The Effect of Preoperative Antibiotics on Peri-implant Crestal Bone Remodelling and Postoperative Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- peri-implant crestal bone change
研究概览
简要总结
Introduction: In order to minimize postoperative morbidity and failures of dental implant therapy, several antibiotic regimens have been proposed in the literature. However, the extensive use of antibiotics in health care has been debated due to the adverse effects and bacterial resistance. Furthermore, the impact of preoperative antibiotics on peri-implant bone level is still not clear.
Objectives: The primary objective of this study will be to assess whether giving preoperative antibiotics (azithromycin 500mg) after implant placement over 7 days will influence peri-implant crestal bone levels after 4 months in healthy patients undergoing platform-switched implant placement. The secondary objectives will be to evaluate postoperative pain severity, surgery-associated morbidities, and 1-year implant survival rate.
Methods: Fifty individuals will be recruited in a double-masked 2-arm randomized clinical trial. Participants in the intervention group will receive 500mg of azithromycin 1 hour before implant placement. Participants in the control group will take one placebo 1 hour preoperatively. The changes in mesial and distal crestal bone level (primary outcome) will be measured at baseline and 4-month follow-up using standardized periapical radiographs. Pain severity and surgery-associated morbidities (secondary outcomes) will be evaluated by clinical examinations and self-administered questionnaires. Implant survival rate will be assessed at the 1-year follow-up. Descriptive and bivariate analyses will be used to analyze the data. A P value ≤ 0.05 will be considered statistically significant.
Clinical relevance: This study will be the first placebo-controlled double-blinded randomized clinical trial studying the effect of preoperative azithromycin on radiographical, clinical and patient-based outcomes after implant surgery. This type of design will reduce as much as possible the risk of bias and increasing the quality of evidence. The results from this study might help provide guidelines for clinicians that will optimize implant survival rate while decreasing antibiotics exposure to patients undergoing straightforward implant surgery.
详细描述
Background
There have been many antibiotic regimens used to minimize the risks of infections and consequently, increasing the survival rate of dental implants. Initially, it was recommended to give antibiotics at least 1 hour before implant placement followed by daily doses for 10 days. A survey of private dental practices in UK found that there was a wide variation of antibiotic regimens: prophylactic, postoperative, and combination of both pre-and postoperative antibiotics. A recent survey showed that there is no consensus among oral and maxillofacial surgeons in the U.S. Consequently, in order to prevent the overuse of antibiotics and the potential emergence of drug-resistant bacteria, it would be advisable to find an optimal protocol including an antibiotic therapy with a minimal duration while the implant survival rate would remain unchanged. A recent systemic review reported that a single preoperative dose compared to no antibiotic or placebo decreased significantly implant failure. However, the included trials presented high and unclear risk of bias.Therefore, there is a need to carry out well controlled clinical trials that are placebo-controlled and include patient-based outcomes in order to increase the quality of evidence supporting the use of preoperative antibiotics to increase dental implant success.
More specifically, it was recommended by the latest Cochrane review that 2 g of amoxicillin, a commonly used penicillin antibiotic in dentistry, be prescribed before dental implant placement to prevent implant failure. However, allergies to penicillin and its derivatives have been reported by 8% of the U.S. population. Another limitation of penicillin antibiotics is their short half-life, which is about one hour. On the other hand, azithromycin has shown promising results as an adjunct to periodontal therapy and exhibits low toxicity, few side effects, excellent tissue penetration and a long half-life of about 68 hours. It has also anti-inflammatory properties. These characteristics make this antibiotic an interesting alternative to amoxicillin for allergic patients and could potentially demonstrate higher efficacy at preventing peri-implant bone remodeling after implant placement and decreasing postoperative complications.
Therefore, the primary objective of this study is to determine whether giving preoperative antibiotics to healthy patients undergoing straightforward platform-switched implant placement will significantly influence crestal bone loss around dental implants. The test group will receive one dosage of azithromycin before implant placement. The control group will receive an identical placebo preoperatively. Questionnaires for pain and interference with daily activities assessment will be distributed to participants and will be filled for the first postoperative week. Signs of postoperative morbidity will be recorded at 1 week following the surgery and both clinical and radiographic data will be collected at 4 months postoperative to assess the implants status. A radiographic and clinical follow-up will be done 1 year after the surgery.
Objectives and research hypothesis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, 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
- •Periodontally healthy remaining dentition or presenting with mild gingivitis with adequate oral hygiene.
- •Presence of a partially edentulous alveolar ridge that is planned to be restored with no more than 2 implants.
- •To have 1 or 2 implants restored with a crown or fixed bridge.
- •Presence of a non-infected site.
- •Presence of enough bone and soft tissue for the implant to be placed without additional bone augmentation in a 1-stage approach (with healing abutment).
- •Implants 6 mm long or longer.
- •Subjects able and willing to provide written informed consent and comply with study procedures.
排除标准
- •Subjects taking regular analgesics or antidepressants.
- •Smoking 10 cigarettes/cigars or more per day.
- •Marijuana smokers.
- •Use of vaping devices or e-cigarettes
- •Drug abuse.
- •Completely edentulous individuals.
- •Pregnant and nursing women.
- •Allergies to macrolides, and/or non-steroidal anti-inflammatory analgesics.
- •Active peptic ulcers or susceptibility to peptic ulcers.
- •Any systemic or local immunodeficiency.
- •Any blood coagulation impairment or taking anticoagulants (ex.: Coumadin).
- •Presence of uncontrolled periodontitis or poor oral hygiene.
- •Presence of any acute oral infection.
- •Presence of uncontrolled diabetes or other systemic diseases.
- •Previous radiation therapy in the head and neck area.
- •Intravenous bisphosphonates.
- •Oral bisphosphonates intake for more than 4 years.
- •Long-term intake of corticosteroids.
- •Need for routine prophylactic antibiotics prior dental surgery.
- •No intake of antibiotics 3 months prior surgery.
研究组 & 干预措施
Test
- 500mg of azithromycin one hour before implant placement
干预措施: Azithromycin (Drug)
control
- identical placebo one hour before implant placement
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
peri-implant crestal bone change
时间窗: 4 months, 1 year
variations in mm of the alveolar bone around each implant
次要结局
- postoperative morbidities A(1 week, 4 months, 1 year)
- postoperative morbidities B(1 week, 4 months, 1 year)
- postoperative morbidities F(4 months, 1 year)
- postoperative morbidities G(4 months, 1 year)
- postoperative morbidities E(4 months, 1 year)
- pain severity(preop and daily for 1 week)
- suppuration(4 months, 1 year)
- interferences with daily activities(daily for 1 week)
- postoperative morbidities H(4 months, 1 year)
- postoperative morbidities I(4 months, 1 year)
- postoperative morbidities J(4 months, 1 year)
- postoperative morbidities C(1 week, 4 months, 1 year)
- postoperative morbidities D(1 week, 4 months, 1 year)
- survival rate(4 months, 1 year)
- probing depth(4 months, 1 year)
- modified plaque index(1 week, 4 months, 1 year)
- bleeding index(4 months, 1 year)
- anxiety(preop and 1 week)
- postoperative analgesics taken(daily for 1 week)
- duration of surgery (minutes)(immediately postoperatively)
- surgical parameter(immediately postoperatively)
- insertion torque (Ncm)(immediately postoperatively)
研究者
Robert Durand
Associate Professor
Université de Montréal