Effect of Cross-linked Hyaluronic Acid Filler Versus Botulinum Toxin Type A (Botox) in Management of Gummy Smile
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Injection of cross linked hyaluronic acid filler.
- Who it may be relevant to
- Registry conditions: Gummy Smile Due to Hypermobile Upper Lip. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Cross-linked Hyaluronic Acid Filler Versus Botulinum Toxin Type A (Botox) in Management of Gummy Smile: Randomized Controlled Clinical Trial
Overview
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.
Interventions
- Procedure Injection of cross linked hyaluronic acid filler
Injection of cross linked hyaluronic acid filler
Primary outcome measures
- Gingival display [Time frame: week 2, month 1, month 3, month 6, month 9]
Secondary outcome measures (3)
- Patient satisfaction [Time frame: week 2, month 1, month 3, month 6, month 9]
- Postoperative pain [Time frame: week 2, month 1, month 3, month 6, month 9]
- Lip mobility [Time frame: week 2, month 1, month 3, month 6, month 9]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Egypt · 2 centers
- CairoU — Cairo
- Cairo University — Giza
Identifiers
NCT: NCT06952218 · 5699269