Clinical trial NCT06952218: Effect of Cross-linked Hyaluronic Acid Filler Versus Botulinum Toxin Type A (Botox) in Management of Gummy Smile
Official title: Effect of Cross-linked Hyaluronic Acid Filler Versus Botulinum Toxin Type A (Botox) in Management of Gummy Smile: Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gummy Smile Due to Hypermobile Upper Lip
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Gingival display
timeFrame: week 2, month 1, month 3, month 6, month 9
Secondary outcomes:
measure: Patient satisfaction
timeFrame: week 2, month 1, month 3, month 6, month 9
measure: Postoperative pain
timeFrame: week 2, month 1, month 3, month 6, month 9
measure: Lip mobility
timeFrame: week 2, month 1, month 3, month 6, month 9
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: CairoU
city: Giza
country: Egypt
facility: Cairo University
Study officials:
References: