Comparative Evaluation of Milled Polyether Ether Ketone (PEEK) Stent Placement and Lip Repositioning Surgery on the Treatment of Gummy Smile (A Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Postoperative pain assessment
研究概览
简要总结
The objective of this study is to compare between a Polyether ether ketone (PEEK) stent - and standard lip repositioning technique for management of gummy smile
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systemically healthy individuals
- •Chiefs complain gummy smile
- •Gummy smile due to short hypermobile upper lip
- •Gingival Display not more than 5 mm
排除标准
- •Pregnancy
- •Lactation
- •History of smoking more than 10 cigarettes per day
- •Systemic conditions or intake of medications that could affect soft and hard tissue healing
- •Use of orthodontic appliances
- •Gingival display above 5mm
研究组 & 干预措施
VISTA and Milled PEEK stent
干预措施: Milled PEEK Stent (Other)
Lip repositioning surgery
干预措施: Lip repositioning surgery (Procedure)
结局指标
主要结局
Postoperative pain assessment
时间窗: up to one week
Postoperative pain will be evaluated at first and seventh day using numeric rating scale (NRS). Patient will rate his pain on a scale from 0 to 10, with 0 indicating no pain and 10 reflecting the worst possible pain. * 0 = no pain * 1-3 = mild pain * 4-6 = moderate pain * 7-10 = severe pain
Facial Edema (Swelling)
时间窗: up to one week
Postoperative edema was measured with a flexible tape measure by calculating the distance between several facial landmarks and comparing them to preoperative values.
Gingival display
时间窗: up to 6 months
Distance from gingival margin to lower border of upper lip vermilion border will be measured
Healing Quality
时间窗: up to 3 weeks
Measured according to Landry's Healing Index which records healing on basis of tissue colour, bleeding, ulceration, granulation tissue and epithelisation. Scores range from 1 (Very poor) to 5 (excellent)
Gingival display
时间窗: up to 9 months
Distance from gingival margin to lower border of upper lip vermilion border will be measured
次要结局
未报告次要终点
研究者
taher helmy ismail metwaly
MSc. Candidate in Periodontology
Alexandria University