Excessive Gingival DisplayNCT06577285
The Effect Of Botox In Patients With Gummy Smile With And Without Zinc And Phytase Supplementation.
A study testing zinc gluconate 50 mg with phytase supplement 176mg (800FTU) and zinc gluconate 50 mg in people with Excessive Gingival Display, run by Cairo University at 1 site in Egypt.
Trial summary
Participants with esthetic concern of excessive gingival display who meets the inclusion criteria, will be carried out including history taking, clinical examination and initial therapy. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Excessive Gingival Display
- What is being tested?
- zinc gluconate 50 mg with phytase supplement 176mg (800FTU) and zinc gluconate 50 mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 1 Jun 2025
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with excessive gingival display >3mm and with normal clinical crown dimensions.
- Adults >18 years.
- Non-smokers.
- Systemically healthy.
- Hypermobile lip and mild VME.
Who cannot join
- Severe VME.
- Pregnant or lactating females.
- Patients with inflamed gingiva or gingival enlargement.
- Inflammation or infection at the site of injection.
- Patients with known allergy to any of the components of BTX-A or BTX-B (i.e. BTX, human albumin, saline, lactose and sodium succinate).
- Patients using anticholinesterase or other agents interfering with neuromuscular transmission.
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- Psychologically unstable or who have questionable motives and unrealistic expectations.
- Dependent on intact facial movements and expressions for their livelihood (e.g. actors, singers, musicians and other media personalities).
- Afflicted with a neuromuscular disorder (e.g. myasthenia gravis, Eaton- Lambert syndrome).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect Of Botulinum Toxin A In Patients With Excessive Gingival Display With And Without Zinc And Phytase Supplementation: A Randomized Clinical Trial
Participants with esthetic concern of excessive gingival display who meets the inclusion criteria, will be carried out including history taking, clinical examination and initial therapy.
The initial therapy will consist of periodontal treatment (phase I therapy) including supragingival scaling, subgingival debridement if needed. The mechanical plaque control instructions for each patient include brushing and interdental cleaning techniques. Patients who have inadequate crown length and width ratio or short clinical crown will receive esthetic crown lengthening procedure to adjust gingival levels before being included in this study.
Read more
Patients in the intervention group I will take zinc gluconate 50 mg 1 per day to increase zinc level with phytase supplement 176mg (800FTU) 2 tablets per day to give the maximum absorption of zinc, both supplements will be given for 4 days before botulinum toxin injections. Patients in the intervention group II will take zinc gluconate 50 mg 1 per day to increase zinc level, 4 days before botulinum toxin injections.
Patients in the control group will receive the Botulinum toxin injections only Clinical photographs will be taken at baseline, 2 weeks, 1 month, 3 months postoperatively.
Read the detailed description
Initial examination:
Participants with esthetic concern of excessive gingival display who meets the inclusion criteria, will be carried out including history taking, clinical examination and initial therapy.
The initial therapy will consist of periodontal treatment (phase I therapy) including supragingival scaling, subgingival debridement if needed. The mechanical plaque control instructions for each patient include brushing and interdental cleaning techniques.
Preoperative procedures:
Patients who have inadequate crown length and width ratio or short clinical crown will receive esthetic crown lengthening procedure to adjust gingival levels before being included in this study.
Clinical photographs:
Clinical photographs will be taken at baseline, 2 weeks, 1 month, 3 months postoperatively.
Intervention group I:
Patients in the intervention group I will take zinc gluconate 50 mg (Now food company) 1 per day to increase zinc level with phytase supplement 176mg (800FTU) (Goodphyte company) 2 tablets per day to give the maximum absorption of zinc, both supplements will be given for 4 days before botulinum toxin injections.
Intervention group II:
Patients in the intervention group II will take zinc gluconate 50 mg (Now food company) 1 per day to increase zinc level, 4 days before botulinum toxin injections.
Control group:
Patients in the control group will receive the Botulinum toxin injections only.
Botulinum toxin type A injection:
The patients will be injected at both sides into the "Yonsei point," (3Units) the point that would target 3 muscles responsible for upper lip elevation during smiling, including the levator labii superioris alaeque nasi (LLSAN), in a single injection. This landmark will be identified as the center of a triangle formed by the convergence of the LLSAN, the levator labii superioris (LLS), and the Zygomaticus minor muscles and is located 1 cm lateral to the ala horizontally and 3 cm above the lip line vertically in both men and women (Hwang et al. 2009) and (Nasr et al. 2015).
Postoperative care:
After Botox injection the patients will be instructed to:
- Remain upright for 4 hours after injection (patients may lie in a reclined position, but not lay flat)
- Refrain from aerobic exercise that increases the heart rate.
- Not to massage or manipulate injected areas for 24 hours after injections,
- Refrain from using ibuprofen, for 24 hours following injection.
- If bruising appears, apply ice to area for 15 minutes every hour to decrease bruising.
