals.(2.Width of Keratinized Mucosa: Measuring the width of keratinized mucosa at the implant site, specifically at the mid-buccal aspect of each implant.)
研究者
Dr Anshul Trivedi
Subharti Dental College and Hospital, Swami vivekanand University , Meerut