Effect of Enamel Matrix Derivative (Emdogain®) on Soft Tissue Wound Healing Following Surgical Crown Lengthening Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Clinician-reported degree of inflammation
研究概览
简要总结
The goal of this randomized, controlled, single-center study is to compare the effects of Emdogain®, a regenerative biomaterial, on post-operative pain, wound healing and inflammation of treated sites after surgical crown lengthening. The main question it aims to answer is:
Does the use of Emdogain® in conjunction with crown lengthening surgery improve post-operative soft-tissue healing, decrease inflammation and reduce patient perception of pain compared to crown lengthening without addition of Emdogain®? The treatment group will receive Emdogain® during surgery, and the control group will undergo standard crown lengthening without Emdogain®.
详细描述
This randomized, controlled, single-center study intends to investigate the effects of Emdogain® on wound healing, postoperative pain and inflammation of treated sites after crown lengthening procedures on a single site, and to compare the results of this therapy with those of standard crown lengthening treatment on a single site. We have hypothesized that the use of Emdogain® in conjunction with crown lengthening surgery improves post-operative soft-tissue healing, decreases inflammation and reduces patient perception of pain compared to crown lengthening without addition of Emdogain®. Patients were recruited from the Graduate Periodontology clinic at the Faculty of Dentistry, University of Toronto. These patients were referred to the department by dental students in the faculty as well as dentists and dental specialists within the community for crown lengthening surgery, and were subsequently screened for eligibility to participate in the study. After confirmation of eligibility and completion of recruitment, patients were randomized, using a computer-generated randomization table, into the following groups:
- Treatment/experimental group: patients undergoing surgical crown lengthening of a single site with application of PrefGel® + Emdogain®
- Control group: patients undergoing surgical crown lengthening of a single site with application of PrefGel® only
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, Outcomes Assessor)
盲法说明
All participants remained blinded with respect to their group assignment for the duration of the study. Allocation concealment was done by placing randomization codes with group assignment in opaque sealed envelopes that were opened by the operator at the end of the surgical procedure, right before suturing, which means the surgeon was blinded throughout most of the treatment.
Data was collected by a separate examiner who was also blinded to treatment allocation. Data analysis was carried out by an external statistician, minimizing the risk of bias.
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:
- •Were capable and willing to provide consent and complete treatment as well as follow-up appointments
- •Were over the age of 18 years old
- •Required surgical crown lengthening for functional reasons as outlined in background
- •Had no contraindications to surgery (these include periodontal contraindications to crown lengthening such as poor crown-to-root ratio, furcation exposure or esthetic concerns)
排除标准
- •Patients who were unable to provide informed consent
- •Pregnant women
- •Women receiving estrogen therapy
- •Patients who had received systemic antibiotics within the past 6 months
- •Patients with severe systemic disease (ASA 3+) including: poorly controlled diabetes, blood dyscrasias, liver disease, immunosuppressive disorders, malignancy or who have had previous radiotherapy
- •Patients with untreated, active periodontal disease
结局指标
主要结局
Clinician-reported degree of inflammation
时间窗: One, two, four and eight-week follow-ups
Presence and degree of inflammation (appearance of erythema/edema) using VAS score
Clinician-reported quality of healing
时间窗: One, two, four and eight-week follow-ups
Overall healing using VAS score
Patient-reported perception of pain
时间窗: One, two, four and eight-week follow-ups
Pain score using VAS
Patient-reported swelling
时间窗: One, two, four and eight-week follow-ups
Swelling score using VAS
次要结局
- Number of analgesics(One, two, four and eight-week follow-ups)
研究者
Amir Azarpazhooh
Professor
University of Toronto