The Effect of Chlorohexidine Gel on Tissue Healing Following Surgical Exposure of Dental Implants
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 主要终点
- Recession depth
研究概览
简要总结
The aim of this study is to evaluate the healing of peri-implat tissue following surgical uncovering with the adjunctive use of Chlorohexidine (CHX) gel.
详细描述
Patients who received implants in our department, and scheduled for surgical uncovering of the implants will be asked to participate in this clinical trial (40) Patients from Department of periodontology, Rambam Health campus, Haifa in Israel will be recruited to Randomized clinical trial; patients will be divided randomly in to 2 groups:
- Control: following uncovering of the implant a 4 mm height healing abutment will be screwed to the implant (the standard treatment modality) without using Chlorohexidine gel or any other gel.
- Test group: following implant exposure this group will receive Chlorohexidine 1% gel (Corsodyl®) the gel will be applied on the abutment as well as on the implant internal hex and then a 4 mm healing abutment will be connected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The study will be single blinded. The examiners of the clinical measurements, ELISA samples and the radiographs will be blinded to the patient's group.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who are willing to participate and willing to provide an informed consent.
- •Males and females between the ages 18-80
- •In good general health.
- •Patients who received dental implants and require implant uncovering (if there is more than 1 implant, a minimum radiographic distance of 3 mm will be required between implants).
排除标准
- •Uncontrolled Type 1 or type 2 diabetes patients( HbA1C>7).
- •Subjects treated for at least 2 weeks with any medication known to affect soft tissue condition within one month prior to baseline examination (e.g., Phenytoin, Cyclosporine, and chronic use of Bisphosphonates).
- •Patients who underwent guided bone regeneration during implant placement.
- •Patients who used antibiotic during the study or 4 weeks prior to the baseline.
- •Active periodontitis patients.
- •Subjects with presence of active systemic infectious diseases such as: Hepatitis, HIV, history of tuberculosis.
- •Pregnant or lactating females.
研究组 & 干预措施
Test group
following local anesthesia buccal and lingual flaps will be raised minimally, the cover screw will be removed from the implant .In the test group, Corsodyl gel 1% Chlorohexidine will be applied on the implant and the healing abutment. Healing abutment of 4 mm height will be screwed to the implant and flap will be sutured with silk 4-0 sutures.
Parallel radiograph will be taken after the surgery
干预措施: Corsodyl (Drug)
结局指标
主要结局
Recession depth
时间窗: 3 MONTHS
Distance from the healing abutment top to the free gingival margin will be measured by periodontal probe at the mid-buccal aspect of the healing abutment. Recession (Rec) is defined as the difference in millimeters between baseline to to 3 months .
次要结局
- PROBING DEPTH(3 MONTHS)
- Width of the keratinized mucosa (WKM)(3 MONTHS)
研究者
Hadar Zigdon MD
Dr.
Rambam Health Care Campus