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NCT Number: NCT06952218

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

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.

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Key information

Conditions

Gummy Smile Due to Hypermobile Upper Lip

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CairoU, Cairo, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Injection of cross linked hyaluronic acid filler

Procedure

Injection of cross linked hyaluronic acid filler

Primary outcomes

  1. Gingival display

    Time frame: week 2, month 1, month 3, month 6, month 9

    will 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 outcomes

  1. Patient satisfaction

    Time frame: week 2, month 1, month 3, month 6, month 9

    The 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).

  2. Postoperative pain

    Time frame: week 2, month 1, month 3, month 6, month 9

    The 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).

  3. Lip mobility

    Time frame: week 2, month 1, month 3, month 6, month 9

    will 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Raghda Hussein

CONTACT

[email protected]

01122642622

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 30, 2025
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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