Excessive Gingival DisplayNCT07715331
Botulinum Toxin Type A Versus Cross-Linked Hyaluronic Acid Filler Myomodulation for Non-Surgical Management of Excessive Gingival Display
A study testing Botulinum Toxin Type A (Refinex®) and Cross-Linked Hyaluronic Acid Filler (Juvéderm Voluma® with Lidocaine) in people with Excessive Gingival Display and Gingival Diseases, run by Al-Azhar University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Excessive Gingival Display, Gingival Diseases, Gummy Smile
- What is being tested?
- Botulinum Toxin Type A (Refinex®) and Cross-Linked Hyaluronic Acid Filler (Juvéderm Voluma® with Lidocaine)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Excessive gingival display >3 mm during maximal smiling (measured by UNC-15 periodontal probe)
- Age 18-45 years
- Either sex
- Ability to provide written informed consent
- Availability for all follow-up visits at 1, 3, and 6 months post-treatment
Who cannot join
- Chronic neurological diseases or blood coagulation disorders
- Pregnancy or lactation
- Immunological disease or current immunosuppressive drug therapy
- Known sensitivity or allergy to botulinum toxin or hyaluronic acid products
- Previous treatment for gummy smile within 12 months
- Extreme age (outside 18-45 range) or pediatric patients
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dental Medicine for Girls, Al-Azhar University
Cairo, Cairo Governorate
About this study
Official title: A Prospective Randomized Controlled Clinical Trial Evaluating the Efficiency and Patient Satisfaction of Botulinum Toxin Type A Versus Cross-Linked Hyaluronic Acid Filler in the Management of Excessive Gingival Display
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.
Read the detailed description
Study Design: Prospective, two-arm, parallel-group randomized controlled clinical trial. Setting: Oral Diagnosis Clinic, Faculty of Dentistry, Al-Azhar University, Cairo, Egypt. Ethics: Approved by the Research Ethics Committee, Faculty of Dental Medicine for Girls, Al-Azhar University (Code: P-ME-25-02). All participants provided written informed consent. Study conducted in accordance with the Declaration of Helsinki. Randomization: Performed using the National Cancer Institute Clinical Trial Randomization Tool (https://ctrandomization.cancer.gov/), Maximal procedure, Maximum Tolerated Imbalance = 3, allocation ratio 1:1. Group A - BTX-A: Refinex (botulinum toxin type A), 5 IU per side, bilateral injection at the Yonsei point (convergence of levator labii superioris alaeque nasi, levator labii superioris, and zygomaticus minor muscles), single session, 30-gauge needle. Group B - HA Myomodulation: Juvederm Voluma with lidocaine (20 mg/mL cross-linked hyaluronic acid, VYCROSS technology), total 1.0 mL per patient, six periosteal deposits of 0.2 mL each at the piriform fossa bilaterally, anterior nasal spine, and nasal base bilaterally, 27-gauge needle. Negative aspiration confirmed before each injection. Outcome Measurement: Maximum gingival display measured by UNC-15 periodontal probe (three consecutive measurements averaged) at baseline (T0), 1 month (T1), 3 months (T2), and 6 months (T3). Patient satisfaction by Visual Analog Scale (0-10 cm) for overall smile and gingival display satisfaction. Psychosocial impact by 12-item Likert questionnaire. Adverse event monitoring at all follow-up visits. Standardized digital photography at each time point (Nikon D5600, 105mm macro lens). Statistics: SPSS v26.0. Independent-samples t-test for between-group comparisons. Paired-samples t-test for within-group comparisons. Chi-square and Fisher exact tests for categorical data. Pearson correlation for associations between gingival display reduction and satisfaction. Significance at p less than 0.05.
