Clinical And Radiographic Evaluation Of Fucoidan Gel Around Immediate Implants - A Randomized Control Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- wound healing index after immediate implant placement
研究概览
简要总结
The current study is a prospective randomised parallel mouth study to evaluate the effect of Fucoidan gel around immediate implant to assess the wound healing and bone regeneration in comparison to regular implant placement without any gel.
详细描述
Twenty healthy individuals satisfying the inclusion and exclusion criteria were recruited for the study. A detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. All patients were informed about the nature of the study, procedure involved, potential benefits and risks associated with procedure and written informed consent were obtained from all patients. All the patients underwent scaling and root planning.
Following randomization, the site will be assigned to one of the two study groups.
- test group(immediate implant+ fucoidan gel)
- control group (only immediate implant without any gel)
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
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients at least above 18 years of age.
- •Patients presenting with Stage I/II and Grade B periodontitis.
- •Class I extraction socket defects according to modified Elian et al
- •The recipient sites of the implant will be free from pathological conditions.
- •Patients who will comply with oral health care instructions and necessary visits
- •Cases undergoing extraction for dental caries or endodontic conditions.
排除标准
- •Uncontrolled diabetes and severe cardiovascular or infectious diseases
- •Patients with Intravenous and oral bisphosphonate therapy.
- •Patients who are unwilling to return for the follow-up examination.
- •Smokers, lactating and pregnant women.
- •Patients who are psychologically unable to participate.
- •Patients with poor oral hygiene.
结局指标
主要结局
wound healing index after immediate implant placement
时间窗: 7th day,14th day, 21st day, 1month, 3months and 6 months
Landry, Turnbull and Howley wound healing index
次要结局
- Probing depth (PD)(1month,3month and 6 month)
- crestal bone level(baseline, 3month and 6 month)
- gingival tissue thickness(baseline , 3months and 6 months)
- keratinised tissue width(baseline,3months and 6 months)
- CBCT : linear measurement(baseline and 6months)
- Plaque Index(3months)
- Gingival Index(3months)
- Modified sulcular bleeding index(3 months)
研究者
Dr Prabhuji MLV
HEAD OF DEPARTMENT PERIODONTOLOGY
Krishnadevaraya College of Dental Sciences & Hospital