The Influence of Tissue Adhesive to Palatal Donor Site Healing. A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Donor site pain perception (PP)
研究概览
简要总结
CTG was harvested from 21 patients in each group. Donor site was treated with either GS (control) or GS+CY (test). Palatal tissue thickness, graft dimensions, working time (WT) and primary bleeding time were recorded intraoperatively. The data of pain perception (PP) will be measured using visual analog scale, quantity of analgesics (QA), secondary bleeding (SB), epithelization level (EL), and color match (CM) will be assessed prospectively. these outcomes will be evaluated in the first 7 days and 14th, 21th, and 28th days. Patient reported outcomes will be recorded using OHIB 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
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
One author (H.G.K.) randomly assigned the patients, with 1:1 allocation ratio, into GS and GS+CY groups by making simple randomization without blocking (computer-generated randomization scheme) (Figure 1). Number-labeled opaque envelopes containing the name of assigned method were used for allocation concealment. The surgical procedures were carried out by (B.T.Y.) whereas another author (E.C.) acquired the intra- and post-operative data. No information regarding to the applied hemostatic was given to the patients to preserve the patient blinding.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PPS indication that needs CTG in 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 surgical site;
- •systemic disease;
- •pregnancy;
- •use of medications with potential adverse effects to periodontal tissues
研究组 & 干预措施
Gelatine Sponge
After local anesthesia (2% articaine HCl with epinephrine 1:100,000) administration, palatal thickness was measured by perpendicularly inserting a Michigan-O periodontal probe from the corners of the rectangular donor area and mean value was recorded as 'palatal tissue thickness (PTT)'. Epithelialized gingival graft was harvested with the method described by Zucchelli et al.19 After a rectangular shaped initial incision, graft with 1-1.5 mm thickness was harvested approximately 1.5 to 3 mm away from gingival margins of upper teeth. After harvesting, excess fatty tissues were removed and de-epithelialization was performed to obtain DGG. Donor site was closed either with GS (Spongostan®, Ethicon, Somerville, USA)
干预措施: Gelatin Sponge;Thrombin, Bovine 5000 IU Multiple Routes Kit [GELFOAM-JMI SPONGE KIT] (Drug)
Gelatine sponge +Cyanoacrylate
After local anesthesia (2% articaine HCl with epinephrine 1:100,000) administration, palatal thickness was measured by perpendicularly inserting a Michigan-O periodontal probe from the corners of the rectangular donor area and mean value was recorded as 'palatal tissue thickness (PTT)'. Epithelialized gingival graft was harvested with the method described by Zucchelli et al.19 After a rectangular shaped initial incision, graft with 1-1.5 mm thickness was harvested approximately 1.5 to 3 mm away from gingival margins of upper teeth. After harvesting, excess fatty tissues were removed and de-epithelialization was performed to obtain DGG. Donor site was closed either with GS (Spongostan®, Ethicon, Somerville, USA) and GS covered with high viscosity CY (PeriAcryl®, Glustitch Inc., Delta, Canada) (GS+CY group)
干预措施: Cyanoacrylate, Isobutyl (Drug)
结局指标
主要结局
Donor site pain perception (PP)
时间窗: first week
Patients score their daily donor site pain perception (PP) level by giving numbers from 0 to 10 according to the visual analog scale (VAS) (0: no pain, 1: minimal pain, 10: severe pain)
次要结局
- Primary bleeding time (PBT)(during surgery)
- Graft height (GH)(during surgery)
- Graft width (GW)(during surgery)
- Graft thickness (GT)(during surgery)
- Working time (WT)(during surgery)
- Quantity of analgesics (QA)(first week)
- Secondary bleeding (SB)(first week)
- Sensation loss (SL)(first week, second week , third week, fourth week.)
- Color match (CM)(first week, second week, third week, fourth week.)
- Epithelization level (EL)(first week, second week, third week, fourth week.)
研究者
Gencay Keceli
Assoc. Prof. Dr.
Hacettepe University