A Randomized Controlled Trial to Evaluate the Effect of Hyaluronic Acid on Infra-bony Defects: A Radiographic and Clinical Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in the Clinical Attachment Loss (CAL)
研究概览
简要总结
The aim of this study is to evaluate the effect of hyaluronic acid in the surgical treatment of periodontal pockets in people with gum disease.
This research consists of clinical and radiographic studies. Participants should have symmetric periodontal pockets in the upper or lower jaw.
Participants will be treated surgically using hyaluronic acid on one side of the jaw.
Clinical indexes and radiographic cone-beam computed tomographic (CBCT) images will be taken for each participant before surgical treatment and 12 months after surgical treatment.
详细描述
The aim of this study is to evaluate the effect of hyaluronic acid in the surgical treatment of infra-bony pockets in chronic periodontitis patients.
This research consists of clinical and radiographic studies.
1- The clinical study: is a randomized controlled trial with a split mouth technique.
Chronic periodontitis patients with Infra-bony pockets will be collected from the Department of Periodontics in faculty of dentistry - Damascus university.
Participants should have symmetric infra-bony pockets in the upper or lower premolar area with pocket probing depth more than 6 mm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic periodontitis
- •Symmetric Infra-bony defects with periodontal pocket depth more than 6 mm.
- •in upper or lower premolar area.
- •All participants will be collected from patients attending department of Periodontology - faculty of dentistry for periodontal disease treatment.
- •Males and females.
- •35-65 years old.
- •Systematically healthy.
- •Accepting to participate in the study. Informed written consent will be required.
排除标准
- •A history of previous scaling and root planning in the last 6 months
- •Pregnant women
- •Diabetes mellitus
研究组 & 干预措施
Open Curettage with Hyaluronic Acid
Hyaluronic Acid injection will be employed in conjunction with the ordinary surgical procedure.
干预措施: Hyaluronic Acid (Drug)
结局指标
主要结局
Change in the Clinical Attachment Loss (CAL)
时间窗: CAL will be measured at four times in this study: one week before surgical treatment, 3 months post-surgery, six months post-surgery and 12 months post-surgery
Clinical Attachment Loss (CAL): it is the distance between the cement-enamel junction of the tooth and the bottom of the pocket. CAL will be performed using a dental probe.
Vertical bone fill
时间窗: at 12 months post-surgery
Vertical bone fill: it is the distance between the base of the infra-bony defect and cement-enamel junction before surgery minus the distance between base of the infra-bony defect and cement enamel junction after surgery. It will be measured on CBCT images.
次要结局
- Mesiodistal distance(at 12 months post-surgery)
- Change in the Pocket Probing Depth (PPD)(PPD will be measured at four times in this study: one week before surgical treatment, 3 months post-surgery, six months post-surgery and 12 months post-surgery)
- Buccolingual distance(at 12 months post-surgery)
- Depth of infra-bony defect(at 12 months post-surgery)