Management of Pain and Facial Edema Following Bimaxillary Orthognathic Surgery: Kinesio Taping Versus Rigid Compression Taping: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Postoperative Pain Intensity
研究概览
简要总结
Postoperative facial swelling and pain are common complications following corrective jaw surgery (bimaxillary orthognathic surgery). This randomized controlled trial aimed to determine whether elastic therapeutic taping (Kinesio taping) applied using a mechanical correction technique is more effective than standard rigid compression taping in reducing acute postoperative pain and facial swelling. The study also evaluated changes in oral health-related quality of life.
A total of 36 adult patients undergoing elective bimaxillary orthognathic surgery were randomly assigned into two equal groups (18 participants per group):
Kinesio Taping Group: Participants received bilateral elastic Kinesio taping applied with a mechanical correction technique.
Rigid Compression Taping Group: Participants received bilateral rigid compression taping over the surgical facial area.
Both taping applications were initiated immediately following surgery and maintained for 7 days, with tape replacement on the third postoperative day. All participants received identical standardized postoperative medication and cryotherapy protocols. Pain intensity was measured using a Visual Analog Scale (VAS) across 7 days, facial swelling was assessed through bilateral landmark tape measurements across 7 days, and quality of life was evaluated using the Orthognathic Quality of Life Questionnaire (OQLQ) through 3 weeks post-surgery.
详细描述
This prospective, two-arm, parallel-group randomized controlled trial was conducted at Ankara University Faculty of Dentistry following ethical approval from Gazi University.
Participants scheduled for elective bimaxillary orthognathic surgery-consisting of Le Fort I maxillary osteotomy and bilateral sagittal split osteotomy (BSSO) of the mandible-were allocated in a 1:1 ratio using a computer-generated simple randomization sequence.
Standardized Perioperative Care:
All participants underwent standardized bimaxillary surgery under general anesthesia. Postoperatively, all patients received a uniform medication regimen including amoxicillin/clavulanic acid (or alternative if allergic), chlorhexidine mouthwash, routine paracetamol, weight-based methylprednisolone tapering, rescue analgesia (dexketoprofen trometamol as needed), a decongestant preparation, and gastric protection. In addition, standardized intermittent bilateral cryotherapy (5 minutes on, 5 minutes off) was administered during the first 24 hours.
Intervention Protocols:
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
盲法说明
Due to visible differences between elastic Kinesio tape and rigid compression tape, participants, the treating physiotherapist, and the outcome assessor could not be blinded to group allocation. The surgical team remained unaware of group allocation during the surgical procedure because the interventions were applied only after surgery was completed
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age older than 18 years Scheduled to undergo elective bimaxillary orthognathic surgery consisting of Le Fort I maxillary osteotomy and bilateral sagittal split osteotomy of the mandible Provided written informed consent
排除标准
- •Receiving regular medication Diagnosed mental disorder Coagulopathy Diabetes mellitus Chronic infection
研究组 & 干预措施
Kinesio Taping Group
Participants received bilateral facial Kinesio taping (standard width 5 cm) applied using the mechanical correction technique with 75%-100% tension in the correction zone. Taping was applied immediately after orthognathic surgery, renewed on postoperative day 3, and maintained for 7 days alongside standardized postoperative medication and cryotherapy protocols.
干预措施: Kinesio Taping (Other)
Rigid Compression Taping Group
Participants received bilateral rigid compression taping applied firmly over the postoperative facial region to provide mechanical compression and support. Taping was applied immediately after orthognathic surgery, renewed on postoperative day 3, and maintained for 7 days alongside standardized postoperative medication and cryotherapy protocols.
干预措施: Rigid Compression Taping (Other)
结局指标
主要结局
Postoperative Pain Intensity
时间窗: Postoperative hours 6, 12, 24, and postoperative days 2, 3, and 7
Pain intensity was evaluated using a 100-mm Visual Analog Scale (VAS), where 0 represents "no pain" and 100 represents "the worst imaginable pain" (higher scores indicate greater pain intensity). Evaluated at 6, 12, 24 hours and days 2, 3, and 7 post-surgery.
Facial Edema
时间窗: Preoperative baseline, immediately postoperative, and postoperative days 2, 5, and 7
Facial edema was quantified using a flexible millimeter tape across seven standardized bilateral linear facial reference distances: tragus-labial commissure, tragus-pogonion, tragus-lateral canthus, gonion-lateral canthus, gonion-nasion, gonion-pogonion, and tragus-nasal alar crest (measured in millimeters; increases reflect greater facial edema). Evaluated preoperatively, immediately after surgery, and on days 2, 5, and 7 post-surgery.
次要结局
- Oral Health-Related Quality of Life(Preoperative baseline, and postoperative weeks 1 and 3)
研究者
Gamze COBANOGLU
Assistant Professor
Gazi University