A Randomized, Double-Blind, Split-mouth, Placebo-controlled, Clinical Trial of the Effect of Sub-gingival Irrigation With Ibuprofen Mouthwash in Treatment of Periodontal Diseases
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- Reduction of periodontal pocket
研究概览
简要总结
Aim: Use an ibuprofen mouthwash 2% irrigate subgingival in improving the progression of periodontal diseases can be evaluated. Materials and Methods: 22 patients with chronic periodontitis without any systemic disease who have had periodontal disease, and 2 molars that have periodontal pockets deeper than 4 mm on either side of the lower jaw have the clinical examinations. Interventions: For patients who participated in this study, subjects who received oral hygiene instruction and scaling root planing (SRP), After 2 weeks, They were divided into two groups as determined by randomization in this study, Experimental group: ibuprofen 2% mouthwash (made from the Faculty of Pharmaceutical Sciences, Islamic Azad University, Tehran), Control group: placebo, Subgingival Irrigation of ibuprofen 2% mouthwash with an insulin syringe 0.5 ml were rinsed, Clinical measurements including probing depth (PD), clinical attachment levels (CAL), Plaque Index (PI), and Bleeding Index (BI) were recorded and the patients were recalled per once every 2 weeks for 3 months is repetitive, and at the end of 3 months, were evaluated changes in clinical periodontal parameters. ®
详细描述
Patients and methods
Eligible participants were 22 adult patients treated for chronic periodontitis and participating in a supportive periodontal therapy program at the Department of Periodontology of the Dental Clinic of the Islamic Azad University, Dental Branch of Tehran were included in the current study; Recruitment of participants started November 2013 and ended September 2014. The study met the criteria of the Helsinki Declaration of1975, revised in 2008. The survey plan was reviewed and sanctioned, approved by the ethics commission of the Institutional Ethical Committee and Review Board of the Deputy of Research, School of Dentistry. All subjects received the oral and written explanation of the intent of the survey and signed an informed consent after receiving detailed information about the purpose, the benefits, and the possible risks associated with the trial. Individuals satisfying the following entry criteria were recruited:
- Diagnosed suffering from initial (early) to moderate chronic periodontitis;
- Adult patients, more than 28 years old with at least 20 remaining teeth and at least three teeth in each quadrant;
- The presence of at least two residual sites with a probing pocket depth (PPD≥4 mm in two opposite quadrants, which showed bleeding upon probing, radiographically comparable amount of periodontal breakdown and good matching in tooth type, also clinical and minimal radiographic signs of initial (early) to moderate (clinical attachment level of 1 to 3mm.
Exclusion criteria:
Periodontal treatment (non-surgical) the previous six months Systemic diseases; Hypersensitive to Ibuprofen; Systemic antibiotic or anti-inflammatory drugs within the three months preceding the beginning of the study; Pregnant or nursing females; Smoking; No acute periodontal conditions, such as necrotizing periodontal diseases or periodontal abscesses. Mouth rinses during the entire period of the study orthodontic treatments, Use of removable dentures, Extensive dental restorations.
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, Investigator)
入排标准
- 接受健康志愿者
- 是
入选标准
- •The patients systemically healthy were selected for the study.
- •The subjects had with periodontal pocket depths of more than 4 mm on at least two teeth in the mandibular molar area that observed on probing.
排除标准
- •Existing systemic disease;
- •Hypersensitive to Ibuprofen;
- •The use of any Antibiotic or Anti-inflammatory drugs within the 6 months preceding the beginning of the study;
- •Pregnant or nursing females;
- •Smoking; Orthodontic treatments;
- •Extensive dental restorations;
- •Use removal denture;
- •Mouth rinses;
- •during the entire period of the study.
研究组 & 干预措施
ibuprofen mouthwash
Subgingival Irrigation of ibuprofen 2% mouthwash (made from the Faculty of Pharmaceutical Sciences, Islamic Azad University, Tehran) with an insulin syringe 0.5 ml were rinsed
干预措施: Ibuprofen 2% mouthwash (Drug)
placebo mouthwash
Subgingival Irrigation of placebo 2% mouthwash (made from the Faculty of Pharmaceutical Sciences, Islamic Azad University, Tehran) with an insulin syringe 0.5 ml were rinsed
干预措施: placebo (Drug)
结局指标
主要结局
Reduction of periodontal pocket
时间窗: 15 days
periodontal probe
次要结局
- Reduction of bleeding on probing(3 months)
研究者
Amirhossein Farahmand
assistant prof
Islamic Azad University, Tehran