Comparison of Vertical Releasing Incisions and Horizontal Extending Incisions for Periodontal Accelerated Osteogenic Orthodontics in the Anterior Region: A Randomized Controlled Trial With Surgical Time, Clinical and Radiographic Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Surgery Time
研究概览
简要总结
The study aims to compare the effect of periodontal accelerated osteogenic orthodontics (PAOO) with horizontal or vertical releasing incisions on operation time, healing, adverse effects, and effectiveness of bone augmentation.
Methods: A total of 22 patients requiring PAOO surgery due to orthodontic treatment were enrolled in this trial, and randomly divided into test or control group, consisting of 11 subjects in each. The test group will receive PAOO with horizontal extending incisions on both sides of the flap; while the control group will receive PAOO with vertical releasing incisions; the two groups use the same surgical technic except for the incision design. Outcome measures include: operation time, postoperative scar, radiographic data (alveolar height and alveolar ridge thickness), gingival thickness, etc. Clinical evaluation will be performed at 1 week, 2 weeks, 3months, 6 months and 12 months after operation.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 40 years old, systemic healthy, undergoing or planning to undergo orthodontic treatment.
- •Patients with a thin alveolar bone or with dehiscence and/or fenestration on the labial side of maxillary or mandibular front teeth area.
- •Patients with expected tooth movement beyond the labial alveolar bone during orthodontic procedures.
排除标准
- •Pregnant or lactating.
- •Untreated periodontitis.
- •Presence of <2mm keratinized gingival width(KGW) or thin gingival phenotype (as defined by dental probe transparency.)
- •History of orthodontic and/or orthognathic treatment.
- •With systemic disease (diabetes, hypertension, heart disease, malignant tumor, severe mental illness, and other surgical contraindications.)
- •Long-term medication (immunosuppressive drugs, bisphosphonates, etc.)
- •Poor adherence to complete one-year follow-up.
结局指标
主要结局
Surgery Time
时间窗: 1 day
Timing will start when the first incision is about to be made, and end when the last suture is complete. The time in between will be recorded as surgery time.
次要结局
- Probing Depth (PD)(12 months)
- Clinical Attachment Level (CAL)(12 months)
- Keratinized Gingival Width (KGW)(12 months)
- Gingival Recession Depth (GRD)(12 months)
- Root Length(12 months)
- Vertical Bone Height (VBL)(12 months)
- Alveolar Bone Width Measured at 2 mm Below the CEJ (BW2)(12 months)
- Alveolar Bone Width Measured at 4 mm Below the CEJ (BW4)(12 months)
- Alveolar Bone Width Measured at 6 mm Below the CEJ (BW6)(12 months)
- Number of Participants With Visible Scarring(12 months)
- Pain Level(2 weeks)
- Membrane Exposure(2 weeks)
- Facial Swelling(2 weeks)
- Mucosal Color(2 weeks)
- Mucosa Edema(2 weeks)