Clinical and Microbiological Comparison of Two Different Systemic Antimicrobials (Azithromycin Versus Metronidazole) as Adjuncts to Periodontal Surgery in the Treatment of P.Gingivalis Periodontitis Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Probing pocket depth (PPD)
研究概览
简要总结
The objective of this study is to determine whether, in patients with non treated periodontitis (stage III and IV) positive to Porphyromonas gingivalis, the use of systemic antimicrobials (metronidazole versus azithromycin) as an adjunctive treatment to periodontal surgery provides clinical and microbiological benefits.
详细描述
Design: randomized, parallel and triple blind clinical trial
Sample: Patients with periodontitis (stages III and IV) and positive to Porphyromonas gingivalis who potentially need periodontal surgery were recruited. 25 patients were randomized to the test group (periodontal surgery + azithromycin) and another 25 subjects to the control group (periodontal surgery + metronidazole).
Study visits:
-
Examiner calibration
-
Recruitment of patients. Screening. Data collection (clinical and microbiological variables).
-
Phase I.
-
Non-surgical periodontal treatment (2 visits).
-
Reevaluation at 6 weeks. Data collection (clinical and microbiological variables). Identification of study candidate patients (Patients with probing pocket depth > 5 mm and positive to Porphyromonas gingivalis). Randomization of study groups.
-
Phase II. Surgical periodontal treatment.
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, Investigator, Outcomes Assessor)
盲法说明
The subjects were randomly assigned to the treatment groups in ascending order according to a balanced distribution system through a computer generated random number design table (random block design). Randomization was balanced according to the smoking habit at the initial visit to ensure homogeneity in the treatment groups.
The method of allocation concealment selected were opaque envelopes. The research coordinator was responsible for the randomization and allocation of patients.
The 50 opaque envelopes (25 / group) were prepared.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of periodontitis (stages III or IV) that may require periodontal surgery
- •Have at least 10 teeth in function, excluding third molars.
- •Present locations with probing depth (PS)> 6 mm in at least 30% of the teeth.
- •Present radiographic evidence of moderate-severe bone loss in at least 30% of the dentition.
- •Detection of P. gingivalis in subgingival samples taken at the screening visit as well as in the post-scaling and root planning visit and processed by culture.
- •Systemically healthy patients.
排除标准
- •Pregnant or lactating women.
- •Presenting systemic pathology and / or taking medication that may affect the periodontal situation and / or patients requiring antibiotic prophylaxis.
- •Have received systemic antimicrobial treatment in the previous 6 months.
- •Have received periodontal treatment in the 6 months prior to the beginning of the study.
- •Patients allergic to metronidazole, or to any of the components of commercial formulations thereof (Flagyl®).
- •Patients allergic to azithromycin, or to any of the components of commercial formulations thereof (Zithromax®).
- •Patients who refuse to sign the informed consent.
研究组 & 干预措施
azythromycin + periodontal surgery.
Periodontal surgery + Azithromycin (500 mg every 24 h for 3 days).
干预措施: Azithromycin (Other)
metronidazole + periodontal surgery
Periodontal surgery + Metronidazole (500 mg every 8 h for 7 days).
干预措施: Metronidazole (Other)
结局指标
主要结局
Probing pocket depth (PPD)
时间窗: At 6 weeks after periodontal surgery
Full mouth measurement at 6 sites per tooth, with a manual periodontal probe University North Carolina 15 (UNC-15 mm)
次要结局
- Gingival Recession (REC)(At the beginning of the study, 6 weeks after scaling and root planning (Reevaluation phase I), 6 weeks after the last surgery session (Reevaluation Phase II) and during the maintenance Phase III (3, 6, 9, 12 and 48 months after periodontal surgery))
- Furcations(At the beginning of the study, 6 weeks after scaling and root planning (Reevaluation phase I), 6 weeks after the last surgery session (Reevaluation Phase II) and during the maintenance Phase III (3, 6, 9, 12 and 48 months after periodontal surgery))
- Percentage of periodontal pathogens(At the beginning of the study, 6 weeks after scaling and root planning (Reevaluation phase I) and during the maintenance Phase III (3, 6, 12 and 48 months after periodontal surgery))
- Probing pocket depth (PPD)(At the beginning of the study, 6 weeks after scaling and root planning (Reevaluation phase I), 6 weeks after the last surgery session (Reevaluation Phase II) and during the maintenance Phase III (3, 6, 9, 12 and 48 months after periodontal surgery))
- Gingival index (GI)(At the beginning of the study, 6 weeks after scaling and root planning (Reevaluation phase I), 6 weeks after the last surgery session (Reevaluation Phase II) and during the maintenance Phase III (3, 6, 9, 12 and 48 months after periodontal surgery))
- Total bacterial counts(At the beginning of the study, 6 weeks after scaling and root planning (Reevaluation phase I) and during the maintenance Phase III (3, 6, 12 and 48 months after periodontal surgery))
- Plaque index (PlI)(At the beginning of the study, 6 weeks after scaling and root planning (Reevaluation phase I), 6 weeks after the last surgery session (Reevaluation Phase II) and during the maintenance Phase III (3, 6, 9, 12 and 48 months after periodontal surgery))
- Clinical attachment level (CAL)(At the beginning of the study, 6 weeks after scaling and root planning (Reevaluation phase I), 6 weeks after the last surgery session (Reevaluation Phase II) and during the maintenance Phase III (3, 6, 9, 12 and 48 months after periodontal surgery))
- Counts of periodontal pathogens(At the beginning of the study, 6 weeks after scaling and root planning (Reevaluation phase I) and during the maintenance Phase III (3, 6, 12 and 48 months after periodontal surgery))
- Appearance of side effects after taking antibiotic(1 week after antibiotic consumption)
- Type of adverse effect after taking antibiotic(1 week after antibiotic consumption)
- Degree of affectation(1 week after antibiotic consumption)