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临床试验/NCT06952218
NCT06952218尚未招募不适用

Effect of Cross-linked Hyaluronic Acid Filler Versus Botulinum Toxin Type A (Botox) in Management of Gummy Smile: Randomized Controlled Clinical Trial

Cairo University2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2025年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
34
试验地点
2
主要终点
Gingival display

研究概览

简要总结

A smile is supposed to express one's feelings and expressions, for that there has been an awakening concern for the appearance of gummy smile. Gummy smile is the appearance of about 2mm or more of the gingiva during smiling. It may affect the quality of life of individuals affecting their self-esteem; patients desire to look good not only while resting but while dynamically expressing themselves too. Variable factors contribute to this gingival display whether skeletal, dental or muscular. Variable treatment modalities are done solely or in adjunction to each other for the treatment of gummy smile including both surgical or nonsurgical procedures.

详细描述

In patients not preferring surgical correction of gummy smile, botulinum toxin injection type A can be a helpful solution for reduction of peri-oral muscular hypermobility. A characteristic feature of botulinum toxin is the need for the re-injection in short intervals of time to yield better lasting effects. The use of cross-linked hyaluronic acid dermal fillers when used to myomodulate the peri-oral muscles give more immediate results and reduces the need for re-injection at shorter intervals.

Botulinum toxin type A, a toxin produced by the bacteria Clostridium botulinum, has been widely used in different therapeutic and cosmetic applications in dentistry. Amongst its important applications is the treatment of gummy smile by reducing the hypermobility of the peri-oral muscles through chemical denervation. Botox elicits temporary results and requires re-injection at certain time points. It is a safe, suitable, transient solution for patients not willing to undergo any surgical intervention to manage their gummy smile. Another approach for the non invasive treatment of muscular hypermobility is the injection of cross linked hyaluronic acid filler. Once the filler is injected, it typically occupies space that lessens the muscle movement limiting its hypermobility. Instant Smile enhancement is observed upon injection of cross-linked hyaluronic acid fillers and no need to repeat the injection at closer periods of time. Hyaluronic acid fillers are non-permanent fillers that are degradable by hyaluronidase and cross linking renders them more resistant to enzymatic degradation thus lasting longer.

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
Triple (Participant, Investigator, Outcomes Assessor)

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

  • •Patients with excessive gingival display ranging from 3-8mm due to hypermobile lip.
  • •Age ranges from 18 years or above.

排除标准

  • •Excessive gingival display due to other etiological factors.
  • •Patients allergic to botox or hyaluronic acid fillers.
  • •Patients with any medical condition that contraindicates botox or hyaluronic acid filler injection.
  • •Patients previously injected with permanent fillers.
  • •Pregnancy.
  • •Breastfeeding females.
  • •Patients with active inflammatory or infectious disease at intended site of injection.

研究组 & 干预措施

Group I will receive botulinum toxin type A injection.

Active Comparator

Injection site will be determined at a point in which the elevator muscles of the upper lip which are levator labii superioris, levator labii superioris alaeque nasi, and zygomaticus minor converge into the lateral area of the ala of the nose. The center of intersection of the mentioned muscles is termed Yonsei Point and estimated to be at a 1cm horizontal distance from the ala of the nose and a 3cm vertical distance from the lip line. Lidocaine 5% ointment will be applied to the intended injection site for 20 mins. In control group, 2.5 units of botulinum toxin will be injected bilaterally at Yonsei Point. An insulin needle will be used for injecting the botox.

干预措施: Injection of cross linked hyaluronic acid filler (Procedure)

Group II will receive cross linked hyaluronic acid filler injection

Experimental

Lidocaine 5% ointment will be applied to the intended injection site for 20 mins. In intervention group, a bolus of 0.2 ml of 20% cross linked hyaluronic acid filler will be injected in canine fossa region using a 29G needle preceeded by aspiration for 10 seconds ensuring no blood vessel will be involved.

干预措施: Injection of cross linked hyaluronic acid filler (Procedure)

结局指标

主要结局

Gingival display

时间窗: week 2, month 1, month 3, month 6, month 9

will be measured from a point denoting the lowest margin of the upper lip perpendicular and superior to the midportion of the gingival margin of the maxillary lateral incisor to the gingival margin at the midpoint of the maxillary lateral incisor. The midpoint of the incisal edge of the maxillary lateral incisor will be used as a reference point if the upper lip fell below the gingival margin of the same tooth post-injection (Diaspro, Cavallini et al. 2018).

次要结局

  • Patient satisfaction(week 2, month 1, month 3, month 6, month 9)
  • Postoperative pain(week 2, month 1, month 3, month 6, month 9)
  • Lip mobility(week 2, month 1, month 3, month 6, month 9)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Raghda Hussein Metwaly Mahmoud

Masters Candidate

Cairo University

研究点 (2)

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