Excessive Gingival DisplayNCT06075134
EMG-guided Botox Injection Versus Conventional Botox Injection in Gummy Smile Patients
A study testing Botox injection, EMG and Zinc Supplement in people with Excessive Gingival Display, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to compare the effect of EMG-guided Botox injection with conventional Botox injection in Yonsei point, in patients with excessive gingival display. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Excessive Gingival Display
- What is being tested?
- Botox injection, EMG and Zinc Supplement
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2024to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with excessive gingival display.
- Patients with esthetic concerns.
- Patients with mild to moderate VME (vertical maxillary excess).
- Normal clinical crown dimensions.
- Patients aged 18 to 50.
- Systemically healthy patients.
- Non-smokers.
Who cannot join
- Patients with severe VME (vertical maxillary excess).
- Pregnant and breastfeeding women.
- Patients with gingival inflammation and/or enlargement.
- Inflammation or infection at the site of injection.
- Patients with known allergy to any of the components of Botox (i.e., saline, human albumin, lactose and sodium succinate).
- Patients using anticholinesterase or other agents affecting neuromuscular transmission.
- Psychologically unstable patients or those who have unrealistic expectations and questionable motives.
- Patients with neuromuscular disorders (e.g., myasthenia gravis, Eaton-Lambert syndrome).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nesma Shemais, PhD contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Cairo University
Cairo
Sherry Fayez Akhnokh, +2 01284857175, sherry.akhnokh@dentistry.cu.edu.eg
About this study
Official title: EMG-guided Botox Injection Versus Conventional Injection in Yonsei Point in Gummy Smile Patients: A Randomized Clinical Trial
The goal of this clinical trial is to compare the effect of EMG-guided Botox injection with conventional Botox injection in Yonsei point, in patients with excessive gingival display.
The main question it aims to answer is:
Read more
- Does the use of electromyography (EMG) as a guide during Botox injection for patients with gummy smile has better effect than conventional injection in Yonsei point?
Participants will be randomized in equal proportions between intervention and control groups.
- Preoperative assessment of amount of gingival display, lip length (philtrum and vermilion length), and smile type.
- For the intervention group, EMG readings will be done in Clinical Neurophysiology Department, Kasr Al-Ainy Hospital EMG-guided Botox injection (Intervention group). Conventional Botox injection in Yonsei point (Control group).
- Conditions
- Excessive Gingival Display
- Being tested
- Botox injection, EMG, Zinc Supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botox injectionProcedure or surgery
Also called Botulinum toxin injection
Botox injection
EMGDevice
Also called Electromyography
Quantitative Electromyography
Zinc SupplementDrug
Also called Zinc supplement in the form of tablets
To increase efficacy of Botox
| Study group | Role | What they receive |
|---|---|---|
| EMG-guided Botox injection | Experimental | Botox injection in patients with gummy smile will be done under electromyography guidance to target the most hyperactive and effective muscle that is the chief factor causing the condition. Receives: Procedure: Botox injection; Device: EMG; Drug: Zinc Supplement |
| Conventional Botox injection in Yonsei point | Active comparator | Conventional injection of Botox is located in Yonsei point, which is the center of a triangle formed by the convergence of Levator labii superioris alaeque nasi (LLSAN), levator labii superioris (LLS), zygomaticus minor (ZMn), muscles, and is located 1 cm lateral to the ala of the nose horizontally and 3 cm above the lip line vertically. Receives: Procedure: Botox injection; Drug: Zinc Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in amount of gingival display
Will be measured using ruler in mm.
Measured: Baseline, One-week, One-month, three-months, and six-months follow-up
Secondary outcomes (6)
Quantitative EMG
Will be measured using EMG in mv.
Measured: Baseline, One-week and six-months follow-up
Patient satisfaction
Will be assessed using questionnaire, on a scale from 1 to 5, where 1 is completely not satisfied and 5 is completely satisfied.
Measured: Baseline, One-week, One-month, three-months, and six-months follow-up
Post-operative pain
Will be measured using visual analogue scale (VAS) from 1 to 10.
Measured: Baseline, One-week, and One-month follow-up
Smile type
Qualitative, by Rubin (1974). Smile is classified into 1. Corner of the mouth (Mona Lisa) smile, 2. Canine Smile, and 3. Full denture smile
Measured: Baseline, One-week, One-month, three-months, and six-months follow-up
Change in lip length
Will be measured using UNC (University of North Carolina) -15 periodontal probe in mm.
Measured: Baseline, One-week, One-month, three-months, and six-months follow-up
Esthetics (Symmetry) for operators
Will be measured using 5-point Likert scale, where 1 is significantly asymmetrical and 5 is completely symmetrical.
