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

NCT ID: NCT06952218

Last Updated: 2025-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2025-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gummy Smile Due to Hypermobile Upper Lip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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. 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. The product will be infiltrated slowly keeping an angle of 90 degrees in relation to the bone.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group I will receive botulinum toxin type A injection.

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.

Group Type ACTIVE_COMPARATOR

Injection of cross linked hyaluronic acid filler

Intervention Type PROCEDURE

Injection of cross linked hyaluronic acid filler

Group II will receive cross linked hyaluronic acid filler injection

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.

Group Type EXPERIMENTAL

Injection of cross linked hyaluronic acid filler

Intervention Type PROCEDURE

Injection of cross linked hyaluronic acid filler

Interventions

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Injection of cross linked hyaluronic acid filler

Injection of cross linked hyaluronic acid filler

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Raghda Hussein Metwaly Mahmoud

Masters Candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CairoU

Cairo, , Egypt

Site Status

Cairo University

Giza, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Raghda Hussein

Role: CONTACT

Phone: 01122642622

Email: [email protected]

Other Identifiers

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5699269

Identifier Type: -

Identifier Source: org_study_id