Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Safety Assessment of a No - Antibiotic - Prophylaxis Protocol for Single - Implant Placement in Straightforward Cases: A Pilot Study
This pilot study will examine whether a single dental implant can be placed safely without giving antibiotics before or after surgery in patients with straightforward cases in Vietnam. Adults who are generally healthy, have one missing back tooth, and have enough bone for an implant will have the implant placed with standard infection-control measures (antiseptic mouth rinse, a surgical guide, and ibuprofen for relieving the pain) but no preventive antibiotics. Antibiotics will be given only if an infection develops. Participants will be seen 2 days, 7 days, 14 days, 1 month and 3 months after surgery. The main outcome is early implant failure, meaning the implant is lost before the replacement tooth is fitted. We will also record infection, pain, painkiller use, and gum health around the implant. The study will enroll 39 participants at the dental specialty clinic of the University of Medicine and Pharmacy at Ho Chi Minh City.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Hien Tran Ngoc Dang, Doctor of Odonto-Stomatology
- 电话号码：(+84-28) 3855 8735
- 邮箱：dtnhien.nt25@ump.edu.vn
学习地点
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Ho Chi Minh City、越南
- Odonto-Stomatology Clinic, University of Medicine and Pharmacy at Ho Chi Minh City
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接触：
- Anh TN Nguyen, PhD
- 电话号码：+84-28 3855 9225
- 邮箱：pkckrhm@ump.edu.vn
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age 18 years or older
- ASA physical status I or II
- Single missing posterior tooth with an indication for dental implant placement
- Straightforward case: sufficient bone volume, no bone graft or sinus lift, no complex soft-tissue procedure, bone density D2 or D3 (Misch)
- Periodontal disease treated and stable
- Written informed consent
Exclusion Criteria:
- Immediate implant placement
- Beta-lactam allergy
- Systemic antibiotics within the previous 4 weeks
- Long-term high-dose corticosteroids, immunosuppressants or intravenous bisphosphonates
- Poorly controlled diabetes (HbA1c above 7.5%)
- Indication for mandatory antibiotic prophylaxis (high risk of infective endocarditis)
- Pregnancy or breastfeeding
- Current smoking or alcohol dependence
- Poor oral hygiene or non-cooperation
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Single Implant Placement Without Antibiotic Prophylaxis
Adults with one missing posterior tooth in a straightforward case receive a single dental implant placed with a tooth-supported surgical guide. No systemic antibiotic is given before or after surgery. Standardised care: ibuprofen 400 mg 1 hour before surgery; chlorhexidine 0.12 to 0.2% mouthrinse for 60 seconds; extraoral povidone-iodine 10% antisepsis. After surgery: ibuprofen 400 mg (9 tablets, up to three times daily, stopped when pain resolves) and gentle chlorhexidine 0.12% rinse on day 1. Systemic antibiotics (amoxicillin/clavulanate 1 g twice daily) are used only as rescue treatment if infection is diagnosed. Follow-up at day 2, day 7, day 14, 1 month and 3 months. |
Single dental implant placement with standardised perioperative care (ibuprofen, chlorhexidine mouthrinse, povidone-iodine antisepsis, surgical guide) and no systemic antibiotic prophylaxis. Antibiotics are used only as rescue treatment for diagnosed infection. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Early Implant Failure Rate
大体时间：1 month and 3 months after implant placement
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Proportion of participants whose implant is lost before functional prosthetic loading (implant removed for mobility with infection, progressive bone loss, or no response to treatment), assessed by clinical and radiographic examination. |
1 month and 3 months after implant placement
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Early Postoperative Infection Rate
大体时间：Day 2, day 7, day 14, 1 month and 3 months after implant placement
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Proportion of participants with early postoperative infection, defined as at least two of the following four signs: pus or fistula; fever 38°C or above; pain increasing after postoperative day 3; progressive or spreading swelling beyond the surgical area after day 3. |
Day 2, day 7, day 14, 1 month and 3 months after implant placement
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Postoperative Pain
大体时间：Day 2, day 7 after implant placement
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Pain intensity on a 0 to 10 visual analogue scale (0 = no pain, 10 = worst pain imaginable) |
Day 2, day 7 after implant placement
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Ibuprofen Use After Surgery
大体时间：Day 7 after implant placement
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Total number of ibuprofen 400 mg tablets taken for pain after surgery |
Day 7 after implant placement
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Peri-implant Soft-Tissue Status
大体时间：1 month and 3 months after implant placement
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Modified sulcus bleeding index (mSBI), score 0 to 3 |
1 month and 3 months after implant placement
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合作者和调查者
调查人员
- 首席研究员：Hien Tran Ngoc Dang, Doctor of Odonto-Stomatology、University of Medicine and Pharmacy at Ho Chi Minh City
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 26723 - ĐHYD
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Individual participant data will not be shared because of the small sample size, the risk of re-identification of participants, and because data sharing is not part of the ethics-approved consent.
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