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Botulinum Toxin Type A Versus Cross-Linked Hyaluronic Acid Filler Myomodulation for Non-Surgical Management of Excessive Gingival Display

NCT07715331 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-07-21

No results posted yet for this study

Summary

This randomized controlled trial compared the clinical efficacy and patient satisfaction of two non-surgical treatments for excessive gingival display (gummy smile): botulinum toxin type A (BTX-A) and cross-linked hyaluronic acid (HA) filler myomodulation. Excessive gingival display is defined as exposure of 3 mm or more of gingival tissue during maximal smiling. It affects approximately 14% of women and 7% of men and is associated with reduced self-confidence, smile suppression in social settings, and impaired quality of life. When caused by hyperactivity of the upper lip elevator muscles, it can be treated without surgery using injectable therapies. Twenty patients (18 females, 2 males; age 18-45 years) with excessive gingival display greater than 3 mm were randomly allocated 1:1 to one of two groups. Group A (n=10) received bilateral injections of botulinum toxin type A (Refinex; 5 IU per side) at the Yonsei point. Group B (n=10) received cross-linked hyaluronic acid filler (Juvederm Voluma with lidocaine; 1.0 mL total) injected at six periosteal sites around the nose and upper lip using a myomodulation technique. Participants were assessed at baseline and at 1, 3, and 6 months after treatment. The primary outcome was maximum gingival display measured in millimeters using a calibrated periodontal probe. Secondary outcomes included patient satisfaction measured by Visual Analog Scale and a 12-item questionnaire, and adverse event monitoring. Both treatments produced equivalent gingival display reductions at one month (BTX-A: 69.6%; HA: 63.0%). At six months, the HA group maintained a statistically significant 26.4% improvement while the BTX-A group showed near-complete relapse. Despite this, BTX-A patients reported higher categorical satisfaction. Both treatments had excellent safety profiles.

Conditions

  • Excessive Gingival Display
  • Gingival Diseases
  • Gummy Smile
  • Esthetics, Dental

Interventions

DRUG

Botulinum Toxin Type A (Refinex®)

5 International Units per side, bilateral injection at Yonsei point, single-session treatment

DRUG

Cross-Linked Hyaluronic Acid Filler (Juvéderm Voluma® with Lidocaine)

20 mg/mL cross-linked HA, total 1.0 mL per patient, five periosteal injection sites; VYCROSS technology

Sponsors & Collaborators

  • Al-Azhar University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2026-02-28
Completion
2026-02-28

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07715331 on ClinicalTrials.gov