- Being tested
- Botulinum Toxin Type A (Refinex®), Cross-Linked Hyaluronic Acid Filler (Juvéderm Voluma® with Lidocaine)
- Medical subject headings
- Gingival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin Type A (Refinex®)Drug
5 International Units per side, bilateral injection at Yonsei point, single-session treatment
Cross-Linked Hyaluronic Acid Filler (Juvéderm Voluma® with Lidocaine)Drug
20 mg/mL cross-linked HA, total 1.0 mL per patient, five periosteal injection sites; VYCROSS technology
| Study group | Role | What they receive |
|---|---|---|
| BTX-A Group | Active comparator | Participants received bilateral injections of botulinum toxin type A (Refinex®; 5 IU per side) at the Yonsei point - the anatomical convergence of the levator labii superioris alaeque nasi (LLSAN), levator labii superioris (LLS), and zygomaticus minor muscles - using an insulin syringe with a 30-gauge needle. Total dose: 10 IU. Receives: Drug: Botulinum Toxin Type A (Refinex®) |
| HA Myomodulation Group | Active comparator | Participants received cross-linked hyaluronic acid filler (Juvéderm Voluma® with lidocaine; 20 mg/mL; VYCROSS technology) administered as five periosteal deposits of 0.2 mL each (total 1.0 mL) at: piriform fossa and anterior nasal spine bilaterally, and base of nose, using a 27-gauge needle. Negative aspiration confirmed before each injection. Receives: Drug: Cross-Linked Hyaluronic Acid Filler (Juvéderm Voluma® with Lidocaine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Gingival Display
Maximum gingival display (mm) measured from the lower border of the upper lip to the free gingival margin at the right central incisor during standardised maximal smiling, using a UNC-15 periodontal probe. Three consecutive measurements taken and averaged by the same operator.
Measured: Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3) post-treatment
Secondary outcomes (4)
Overall Smile Satisfaction
Patient-reported overall smile satisfaction on a 100-mm Visual Analog Scale (0=completely dissatisfied, 10=completely satisfied)
Measured: Baseline (T0) and 6 months (T3) post-treatment
Gingival Display Satisfaction
Patient-reported gingival display satisfaction scored on a 100-mm Visual Analog Scale (0 = completely dissatisfied, 10 = completely satisfied)
Measured: Baseline (T0) and 6 months (T3) post-treatment
Psychosocial Impact and Treatment Satisfaction
12-item Likert-scale questionnaire assessing aesthetic self-perception, social smiling behaviour, and treatment endorsement including willingness to repeat and recommend the procedure
Measured: Baseline (T0) and 6 months (T3) post-treatment
Adverse Events
Monitoring for injection-site reactions, lip asymmetry, bruising, swelling, or other treatment-related adverse events at all follow-up visits
Measured: 1 month (T1), 3 months (T2), and 6 months (T3) post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start1 Jan 2025
- Primary completion28 Feb 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Excessive Gingival DisplayStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Mahmoud Al-Aboud, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715331
- Sponsor's protocol ID
- P-ME-25-02
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Clinical Trial Evaluating the Efficiency and Patient Satisfaction of Botulinum Toxin Type A Versus Cross-Linked Hyaluronic Acid Filler in the Management of Excessive Gingival Display
- ClinicalTrials.gov ID
- NCT07715331
- Acronym / sponsor ID
- P-ME-25-02
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Design: Prospective, two-arm, parallel-group randomized controlled clinical trial. Setting: Oral Diagnosis Clinic, Faculty of Dentistry, Al-Azhar University, Cairo, Egypt. Ethics: Approved by the Research Ethics Committee, Faculty of Dental Medicine for Girls, Al-Azhar University (Code: P-ME-25-02). All participants provided written informed consent. Study conducted in accordance with the Declaration of Helsinki. Randomization: Performed using the National Cancer Institute Clinical Trial Randomization Tool (https://ctrandomization.cancer.gov/), Maximal procedure, Maximum Tolerated Imbalance = 3, allocation ratio 1:1. Group A - BTX-A: Refinex (botulinum toxin type A), 5 IU per side, bilateral injection at the Yonsei point (convergence of levator labii superioris alaeque nasi, levator labii superioris, and zygomaticus minor muscles), single session, 30-gauge needle. Group B - HA Myomodulation: Juvederm Voluma with lidocaine (20 mg/mL cross-linked hyaluronic acid, VYCROSS technology), total 1.0 mL per patient, six periosteal deposits of 0.2 mL each at the piriform fossa bilaterally, anterior nasal spine, and nasal base bilaterally, 27-gauge needle. Negative aspiration confirmed before each injection. Outcome Measurement: Maximum gingival display measured by UNC-15 periodontal probe (three consecutive measurements averaged) at baseline (T0), 1 month (T1), 3 months (T2), and 6 months (T3). Patient satisfaction by Visual Analog Scale (0-10 cm) for overall smile and gingival display satisfaction. Psychosocial impact by 12-item Likert questionnaire. Adverse event monitoring at all follow-up visits. Standardized digital photography at each time point (Nikon D5600, 105mm macro lens). Statistics: SPSS v26.0. Independent-samples t-test for between-group comparisons. Paired-samples t-test for within-group comparisons. Chi-square and Fisher exact tests for categorical data. Pearson correlation for associations between gingival display reduction and satisfaction. Significance at p less than 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BTX-A Group | Active comparator | Drug: Botulinum Toxin Type A (Refinex®)Participants received bilateral injections of botulinum toxin type A (Refinex®; 5 IU per side) at the Yonsei point - the anatomical convergence of the levator labii superioris alaeque nasi (LLSAN), levator labii superioris (LLS), and zygomaticus minor muscles - using an insulin syringe with a 30-gauge needle. Total dose: 10 IU. |
| HA Myomodulation Group | Active comparator | Drug: Cross-Linked Hyaluronic Acid Filler (Juvéderm Voluma® with Lidocaine)Participants received cross-linked hyaluronic acid filler (Juvéderm Voluma® with lidocaine; 20 mg/mL; VYCROSS technology) administered as five periosteal deposits of 0.2 mL each (total 1.0 mL) at: piriform fossa and anterior nasal spine bilaterally, and base of nose, using a 27-gauge needle. Negative aspiration confirmed before each injection. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Excessive gingival display >3 mm during maximal smiling (measured by UNC-15 periodontal probe)
- Age 18-45 years
- Either sex
- Ability to provide written informed consent
- Availability for all follow-up visits at 1, 3, and 6 months post-treatment
Key exclusion criteria (6 listed)
- Chronic neurological diseases or blood coagulation disorders
- Pregnancy or lactation
- Immunological disease or current immunosuppressive drug therapy
- Known sensitivity or allergy to botulinum toxin or hyaluronic acid products
- Previous treatment for gummy smile within 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Toxin Type A (Refinex®)5 International Units per side, bilateral injection at Yonsei point, single-session treatment | Drug | BTX-A Group |
| 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 | Drug | HA Myomodulation Group |
Primary outcome
Maximum Gingival Display
Time frame: Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3) post-treatment
Maximum gingival display (mm) measured from the lower border of the upper lip to the free gingival margin at the right central incisor during standardised maximal smiling, using a UNC-15 periodontal probe. Three consecutive measurements taken and averaged by the same operator.
4 secondary outcomes
Overall Smile Satisfaction
Time frame: Baseline (T0) and 6 months (T3) post-treatment
Gingival Display Satisfaction
Time frame: Baseline (T0) and 6 months (T3) post-treatment
Psychosocial Impact and Treatment Satisfaction
Time frame: Baseline (T0) and 6 months (T3) post-treatment
Adverse Events
Time frame: 1 month (T1), 3 months (T2), and 6 months (T3) post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum Toxin Type A (Refinex®) and Cross-Linked Hyaluronic Acid Filler (Juvéderm Voluma® with Lidocaine) in people with Excessive Gingival Display and Gingival Diseases, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Gingival Display (time frame: Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3) post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.