Effect of Cyanoacrylate Tissue Adhesive Versus Collagen Sponge on Palatal Donor Site Healing After Harvesting a Free Gingival Graft: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Healing of palatal wound
研究概览
简要总结
The goal of this clinical trial is to learn if the use of cyanoacrylate glue (PeriAcryl) is effective in healing of the palatal donor site in adults requiring a free gingival graft.
The main question[s] it aims to answer [is/are]:
Does PeriAcryl accelerate the palatal tissue healing compared with the use of collagen sponge? Does PeriAcryl usage leave the patients more satisfied?
Researcher will compare the outcomes of participants treated with PeriAcryl to those treated with collagen sponge to see if PeriAcryl accelerated the healing process of palatal tissues and led to fewer postoperative complications.
Participants will:
- be assigned to a study group using PeriAcryl or control group using Collagen sponge.
- be followed-up to monitor healing and gather clinical information.
详细描述
This study investigates new approaches to make management of the palatal donor area easier to the operator and more comfortable to the patient. More specifically, it compares the use of PeriAcryl glue (PA) to the use of collagen sponge after harvesting a free gingival graft from the palate in terms of wound healing and epithelization primarily, and patients satisfaction and oral health related quality of life secondarily.
Participants selection:
Healthy patients (with no systemic diseases or coagulation disorders) requiring a free gingival graft to treat a gingival recession or keratinized tissue deficiency around implants and natural teeth will be recruited.
Participants included in this study must have clinically healthy gingiva and good oral hygiene.
Participants grouping:
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
- None
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
- •Low-moderate anesthetic risk (ASA I-II)
- •No restriction on ethnicity or gender
- •Patients requiring FGG from the palate for periodontal plastic surgery
- •Clinically healthy gingiva after phase I therapy
- •Full-mouth plaque index grades 0 and 1
- •Bleeding scores <15%
排除标准
- •Patients who smoke > 10 cigarettes/day
- •Patients with coagulation disorders
- •Systemic diseases
- •Patients on certain medications that may affect periodontal tissues
- •Pregnant and lactating patient
- •Patients with allergies to drugs that will be prescribed during the treatment phase
- •Pathological mental conditions (dementia, psychosis) and lack of cooperation
- •Excessive gag reflex
结局指标
主要结局
Healing of palatal wound
时间窗: 1 month, 2 months and 3 months post-operatively.
Healing will be evaluated using Laundry Wound Healing Index (WHI). WHI has a score range of 1 (very poor) to 5 (excellent), evaluates tissue color, response to palpation, presence of granulation tissue, epithelialization of incision margins, and amount of suppuration.
Epithelization of the palatal wound
时间窗: On every follow-up session: 7 days, 14 days, 21 days, 1 month, 2 months and 3 months post-operatively.
The complete epithelialization will be evaluated clinically by applying 3% hydrogen peroxide into the palatal wound. If bubble formation is not observed, epithelization will be recorded as complete, whereas if bubbles are observed, epithelization will be recorded as incomplete.
Color Match
时间窗: 3 months post-operatively
Tissue color match (CM) will be assessed with adjacent and contralateral palatal tissue (0-no color matching to 10-excellent color matching).
次要结局
- Number of Analgesic Pills Taken(During the first 14 days post-operatively.)
- Oral Health related Quality of Life(During the first 14 days post-operatively.)
- Inflammation Degree(Every day for 7 days, and on the 14th day.)
- Post-operative Bleeding(Every day for 7 days, and on the 14th day.)
- Presence of Hyperesthesia(Every day for 7 days, and on the 14th day.)
- Number of Analgesic Pills Taken(During the first 14 days post-operatively.)
- Post-operative Pain(Every day for 7 days, and on the 14th day.)
- Oral Health related Quality of Life(During the first 14 days post-operatively.)