Clinical and Radiological Comparison of Peri Implant Soft Tissue Parameters and Crestal Bone Loss Around Microsurgically and Macrosurgically Placed Implants: A Randomised Controlled Clinical Trail
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- peri-implant papilla height
研究概览
简要总结
This study compares the peri-implant soft tissue and crestal bone loss around single implants when placed macrosurgically and microsurgically.
详细描述
Black triangles in dentition especially in the anterior teeth would pose an esthetic concern. Interdental papilla height is crucial for eliminating this black triangle.
32 participants, 16 in two groups were assigned randomly. Microsurgical approach using microsurgical instruments and magnifying loupes were used for one group participants and similar procedure without magnifying loupes and microsurgical instruments was done in the other group.
comparsion of the microsurgical outcome is done by measuring peri implant papilla gain and radiographic crestal bone loss will be done between the groups.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients desiring implant placement for replacement of missing tooth and willing to participate in the study
- •Non smokers
- •Patients who do not report any relevant medically comprimising conditions or had not received any radiation therapy in head and neck region for cancer therapy.
- •Subjects with satisfactory residual ridges who demonstrated adequate bucco-lingual and mesio-distal space for implant placement, that facilitates primary stability.
- •Patients who demonstrate Plaque Index <10% and good compliance.
- •Full mouth bleeding scores ≤25% before the implant placement.
- •Sites with sufficient band of keratinised mucosa.
排除标准
- •• Pregnant and lactating females
- •Patients on anticancer therapy and immunosuppressant drugs.
- •Implants to be placed in sites with previous periodontal disease
- •Bleeding disorder or on anticoagulant therapy
- •Systemic diseases that would negatively influence wound healing
结局指标
主要结局
peri-implant papilla height
时间窗: 1 year
mesial and distal peri implant papilla height is measured in millimeter
jemt papilla index
时间窗: 1 year
papillary height gained around implant is scored using jemt papilla index 0 = no papilla and no indication of a curvature of the soft tissue adjacent to the implant crown are present; 1. = less than one-half of the papilla height is present, and a convex curvature of the soft tissue adjacent to the implant crown and adjacent tooth can be observed; 2. = at least one-half of the papilla height is present but not to the contact point between the teeth, the papilla is not completely harmonious with the adjacent papillae between the permanent teeth, and soft tissue is harmonious with adjacent teeth; 3. = the papilla fills the entire proximal space and is harmonious with the adjacent papillae, and soft-tissue contour is optimal; 4. = the papillae are hyperplastic and cover too much of the implant or the adjacent tooth, and the soft-tissue contour is irregular
marginal gingiva
时间窗: 1 year
buccal marginal gingival height is measured
pink esthetic score
时间窗: 1 year
scoring assigned to 7 soft tissue criteria by an examiner as 0,1,2,3 and the average of the total score is considered the final score. a maximum score of 14 can be alloted
crestal bone loss
时间窗: 1 year
radiographic crestal bone level around the implants measured from 1st thread of the implant to the coronal or apical most bone level in millimeters.
次要结局
- plaque index(1 year)
- gingival index(1 year)
- surgical time taken(1 day)
- visual analogue scale score(1 year)
- probing depth(1 year)