CTRI/2025/09/094492尚未招募不适用
A comparative study of customized versus standard abutments on esthetic outcome in the maxillary anterior region
Aashita Boricha1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2025年10月3日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- 1.Compare crestal bone level of customized with standard abutment.
研究概览
简要总结
After medical/dental history, examination, radiographs, and informed consent, patients will receive prophylactic antibiotics (Amoxicillin 2 g 1 hr prior). Implants will be placed under local anaesthesia (2% Lignocaine with adrenaline) following standard surgical protocols.
At 4 months, second-stage surgery will be performed and gingival formers placed.
- Customized abutment group: After 2 weeks digital scanning will be done customized abutments and crowns fabricated and delivered.
- Standard abutment group: After 2 weeks conventional impressions will be made standard abutments and crowns fabricated and delivered.
Outcomes will be evaluated by
- Probing depth around abutments,
- Crestal bone loss (radiographically at baseline, 1, 3, 6, 12 months),
- Esthetic outcome using Pink and White Esthetic Score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Patient with partial edentulous space in the anterior maxilla.
- •2 Patient between the age group of 18-65 years.
- •3 No disease of the oral mucosa, No local inflammation.
- •4 Extraction at least 3-4 months previously.
- •5 Sufficient bone volume at the implant site.
- •6 Patients with good oral hygiene.
排除标准
- •1 Patients with systemic diseases (Such as cardiac, coagulation and leukocyte diseases or metabolic disorders) 2 History of radiotherapy to the head and neck 3 Current treatment with steroids( under systemic bisphosphonates) 4 Neurological or psychiatric disability that could interfere with treatment; 5 Immunocompromised status, including human immunodeficiency virus infected 6 Severe teeth grinding or bruxism; 7 Smoking habit ,drug or alcohol abuse 8 Pregnant / Nursing at the time of enrollment 9 Inadequate compliance.
结局指标
主要结局
1.Compare crestal bone level of customized with standard abutment.
时间窗: at basline,1,3,6,12 months
次要结局
- 1.Evaluate customized and standard abutment association with soft tissue health.(2.Compare pink and white esthetic score between customized and standard abutment.)
研究者
Aashita Boricha
King Georges Medical University Lucknow
研究点 (1)
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