EUCTR2018-000741-39-FR进行中（未招募）1 期
EFFECT OF AZITHROMYCIN ON THE PROPORTION OF FAILURES OF SEVERE PERIODONTITIS NON-SURGICAL TREATMENTS : A RANDOMIZED, DOUBLE-BLIND VERSUS PLACEBO STUDY - AZITHROPARO
Hôpitaux Universitaires de Strasbourg0 个研究点目标入组 124 人开始时间: 2019年9月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 124
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •- Patient over 35 years of age
- •- Patient with severe chronic periodontitis (loss of attachment = 5mm) generalized (>30% sites) (AAP 1999 classification) and pockets > 5mm on at least 5% of sites
- •- Presence of bleeding on the catheter (= 30%)
- •- Patient with at least 15 teeth including 2 molars (excluding wisdom teeth)
- •- Patient benefiting from a social protection system
- •- Voluntary patient with informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 24
排除标准
- •- Patient with contraindications to treatment with azithromycin or its excipient: absolute contraindications are the history of allergy to macrolides or to one of the excipients used in this study, combination with ergot derivatives, cisapride, colchicine and severe liver failure (azithromycin being essentially eliminated by the bile ducts). Other contraindications are in patients at risk of cardiac arrhythmias (diagnosis of QT prolongation and/or concomitant treatments, electrolyte disorders (hypokalemia, hypomagnesia, cardiac arrhythmias, heart failure), severe renal failure, and some drug combinations (antivitamin K, statins)
- •- Patient with aggressive periodontitis (AAP 1999 classification)
- •- Patient smoking more than 10 cigarettes/day
- •- Patient at risk of type B infection (endocarditis) or requiring antibiotic prophylaxis,
- •- Patient who has received antibiotic treatment in the 6 months preceding the periodontal examination
- •- Patient who has received anti-inflammatory treatment in the month preceding the periodontal examination and/or anti-inflammatory treatment for more than 3 consecutive days in the 3 months preceding the periodontal examination
- •- Patient on or after drug treatment (cyclosporine and other anti-rejection, anti-epileptic, calcium channel blocker drugs) affecting periodontal status
- •- Patient with pathologies affecting the periodontal state and/or the systemic or local inflammatory response, such as diabetes, infectious or non-infectious stomatitis, inflammatory and autoimmune diseases, immunosuppression
- •- Patient with a prolonged oral hygiene disability (physical/psychic inability to brush teeth)
- •- Patient with a dilapidated oral condition (untreated cavities, unrestated teeth), oral infectious foci whose management requires antibiotic treatment within 6 months
- •- Patient who has had specialized periodontal treatment, curettage/surfacing, or periodontal surgery in the year preceding the examination.
- •- Pregnant woman (controlled by a negative urine beta-HCG test at inclusion) or during breastfeeding
- •- Patient with chronic infections that occur repeatedly (more than 3 times per year) and require antibiotics
- •- Patients who received oral antiseptic treatment in the month prior to the examination
- •- Patient with swallowing disorders
- •- Patient included in another intervention research protocol, or in periods of exclusion (participation in observational research is still possible)
- •- Patient under guardianship and safeguard of justice
- •- Patient with a high risk of bleeding and/or INR>4.
- •- Patient unable to cooperate or understand study and care instructions
- •- Patient under guardianship, curatorship or guardianship
研究者
相似试验
尚未招募
4 期
Effect of Azithromycin on preterm babies who are on ventilatorCTRI/2022/12/048582JSS Medical College Hospital
已完成
3 期
Effect of Azithromycine (AZM) on gingival overgrowthgingival enlargement.gingival fibromatosisIRCT2017040529321N2Vice Chancellor for Research, Kerman university of medical sciences24
招募中
3 期
Comparison of the Effectiveness of Azithromycin and Erythromycin on the rate of clinical chorioamnionitis and Latency period up to termination of pregnancy in women with Preterm Premature Rupture of Membrane pregnancyIRCT20240513061769N1Zanjan University of Medical Sciences120
招募中
2 期
The effect of azithromycin on the prevention of asthma attacksChronic Asthma.Severe persistent asthmaJ45.5IRCT20100102002954N24Shahroud University of Medical Sciences116
尚未招募
2 期
The effect of azythromycin in the control of refractory asthma patientsSevere persistent asthma.Severe persistent asthmaJ45.5IRCT20100102002954N21Shahroud University of Medical Sciences112