The Effectiveness of Nano Bio Fusion Gel (NBF) on Early Wound Healing at the Palate (Donor Site) After Soft Tissue Graft Surgery Compared to Placebo Gel: a Double Blinded Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Wound area
研究概览
简要总结
The goal of this clinical trial is to assess the effect of Nano-biofusion gingival gel (NBF) on wound healing at the palatal donor site following soft tissue graft surgery and compare it to placebo gel. The main questions it aims to answer are:
- Does NBF gel enhance wound healing after graft harvesting from the palate?
- Does NBF gel reduce the number of inflammatory mediators after surgery?
- Does NBF gel reduce pain and discomfort at the palatal donor site? Researchers will compare NBF gel to a placebo (a look-alike gel that does not contain the active ingredients) to see if NBF gel enhances wound healing.
Study steps include:
- Participants will apply the assigned gel on the surgical wound 4 times a day for 4 weeks.
- Clinical photographs and measurements will be obtained on days (0, 1, 2, 4, 7, 15, 21, 30).
- Wound fluid samples will be collected on days (0, 1, 2, 4, 7).
- Participants will be asked about the level of pain and analgesic consumption on each follow-up visit.
详细描述
A sample size of 36 subjects, with treated 18 sites in each group should be sufficient to detect a mean difference of 1 mm of the wound area between groups. Efforts will be made to balance the number of men and women in each group (if possible).
The participants will be recruited from patients coming to dental teaching clinics at Jordan University of Science and Technology. The patients will be randomly assigned into 2 groups using computer generated randomization sequence:
Group 1: placebo gel Group 2: NBF gel
The study's purpose and procedures will be clearly communicated to all patient. Prior to examination and treatment, each participant must sign a consent form.
Patients who require a soft tissue surgery to cover gingival recession around teeth, to modify the phenotype where there is a thin gingival tissue, or to increase the width and thickness of soft tissue will be included in the study. The soft tissue graft should be obtained from the palatal donor site by free gingival graft or depithelized connective tissue graft, leaving an open wound in the palate (around 3×6 mm size) that is going to heal by secondary intesntion.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The gel will be provided in a small opaque tube. The clinician and the patient will be blinded to the type of gel used. Other doctor or dental assistant will be responsible for dispencing the gel to the patient according to the randomization sequence and the code sheet.
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 with gingival recession that is indicated for root coverage or need for phenotype modification.
- •18 years or older.
- •absence of systemic disease
- •No use of antibiotics, corticosteroids, anti-inflammatory medication or hormones in the past 3 months
排除标准
- •Pregnant or lactating woman.
- •patients with immune or systemic diseases.
- •Patients with an allergy to any ingredient in the gel.
研究组 & 干预措施
Nano bio-fusion gingival gel (NBF)
The gel should be applied 4 times daily for 4 weeks. After drying the surgical site in the palate with a sterile gauze, a pea size of the gel material is applied to the wound using cotton applicator. If there is a vertical relasing incision in the recipient site, the gel will be applied using the same technique.
干预措施: Application of NBF gel after soft tissue graft surgery (Drug)
placebo gel
The gel should be applied 4 times daily for 4 weeks. After drying the surgical site in the palate with a sterile gauze, a pea size of the gel material is applied to the wound using cotton applicator. If there is a vertical relasing incision in the recipient site, the gel will be applied using the same technique.
干预措施: Application of placebo gel after soft tissue graft surgery (Other)
结局指标
主要结局
Wound area
时间窗: On each follow up visit: T1 (24 hours after the surgery), T2 (2 days after the surgery), T3 (4 days after the surgery), T4 (7 days after the surgery), T5 (15 days after the surgery), T6 (21 days after the surgery), T7 (30 days after the surgery)
The wound area of the palatal donor site will have a rectangular shape, and it will be measured in mm according to the following equation: Area = length × width UNC15 periodontal probe will be used to do the measurements at the greatest dimension horizontally and vertically. The site will be left to heal by secondary intension.
次要结局
- Present or abscent (Yes/no):(On each follow up visit: T1 (24 hours after the surgery), T2 (2 days after the surgery), T3 (4 days after the surgery), T4 (7 days after the surgery), T5 (15 days after the surgery), T6 (21 days after the surgery), T7 (30 days after the surgery))
- Erythema, redness + edema, swelling(On each follow up visit: T1 (24 hours after the surgery), T2 (2 days after the surgery), T3 (4 days after the surgery), T4 (7 days after the surgery), T5 (15 days after the surgery), T6 (21 days after the surgery), T7 (30 days after the surgery))
- Epithelization and exposure of CT(On each follow up visit: T1 (24 hours after the surgery), T2 (2 days after the surgery), T3 (4 days after the surgery), T4 (7 days after the surgery), T5 (15 days after the surgery), T6 (21 days after the surgery), T7 (30 days after the surgery))
- Incision margins(On each follow up visit: T1 (24 hours after the surgery), T2 (2 days after the surgery), T3 (4 days after the surgery), T4 (7 days after the surgery), T5 (15 days after the surgery), T6 (21 days after the surgery), T7 (30 days after the surgery))
- Patient reported outcome measure (PROM)(On each follow up visit: T1 (24 hours after the surgery), T2 (2 days after the surgery), T3 (4 days after the surgery), T4 (7 days after the surgery), T5 (15 days after the surgery), T6 (21 days after the surgery), T7 (30 days after the surgery))
- cytokine measurement using ELISA test(Immediately after surgery and wound closure (day 0) and on days (1, 2, 4, 7). They will not be collected at days 15, 21, and 30 as the wound should be closed by then, unless there is delayed wound healing and the fluid can be collected from the wound.)
- Early wound healing index (EWHI)(On each follow up visit: T1 (24 hours after the surgery), T2 (2 days after the surgery), T3 (4 days after the surgery), T4 (7 days after the surgery), T5 (15 days after the surgery), T6 (21 days after the surgery), T7 (30 days after the surgery))
研究者
Lana Bader
assistant professor
King Abdullah University Hospital