Clinical Study to Evaluate the Effects of a Topical Hyaluronic Acid (HA) Gel on Postoperative Pain and Wound Healing at Palatal Donor Sites in Subjects Undergoing Mucogingival Procedures
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
- Wound healing area
研究概览
简要总结
This clinical study aims to investigate the impact of a topical hyaluronic acid (HA) gel on postoperative pain and wound healing at palatal donor sites in patients undergoing mucogingival procedures involving a de-epithelialized gingival graft (DGG) from the palate. The study design is a Phase III, randomized, double-blind, parallel-group, clinical trial, conducted in a single center, with 30 subjects aged 18-70 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females, between 18-70 years of age
- •Informed Consent Form signed and availability for the duration of the study
- •Good general health (absence of any condition that, in the opinion of the Principal Investigator, might constitute a risk to the subject while participating in the study
- •Clinical indication for mucogingival surgery that requires a de-epithelialized gingival graft (DGG) from the palate
- •Willingness to provide information related to their medical history
- •Minimum of 10 uncrowned permanent natural teeth (excluding third molars)
- •Normal salivary flow
排除标准
- •Oral pathology, chronic disease, or a history of allergy to testing products
- •Subject using anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory medication or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study
- •Subject participating in any other clinical study
- •Subject pregnant or breastfeeding
- •Subject allergic to oral care products, personal care consumer products, or their ingredients
- •Extended use of antibiotics or therapeutic mouthwash any time during the three months prior to entry into the study
- •A medical history reporting that the subject has a current systemic or autoimmune disease, such as diabetes, lupus, etc
- •Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine)
研究组 & 干预措施
Group II
A hemostatic sponge alone
干预措施: Control (Device)
Group I
A gel containing Hyaluronic acid in combination with a hemostatic sponge
干预措施: Hyaluronic acid (Device)
结局指标
主要结局
Wound healing area
时间窗: 42 days after surgery
Wound size will be assessed at Baseline after obtaining the graft, and 3, 7, 14, 21, and 42 days after surgery via direct measurement with a Periodontal Probe UNC 15 (Hu-Friedy, United States), length and height of the wound will be measured and recorded to the nearest millimeter
Wound healing area
时间窗: 21 days after surgery
Wound size will be assessed at Baseline after obtaining the graft, and 3, 7, 14, 21, and 42 days after surgery via direct measurement with a Periodontal Probe UNC 15 (Hu-Friedy, United States), length and height of the wound will be measured and recorded to the nearest millimeter
Wound healing area
时间窗: Baseline
Wound size will be assessed at Baseline after obtaining the graft, and 3, 7, 14, 21, and 42 days after surgery via direct measurement with a Periodontal Probe UNC 15 (Hu-Friedy, United States), length and height of the wound will be measured and recorded to the nearest millimeter
Wound healing area
时间窗: 3 days after surgery
Wound size will be assessed at Baseline after obtaining the graft, and 3, 7, 14, 21, and 42 days after surgery via direct measurement with a Periodontal Probe UNC 15 (Hu-Friedy, United States), length and height of the wound will be measured and recorded to the nearest millimeter
Wound healing area
时间窗: 7 days after surgery
Wound size will be assessed at Baseline after obtaining the graft, and 3, 7, 14, 21, and 42 days after surgery via direct measurement with a Periodontal Probe UNC 15 (Hu-Friedy, United States), length and height of the wound will be measured and recorded to the nearest millimeter
Wound healing area
时间窗: 14 days after surgery
Wound size will be assessed at Baseline after obtaining the graft, and 3, 7, 14, 21, and 42 days after surgery via direct measurement with a Periodontal Probe UNC 15 (Hu-Friedy, United States), length and height of the wound will be measured and recorded to the nearest millimeter
次要结局
- Pain assessment(42 days after surgery)
- Pain assessment(Baseline)
- Pain assessment(3 days after surgery)
- Pain assessment(7 days after surgery)
- Pain assessment(14 days after surgery)
- Pain assessment(21 days after surgery)