Measured: Baseline, One-week, One-month, three-months, and six-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Nov 2024
- Primary completionJun 2026 (estimated)
- Study completionAug 2026 (estimated)
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 Cairo 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherry Fayez Akhnokh, Cairo University
- Investigators
- Sherry Fayez Akhnokh, BSc, Principal investigator, Cairo UniversityNoha Ghallab, PhD, Study director, Cairo UniversityNesma Shemais, PhD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075134
- Sponsor's protocol ID
- SFAkhnokh
- Status last verified
- Mar 2026
- First submitted
- 26 Sep 2023
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMG-guided Botox Injection Versus Conventional Injection in Yonsei Point in Gummy Smile Patients: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06075134
- Acronym / sponsor ID
- SFAkhnokh
- Conditions
- Excessive Gingival Display
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 10 Oct 2023 (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.
The goal of this clinical trial is to compare the effect of EMG-guided Botox injection with conventional Botox injection in Yonsei point, in patients with excessive gingival display.
The main question it aims to answer is:
- Does the use of electromyography (EMG) as a guide during Botox injection for patients with gummy smile has better effect than conventional injection in Yonsei point?
Participants will be randomized in equal proportions between intervention and control groups.
- Preoperative assessment of amount of gingival display, lip length (philtrum and vermilion length), and smile type.
- For the intervention group, EMG readings will be done in Clinical Neurophysiology Department, Kasr Al-Ainy Hospital EMG-guided Botox injection (Intervention group). Conventional Botox injection in Yonsei point (Control group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMG-guided Botox injection | Experimental | Procedure: Botox injection, Device: EMG, Drug: Zinc SupplementBotox injection in patients with gummy smile will be done under electromyography guidance to target the most hyperactive and effective muscle that is the chief factor causing the condition. |
| Conventional Botox injection in Yonsei point | Active comparator | Procedure: Botox injection, Drug: Zinc SupplementConventional injection of Botox is located in Yonsei point, which is the center of a triangle formed by the convergence of Levator labii superioris alaeque nasi (LLSAN), levator labii superioris (LLS), zygomaticus minor (ZMn), muscles, and is located 1 cm lateral to the ala of the nose horizontally and 3 cm above the lip line vertically. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients with excessive gingival display.
- Patients with esthetic concerns.
- Patients with mild to moderate VME (vertical maxillary excess).
- Normal clinical crown dimensions.
- Patients aged 18 to 50.
Key exclusion criteria (8 listed)
- Patients with severe VME (vertical maxillary excess).
- Pregnant and breastfeeding women.
- Patients with gingival inflammation and/or enlargement.
- Inflammation or infection at the site of injection.
- Patients with known allergy to any of the components of Botox (i.e., saline, human albumin, lactose and sodium succinate).
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 |
|---|---|---|
| Botox injectionAlso: Botulinum toxin injectionBotox injection | Procedure or surgery | Conventional Botox injection in Yonsei point, EMG-guided Botox injection |
| EMGAlso: ElectromyographyQuantitative Electromyography | Device | EMG-guided Botox injection |
| Zinc SupplementAlso: Zinc supplement in the form of tabletsTo increase efficacy of Botox | Drug | Conventional Botox injection in Yonsei point, EMG-guided Botox injection |
Primary outcome
Change in amount of gingival display
Time frame: Baseline, One-week, One-month, three-months, and six-months follow-up
Will be measured using ruler in mm.
6 secondary outcomes
Quantitative EMG
Time frame: Baseline, One-week and six-months follow-up
Patient satisfaction
Time frame: Baseline, One-week, One-month, three-months, and six-months follow-up
Post-operative pain
Time frame: Baseline, One-week, and One-month follow-up
Smile type
Time frame: Baseline, One-week, One-month, three-months, and six-months follow-up
Change in lip length
Time frame: Baseline, One-week, One-month, three-months, and six-months follow-up
Esthetics (Symmetry) for operators
Time frame: Baseline, One-week, One-month, three-months, and six-months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
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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.
Nesma Shemais, PhD contact
Sherry Fayez Akhnokh, BSc principal investigator
Cairo University
Noha Ghallab, PhD study director
Cairo University
Nesma Shemais, PhD study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botox injection, EMG and Zinc Supplement in people with Excessive Gingival Display, run by Cairo 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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 20 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sherry Fayez Akhnokh, BSc (+0201284857175, sherry.akhnokh@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in amount of gingival display (time frame: Baseline, One-week, One-month, three-months, and six-months follow-up). 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 20 Mar 2026.