Clinical and Microbiological Evaluation of Metronidazole as a Systemic Antimicrobial Adjunct to Periodontal Surgery in the Treatment of Patients With Periodontitis Positive to Porphyromonas Gingivalis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 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 the use of a systemic antimicrobial (metronidazole) as an adjunct to periodontal surgery provides additional clinical and microbiological beneficial effects compared to periodontal surgery alone plus a placebo, in patients with non treated periodontitis (stage III and IV) positive to Porphyromonas gingivalis.
详细描述
Design: pilot, randomized, parallel, placebo controlled and triple blind clinical trial.
Sample: Patients with generalized severe chronic periodontitis (stages III and IV) and positive to Porphyromonas gingivalis who potentially need periodontal surgery were recruited from those who attended the postgraduate program in periodontics at the Complutense University in Madrid.
Patients were randomly assigned to the test group (periodontal surgery + metronidazole) or control group (periodontal surgery + placebo).
Study visits:
- Examiner calibration
- Recruitment of patients. Screening. Data collection (clinical and microbiological variables)
- Phase I
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 patient allocation.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of generalized severe chronic periodontitis (Armitage 1999) or periodontitis stages III or IV (Papapanou et al., 2018) that may require periodontal surgery.
- •Have at least 10 teeth in function, excluding third molars.
- •Present sites with pocket probing depth (PPD) ≥ 6mm in ≥ 2 teeth in ≥ one quadrant
- •Present radiographic evidence of ≥ 30 % bone loss in ≥ 30% of the dentition
- •Detection of Porphyromonas gingivalis in subgingival samples taken at the screening visit as well as in the post-scaling and root planing visit and processed by culture.
- •Systemically healthy patients.
排除标准
- •Pregnant or lactating women.
- •Systemic pathology and/or taking medication that may affect the periodontal situation and/or patients requiring antibiotic prophylaxis.
- •Have received systemic antimicrobial treatment 6 months prior to the beginning of the study.
- •Have received periodontal treatment 6 months prior to the beginning of the study.
- •Patients allergic to metronidazole.
- •Patients allergic to cornstarch.
- •Patients who refuse to sign the informed consent.
研究组 & 干预措施
Metronidazole + periodontal surgery
Periodontal surgery + Metronidazole (metronidazole 500mg/8h/7days)
干预措施: Metronidazole (Drug)
Metronidazole + periodontal surgery
Periodontal surgery + Metronidazole (metronidazole 500mg/8h/7days)
干预措施: periodontal surgery (Procedure)
Placebo + periodontal surgery
Periodontal surgery + Placebo (cornstarch 500mg/8h/7days)
干预措施: Placebo (Drug)
Placebo + periodontal surgery
Periodontal surgery + Placebo (cornstarch 500mg/8h/7days)
干预措施: periodontal surgery (Procedure)
结局指标
主要结局
Probing Pocket Depth (PPD)
时间窗: 6 weeks after scaling and root planing compared to 12 months after the surgery
Full mouth measurement at 6 sites per tooth with a manual periodontal probe University North Carolina 15 (UNC-15mm)
次要结局
- Gingival Recession (REC)(At baseline (before scaling and root planing), 6 weeks after scaling and root planing (Reevaluation Phase I) and during the maintenance Phase III (3, 6 and 12 months after periodontal surgery))
- Full mouth plaque score (FMPS)(At baseline (before scaling and root planing), 6 weeks after scaling and root planing (Reevaluation Phase I) and during the maintenance Phase III (3, 6 and 12 months after periodontal surgery))
- Percentage of periodontal pathogens(At baseline (before scaling and root planing), 6 weeks after scaling and root planing (Reevaluation Phase I) and during the maintenance Phase III (3, 6 and 12 months after periodontal surgery))
- Probing Pocket Depth (PPD)(At baseline (before scaling and root planing), 6 weeks after scaling and root planing (Reevaluation Phase I) and during the maintenance Phase III (3, 6 and 12 months after periodontal surgery))
- Full mouth bleeding score (FMBS)(At baseline (before scaling and root planing), 6 weeks after scaling and root planing (Reevaluation Phase I) and during the maintenance Phase III (3, 6 and 12 months after periodontal surgery))
- Furcation lesions(At baseline (before scaling and root planing), 6 weeks after scaling and root planing (Reevaluation Phase I) and during the maintenance Phase III (3, 6 and 12 months after periodontal surgery))
- Clinical attachment level (CAL)(At baseline (before scaling and root planing), 6 weeks after scaling and root planing (Reevaluation Phase I) and during the maintenance Phase III (3, 6 and 12 months after periodontal surgery))
- Total Bacterial Counts(At baseline (before scaling and root planing), 6 weeks after scaling and root planing (Reevaluation Phase I) and during the maintenance Phase III (3, 6 and 12 months after periodontal surgery))
- Counts of periodontal pathogens(At baseline (before scaling and root planing), 6 weeks after scaling and root planing (Reevaluation Phase I) and during the maintenance Phase III (3, 6 and 12 months after periodontal surgery))
- Ocurrence of side effects(1 week after the last surgery + pills intake (placebo or metronidazole))
- Adverse Effect Description(1 week after the last surgery + pills intake (placebo or metronidazole))
- Degree of affectation of an adverse effect(1 week after the last surgery + pills intake (placebo or metronidazole))
- Patient Compliance(1 week after the last surgery + pills intake (placebo or metronidazole))
研究者
Prof. Elena Figuero
Principal Investigator
Universidad Complutense de Madrid