Clinical and Microbiological Efficacy of a Azithromycin as an Adjunct to Non-Surgical Periodontal Treatment : A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Difference between groups (placebo v/s azithromycin) in the mean (±SD) and changes or delta (∆) in number of sites with PPD 1-3 mm, 4-6 mm and ≥ 7 mm in stage III grade B periodontitis patients, before and 1, 3 and 6 months after NSPT.
研究概览
简要总结
This study evaluates the effect of the systemic administration of azithromycin as a therapy associated with non-surgical periodontal treatment, in the clinical and microbiological variables of patients with Severe Periodontitis with moderate rate of progression (Stage III grade B). A double-blind, randomized, controlled trial was conducted with 18 voluntary patients with a history of moderate to severe chronic periodontitis, who met the inclusion and exclusion criteria and signed an informed consent.
The intervention group received non-surgical periodontal therapy (NSPT) plus azithromycin, and the control group received NSPT plus placebo. Probing Pocket Depth (PPD) Clinical Attachment Level (CAL),O'Leary index (OI) and Bleeding on Probing (BoP) were evaluated as clinical variables while Porphyromonas gingivalis (Pg), Tannerella forsythia (Tf), Treponema denticola (Td), Fusobacterium nucleatum (Fn) were the microbiological variables detected by conventional Polymerase chain reaction (PCR).
详细描述
Definition of the sample: Patients over 18 years old admitted to the Diagnostic Unit of the Faculty of Dentistry (DUFD), Viña del Mar campus of the Universidad Nacional Andres Bello (UNAB) during 2016, with a diagnosis of severe periodontitis, meeting both the inclusion and exclusion criteria and voluntarily agree to participate of the present research work, signing an informed consent. The chosen participants were informed of the nature of the research, potential risks and compensation for participating in the study, obtaining informed consent from every patient.
Sample Size Calculation: To calculate the minimum sample size necessary for the constitution of the control and intervention groups, the variance of the probing depth difference were considered as fixed values, which were based on the results described above.Considering the above and using a level of significance of 5%, a statistical power of 80% and an estimation error of 1 mm, at least 7 patients were obtained for each group, giving a total of 14 minimum subjects to study.
Protocol and clinical exam: Out of a total of 32 patients who were selected, 20 of those who met the inclusion criteria were randomly assigned by the study coordinator to one of the two groups using a random generation sequence employing a software. Two subjects declined to participate in the research, so the study had 9 participants in each group. In this way, two groups were formed to investigate: an intervention group that received NSPT plus 500 mg of azithromycin once a day for three days immediately after the NSPT, and a control group that received NSPT plus placebo under the same conditions as the intervention group.
Randomization: Only the main investigator, who made the randomization by using the Epidat 4.0 program, had knowledge about the content of the containers and the group to which each patient belonged in the study, therefore, was in charge of labeling the containers, achieving in this way that collaborators and participants in the investigation did not know their content until after the study was finished.
Standardization and calibration: The data was collected using instruments and supplies with the same commercial brands, in a single chair, under the same lighting and by a single examiner in the case of clinical data and another examiner for microbiological variables.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Periodontal treatment, lactose tab
Periodontal treatment (scaling and root planning) and one tablet containing lactose once a day for three days immediately after the scaling and root planning.
干预措施: Lactose tab (Other)
Periodontal treatment, Antibiotic
Periodontal treatment (scaling and root planning) and one tablet containing 500 milligrams (mg) of Azithromycin once a day for three days immediately after the scaling and root planning.
干预措施: Azithromycin (Drug)
结局指标
主要结局
Difference between groups (placebo v/s azithromycin) in the mean (±SD) and changes or delta (∆) in number of sites with PPD 1-3 mm, 4-6 mm and ≥ 7 mm in stage III grade B periodontitis patients, before and 1, 3 and 6 months after NSPT.
时间窗: Baseline,1, 3 and 6 month
Before, 1, 3 and 6 month after performing NSPT with placebo or azithromycin, PPD was measured in all the patients in the study and corresponds to the distance in millimeters from the gingival margin (MG) to the inserted probe´s tip of the most apical portion of the periodontal pocket. It was obtained by measuring with a North Carolina periodontal probe (Hu-Friedy® Manufacturing Inc., Chicago, IL, USA), from the bottom of the pocket to the MG, in a position parallel to the vertical axis of the tooth, with a pressure no greater than 0.25 Newton (N). PD was performed in a circular direction over the entire surface of each tooth, registering the 6 deepest sites per tooth (mesiobuccal, buccal, distobuccal, distolingual, lingual and mesiolingual). Subsequently, those sites with PPD 1-3 mm, 4-6 mm and ≥ 7 mm were counted and the significance of differences between groups at each time point was assessed using the unpaired t-test (p\>0.05) or Mann-Whitney U test.
次要结局
- Difference between groups for the bleeding on probing (BoP) Index, in stage III grade B periodontitis patients before and 1, 3 and 6 month after performing NSPT with placebo or azithromycin.(Baseline,1, 3 and 6 month)
- Presence of periodontopathogens before, 3 and 6 month after performing NSPT with placebo or azithromycin.(Baseline, 3 and 6 month)
- Risk for disease progression, according to Lang & Tonetti (2003).(Baseline and 6 month)
- Clinical Attachment Level (CAL) gain in the sixth month after NSPT with placebo or azithromycin.(Baseline and 6 month)
- Difference between groups for the O'Leary index (OI),in stage III grade B periodontitis patients before and 1, 3 and 6 month after performing NSPT with placebo or azithromycin.(Baseline,1, 3 and 6 month)
研究者
Mariely Navarrete
Associate Professor, Director of Graduate Periodontics Faculty of Dentistry Andres Bello University, Viña del Mar campus
Universidad Nacional Andres Bello