Study of the Effects of Intensive Treatment of Periodontitis on Blood Pressure Control and Vascular Function
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Blood Pressure Change
研究概览
简要总结
Hypertensive patients with chronic periodontitis will be randomized to either intensive treatment or supragingival hygienic treatment and the effects on blood pressure will be identified.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Periodontitis with three or more periodontal pockets with a probing depth (PD) > 5mm
- •Bleeding of these periodontal pockets on probing
- •Have at least 20 natural teeth
- •Provide informed consent and willingness to cooperate with the study protocol
- •Age >25 years old
- •Absence of other significant oral infections.
- •Primary Hypertension on stable treatment
排除标准
- •Clinical symptoms of acute inflammatory disorders incl flu, rhinitis, sinusitis etc. within past 3 weeks
- •Hospitalization for any reason within the past 3 months; Life expectancy of < 3 years;
- •Allergic disorders; History of chronic infectious disease, Chronic Obstructive Pulmonary Disease (COPD), tuberculosis; chronic hepatitis B or C infection; interstitial pneumonitis, bronchiectasis; known chronic pericardial effusion, pleural effusion, or ascites; liver disease;
- •Other known chronic inflammatory or autoimmune condition such as lupus or rheumatoid arthritis, ulcerative colitis or Crohn's disease
- •Secondary hypertension (known plasma renin screening, abdominal ultrasound with doppler and other investigations)
- •Non-basal cell malignancy or treated myelo or lymphoproliferative disease within the past 5 years;
- •Known HIV positive; Immunizations within past 3 months
- •Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
- •Primary pulmonary hypertension.
- •Use of systemic or local steroids or immunosuppressive agents within 6 months of the inclusion.
- •Individual is pregnant or nursing
- •History of alcohol abuse or unwillingness to limit alcohol consumption to less than 4 drinks per week
研究组 & 干预措施
Hygenization Treatment
Basic oral hygiene instructions Supragingival plaque removal
干预措施: Dental Hygienization Treatment (Procedure)
Intensive Treatment
One-Stage Full-Mouth Disinfection. Scaling and root planing, four quadrants in one session. Extraction of radix relicta. Subgingival chlorhexidine (PerioKIN) (0.2%) in all pockets. Oral hygiene instructions.
干预措施: Intensive Treatment (Procedure)
Intensive Treatment
One-Stage Full-Mouth Disinfection. Scaling and root planing, four quadrants in one session. Extraction of radix relicta. Subgingival chlorhexidine (PerioKIN) (0.2%) in all pockets. Oral hygiene instructions.
干预措施: Chlorhexidine (Intensive Treatment) (Drug)
结局指标
主要结局
Blood Pressure Change
时间窗: 3 months
Ambulatory Blood Pressure Monitoring
次要结局
- Flow Mediated Dilatation(3 months)
研究者
Tomasz Guzik
Prof. dr hab. med.
Jagiellonian University