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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06952218
Enrollment
34
Registered
2025-04-30
Start date
2025-12-01
Completion date
2025-12-01
Last updated
2025-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gummy Smile Due to Hypermobile Upper Lip

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.

Interventions

PROCEDUREInjection of cross linked hyaluronic acid filler

Injection of cross linked hyaluronic acid filler

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Gingival displayweek 2, month 1, month 3, month 6, month 9will 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).

Secondary

MeasureTime frameDescription
Patient satisfactionweek 2, month 1, month 3, month 6, month 9The patient will be asked to rate the satisfaction about her/his smile on a scale from 1 to 5 where 1 represents the least satisfied and 5 indicates the most (Makkeiah, Harfoush et al. 2021).
Postoperative painweek 2, month 1, month 3, month 6, month 9The patient will be asked to mark her/his current level of pain on a scale of 10 cm line denoting a range between zero being (no pain) to 10 (maximum pain) (Diaspro, Cavallini et al. 2018).
Lip mobilityweek 2, month 1, month 3, month 6, month 9will be measured by subtracting upper lip length during smiling from upper lip length at rest (Sabbah 2022). The upper lip length is measured from the subnasale to the lower border of the upper lip at the central incisors' region at smile and rest (Ali, Kilani et al. 2023).

Countries

Egypt

Contacts

Primary ContactRaghda Hussein
raghda.metwaly@dentistry.cu.edu.eg01122642622

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026