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

Cairo University (CU)

Status: Not yet enrolling

Conditions: Gummy Smile Due to Hypermobile Upper Lip

Treatments: Procedure: Injection of cross linked hyaluronic acid filler

Study type: Interventional

Funder types: Other

Identifiers

NCT06952218

5699269

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 34 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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34 participants in 2 patient groups

Group I will receive botulinum toxin type A injection.

Active Comparator group

Description:

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.

Treatment:

Procedure: Injection of cross linked hyaluronic acid filler

Group II will receive cross linked hyaluronic acid filler injection

Experimental group

Description:

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.

Treatment:

Procedure: Injection of cross linked hyaluronic acid filler