The Influence of Local Antibiotic Therapy on the Outcomes Following Periodontal Regeneration Procedures.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Assessment of the influence of local antibiotic therapy on the clinical, outcomes following periodontal regeneration procedures.
研究概览
简要总结
Assessmnet of the influence of local antibiotic therapy on the clinical, radiological, microbiological parameters and the inflammation mediators levels in the gingival crevicular fluid (GCF) following periodontal regeneration procedures in patients with periodontitis.
详细描述
Forty generally healthy adults diagnosed with stage III periodontitis were randomly divided into two groups. In the test group, SRP was performed with the subsequent application of local antibiotics (10% doxycycline) into periodontal pockets at the site of the planned surgical intervention, while in the control group SRP was performed alone. Two weeks after, on the day of the surgical treatment, the M-MIST/MIST procedure was performed in both the test and control groups with the use of enamel matrix derivative (EMD). Clinical examination was performed before and 6 and 12 months after treatment. For radiological measurements RVG was performed. For inflammation mediators levels determination in GCF samples ELISA method will be used. For microbiological assessments Real Time PCR method will be used.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •presence of an intrabony defect, with a pocket depth (PD) ≥ 6 mm and a radiological defect depth of ≥3 mm and width of ≥2 mm;
排除标准
- •periodontal treatment within 3 months prior to the study;
- •antibiotic therapy within 3 months prior to the study;
- •smoking; presence of systemic diseases affecting periodontal healing, i.e.: immunosuppressive diseases, diabetes, osteoporosis, AIDS, hypertension treated with calcium channel blockers;
- •use of steroids or other immunosuppressive drugs;
- •pregnant and breastfeeding women
研究组 & 干预措施
SRP+SURG
In the control group (20 subjects) SRP was performed alone. After two weeks regeneration procedure was performed.
干预措施: SRP+SURG (Procedure)
SRP+ANB+SURG
The test group consisted of 20 people participants who underwent the SRP procedure with local antibiotic application into the pocket was performed. After two weeks regeneration procedure was performed.
干预措施: SRP+ANB+SURG (Drug)
结局指标
主要结局
Assessment of the influence of local antibiotic therapy on the clinical, outcomes following periodontal regeneration procedures.
时间窗: up to 12 months after treatment procedure
PD (Pocket Depth) reduction- measured from the gingival margin to the bottom of the sulcus (mm) CAL (Clinical Attachment Level) gain- measured from the cemento-enamel junction to the bottom of the sulcus (mm)
次要结局
- Assessment of the influence of local antibiotic therapy on the radiological outcomes following periodontal regeneration procedures.(up to 12 months after treatment procedure)