Evaluation of Effects of Subgingival Administration of Metronidazole Hydrogel 25% in Stage II and III Periodontitis: Randomized, Split Mouth, Single-blind Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Concentration of TNF alfa
研究概览
简要总结
A randomized clinical trial will be performed single-blind to evaluate the effectiveness of sublingual metronidazole hydrogel 25 % in periodontitis.
详细描述
A randomized clinical trial will be performed single-blind to evaluate the effectiveness of sublingual metronidazole hydrogel 25 % in periodontitis in stage II and III.
At least 40 volunteers between the age of 18 and 80, will be enlisted, with the need to perform the SRP. In half of the mouth will be used the metronidazole hydrogel 25%, while in the other half no drugs will be used of delivered.
The study will be carried out in accordance with the Helsinki Declaration and the Protocol will be submitted to the Internal Review Board of the University to obtain authorization. Afterwards, the protocol will be recorded on the databa-se clinicaltrials.gov for clinical trials.
The protocol respects the SPIRIT parameters for the compilation of protocols on clinical trials and the study will respect the parameters of CONSORT sta-tement on randomized clinical trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •10% of sites with survey depth 5 mm
- •Comparable pockets in 4 mouth quadrants
- •Health at systemic level
排除标准
- •Changes in oral mucosa
- •Depth at the poll 5 mm
- •Presence of removable prostheses or orthodontic equipment
- •Allergies to even a single component of a product in testing• Antibiotic-based treatments during the 6 months preceding the start of testing
- •History of previous periodontal treatments in the 12 months preceding the start of the study
研究组 & 干预措施
hydrogel metronidazole 25%
metronidazole hydrogel in adjunct to non surgical periodontal therapy
干预措施: metronidazole hydrogel (Drug)
scaling and root planing
the only use of scaling and root planing
干预措施: scaling and root planning (Procedure)
结局指标
主要结局
Concentration of TNF alfa
时间窗: baseline - 1 week
tumor necrosis factor alfa (pg/ml)
Concentration of IL8
时间窗: baseline - 1 week
interleukin (pg/ml)
Concentration of MMP8
时间窗: baseline - 1 week
matrix metalloproteinases (ng/ml)
Concentration of MMP9
时间窗: baseline - 1 week
matrix metalloproteinases (ng/ml)
Concentration of IL1
时间窗: baseline - 1 week
interleukin (pg/ml)
Concentration of IL6
时间窗: baseline - 1 week
interleukin (pg/ml)
Concentration of IL17
时间窗: baseline - 1 week
interleukin (pg/ml)
Concentration of RANK-L
时间窗: baseline - 1 week
Receptor activator of nuclear factor kappa-Β ligand (pg/ml)
Concentration of OPG
时间窗: baseline - 1 week
osteoprotegerin (pg/ml)
次要结局
- CAL(baseline - 1 week)
- PPD(baseline - 1 week)
- GI(baseline - 1 week)
- FMPS(baseline - 1 week)
- FMBS(baseline - 1 week)
研究者
Enrico Marchetti
Prof. Enrico Marchetti
University of L'Aquila