Does Cyanoacrylate Require Supportive Suturing to Reduce Seconder Bleeding and Stabilizing Biomaterial at the Donor Site?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Donor site pain perception
研究概览
简要总结
An epithelialized gingival graft will be harvested from the palate for the treatment of various mucogingival deformities. The donor site will be treated with either a combination of a collagen sponge and cyanoacrylate or a collagen sponge, cyanoacrylate, and suspending sutures. Intraoperatively, measurements will be taken for palatal tissue thickness, graft dimensions, working time, and primary bleeding time. Data regarding pain perception will be gauged using a visual analog scale, and the number of analgesics, secondary bleeding, epithelization level, and color match will be assessed prospectively. These outcomes will be evaluated on the first 7 days and subsequently on the 14th, 21st, and 28th days. Patient-reported outcomes will be recorded using the Oral Health Impact Profile-14 questionnaire.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria:
- •mucogingival surgical treatment indication that needs connective tissue graft in the anterior mandible;
- •stable periodontium after phase I therapy;
- •full-mouth plaque and bleeding scores <15%
排除标准
- •previous palatal harvesting history;
- •unstable endodontic conditions;
- •tooth mobility at the surgical site;
- •systemic disease;
- •pregnancy;
- •use of medications with potential adverse effects on periodontal tissues
研究组 & 干预措施
gelatin sponge + cyanoacrylate + suspending sutures
After administration of local anesthesia (2% articaine hydrochloride with epinephrine 1:100,000), palatal thickness will be measured by perpendicularly inserting a Michigan-O periodontal probe from the corners of the rectangular donor area. Epithelialized gingival graft will be harvested. After a rectangular-shaped initial incision, a graft with 1-1.5 mm thickness will be harvested approximately 1.5 to 3 mm away from the gingival margins of the upper teeth. The donor site will be closed with a gelatin sponge + cyanoacrylate + suspending sutures.
干预措施: Gelatin sponge stabilization with suture and cyanoacrylate (Device)
gelatin sponge + cyanoacrylate
After local anesthesia (2% articaine hydrochloride with epinephrine 1:100,000) administration, palatal thickness will be measured by perpendicularly inserting a Michigan-O periodontal probe from the corners of the rectangular donor area and the mean value will be recorded as palatal tissue thickness. The epithelialized gingival graft will be harvested using 15 knives. After a rectangular-shaped initial incision, a graft with 1-1.5 mm thickness will be harvested approximately 1.5 to 3 mm away from the gingival margins of the upper teeth. The donor site will be closed with a gelatin sponge and cyanoacrylate without sutures.
干预措施: Gelatin sponge stabilization with cyanoacrylate (Procedure)
结局指标
主要结局
Donor site pain perception
时间窗: everyday in first week
Patients score their daily donor site pain perception using visual analog score level by giving numbers from 0 to 10 according to the visual analog scale (0: no pain, 1: minimal pain, 10: severe pain)
Secondary bleeding time
时间窗: during first week
Patients will record presence or absence of secondary bleeding (presence=1 or absence=0).
次要结局
- Graft thickness(during surgery)
- Working time(during surgery)
- Graft width(during surgery)
- Epithelization level(first week, second week, third week, fourth week.)
- Graft height(during surgery)
- Color match(first week, second week, third week, fourth week.)
- The Oral Health Impact Profile-14 is a questionnaire that measures how oral disorders impact a patient's quality of life.(first week)
- Quantity of analgesics(first week)
- Sensation loss(first week, second week , third week, fourth week.)
研究者
Gencay Keceli
Assoc. Prof. Dr.
Hacettepe University