A Randomized Controlled Trial Evaluating Hyaluronic Acid As a Wound Healing Agent Following Alveolar Ridge Preservation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Wound reduction
研究概览
简要总结
After tooth extraction, shrinkage of the bone is expected after 6 months. These changes may hamper dental implant placement and compromise soft tissue aesthetics. Alveolar Ridge Preservation (ARP) includes application of bovine-derived deproteinized bone particles in the extraction site. This technique is widely performed and drastically limits aforementioned volumetric changes.
The amount of bone preservation following ARP is affected by the soft tissue barrier. In an open healing situation, it takes about 4 weeks to have complete soft tissue closure. Faster soft tissue closure could optimize the amount of bone preservation with obvious benefits for implant placement and aesthetics.
Recent presentations showed the application of hyaluronic acid after ARP. However, no evidence can be found in the literature. This study aims to evaluate the wound healing potential of hyaluronic acid following ARP, as this has never been performed, yet seems promising from a biological point of view.
详细描述
Aim:
This study aims to evaluate the wound healing potential of hyaluronic acid (HA) following alveolar ridge preservation (ARP), as this has never been performed, yet seems promising from a biological point of view.
Sample size calculation:
A sample size calculation using a two-sample pooled t-test was performed in SAS Power and Sample Size based on a comparison of mean overall wound reduction from baseline to 21 days between the control and test group. The calculation was based on finding a mean difference of 20% between these groups with a standard deviation of 21.6 for the control and 21.6 for the test group. A pilot study was executed to obtain these findings as no other data are available. With alpha set at 0.05 and a power of 0.08, the sample size calculation indicated 19 patients to be included per group. To compensate for drop-outs, 25 would be treated with hyaluronic acid and 25 would be treated without.
Clinicians and centers, randomization, allocation concealment and blinding:
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 (Care Provider, Outcomes Assessor)
盲法说明
Patients will be randomly allocated to the 'test group (Hyaluronic acid)' or the 'control group (No hyaluronic acid). An equal number of sealed envelopes will be prepared internally labelled as 'test group' or 'control group'. Just after alveolar ridge preservation, a sealed envelope will be randomly selected and opened to reveal further treatment.
The measuring investigator will not be involved in the treatment of any of the patients and will be blinded to allow unbiased registrations.
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
- •At least 18 years old;
- •Good oral hygiene defined as a full-mouth plaque score ≤25%;
- •One or two neighboring teeth;
- •Need for ARP after tooth extraction with >50% buccal bone still present
排除标准
- •Systemic diseases;
- •(History) of periodontal disease;
- •Untreated caries lesions
研究组 & 干预措施
Control
No further treatment after alveolar ridge preservation
Test
In case the test group comes out, instructions for the daily application of hyaluronic acid (Gengigel Forte©) will be given. Hyaluronic acid will be administered by the patient 3 times per day during 7 days.
干预措施: Gengigel Forte© (Device)
结局指标
主要结局
Wound reduction
时间窗: Week 3 after ARP
performed by measuring the maximum mesio-distal and bucco-oral dimension of the wound immediately after ARP and after 21 days
次要结局
- Compliance(Week 1)
- Number of painkillers consumed(Week 1)
- VAS pain(Week 1)
- VAS swelling(Week 1)
- Bleeding(Week 1)
- Socket wound healing score(Week 1 and 3)
- Mucosal scarring index(4 months)
- Dimensional changes in the buccal soft tissue profile(At time of surgery and at 4 months)
- Dimensional changes of the alveolar process(Immediately after surgery and at 4 months)