Follow up:
Botox will gradually take effect over 7-10 days with optimum result at 2 weeks. After 2 weeks the patients would come for an additional touch up dose (1 unit at each injection point)
- Conditions
- Excessive Gingival Display
- Being tested
- zinc gluconate 50 mg with phytase supplement 176mg (800FTU), zinc gluconate 50 mg
- Keywords
- Botulinum Toxin A, Excessive Gingival Display, Zinc And Phytase Supplementation, Botox Injection, Gummy Smile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zinc gluconate 50 mg with phytase supplement 176mg (800FTU)Dietary supplement
zinc gluconate 50 mg1 per day with phytase supplement 176mg (800FTU) (Goodphyte company) 2 tablets per day
zinc gluconate 50 mgDietary supplement
zinc gluconate 50 mg 1 per day, 4 days before botulinum toxin injections.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group I | Active comparator | Patients in the intervention group I will take zinc gluconate 50 mg (Now food company) 1 per day to increase zinc level with phytase supplement 176mg (800FTU) (Goodphyte company) 2 tablets per day to give the maximum absorption of zinc, both supplements will be given for 4 days before botulinum toxin injections. Receives: Dietary Supplement: zinc gluconate 50 mg with phytase supplement 176mg (800FTU) |
| Intervention group II | Active comparator | Patients in the intervention group II will take zinc gluconate 50 mg (Now food company) 1 per day to increase zinc level, 4 days before botulinum toxin injections. Receives: Dietary Supplement: zinc gluconate 50 mg |
| Control group | No intervention | Patients in the control group will receive the Botulinum toxin injections only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival display
To measure the amount of gingival display, a digital camera will be used to take the close up perioral as well as frontal smiling photographs. Care will be taken to capture a nonposed spontaneous smile. A measuring scale with ruler will be used for standardization of the photographs.
Measured: The gingival display will be measured at baseline, 2 weeks, 4 weeks, 2 months, 3 months.
Secondary outcomes (4)
Patient satisfaction (smile self-assessment)
Will be measured by using questionnaire using Likert scale
- Very dissatisfied
- Dissatisfied
- Neutral
- Satisfied
- Very satisfied
Measured: 2 weeks, 3 months
Electrical activity of the smile muscles (EMG)
The compound muscle action potential is an electromyography investigation that measures the simultaneous action potentials for a group of muscle fibers in the same area
Measured: baseline, 2 weeks and 3 months
Smile type
Classification by (Rubin 1974) according to neuromuscular smile pattern
Three main types:
The commissure smile: Mona Lisa smile, where the corners of the mouth are pulled up and outward followed by the levators of the upper lips contracting to show the upper teeth.
The cuspid (canine) smile: The levator labii superioris are dominant. They contract first, exposing the canine teeth. The corners of the mouth contract secondarily to pull the lips upward and outward.
The complex smile: all the elevators of the lips, the elevators of the corners of the mouth, and the depressors of the lower lips contract at the same time to show all the upper and lower teeth
Measured: baseline, 2 weeks and 3 months:
Esthetics (Symmetry) for operators
A group of 12 dentists will evaluate the before and after photographic records and rate the results on a 1 to 5 point scale.
Measured: baseline, 2 weeks and 3 months:
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start1 Jun 2024
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Jun 2025 (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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mawda Mohamed Hussain Eltoum, Cairo University
- Investigators
- Weam A El-Battawy, Ass. Prof., Study director, Cairo UniversityMawda M Hussain, Bachelor, Principal investigator, Cairo UniversityNesma F Shemais, lecturer, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06577285
- Sponsor's protocol ID
- 18514PER3_3_1
- Status last verified
- Sep 2024
- First submitted
- 27 Aug 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Botulinum Toxin A In Patients With Excessive Gingival Display With And Without Zinc And Phytase Supplementation: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06577285
- Acronym / sponsor ID
- 18514PER3_3_1
- Conditions
- Excessive Gingival Display
- Keywords
- Botulinum Toxin A, Excessive Gingival Display, Zinc And Phytase Supplementation, Botox Injection, Gummy Smile
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 29 Aug 2024 (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.
Participants with esthetic concern of excessive gingival display who meets the inclusion criteria, will be carried out including history taking, clinical examination and initial therapy.
The initial therapy will consist of periodontal treatment (phase I therapy) including supragingival scaling, subgingival debridement if needed. The mechanical plaque control instructions for each patient include brushing and interdental cleaning techniques. Patients who have inadequate crown length and width ratio or short clinical crown will receive esthetic crown lengthening procedure to adjust gingival levels before being included in this study.
Patients in the intervention group I will take zinc gluconate 50 mg 1 per day to increase zinc level with phytase supplement 176mg (800FTU) 2 tablets per day to give the maximum absorption of zinc, both supplements will be given for 4 days before botulinum toxin injections. Patients in the intervention group II will take zinc gluconate 50 mg 1 per day to increase zinc level, 4 days before botulinum toxin injections.
Patients in the control group will receive the Botulinum toxin injections only Clinical photographs will be taken at baseline, 2 weeks, 1 month, 3 months postoperatively.
Detailed description
Initial examination:
Participants with esthetic concern of excessive gingival display who meets the inclusion criteria, will be carried out including history taking, clinical examination and initial therapy.
The initial therapy will consist of periodontal treatment (phase I therapy) including supragingival scaling, subgingival debridement if needed. The mechanical plaque control instructions for each patient include brushing and interdental cleaning techniques.
Preoperative procedures:
Patients who have inadequate crown length and width ratio or short clinical crown will receive esthetic crown lengthening procedure to adjust gingival levels before being included in this study.
Clinical photographs:
Clinical photographs will be taken at baseline, 2 weeks, 1 month, 3 months postoperatively.
Intervention group I:
Patients in the intervention group I will take zinc gluconate 50 mg (Now food company) 1 per day to increase zinc level with phytase supplement 176mg (800FTU) (Goodphyte company) 2 tablets per day to give the maximum absorption of zinc, both supplements will be given for 4 days before botulinum toxin injections.
Intervention group II:
Patients in the intervention group II will take zinc gluconate 50 mg (Now food company) 1 per day to increase zinc level, 4 days before botulinum toxin injections.
Control group:
Patients in the control group will receive the Botulinum toxin injections only.
Botulinum toxin type A injection:
The patients will be injected at both sides into the "Yonsei point," (3Units) the point that would target 3 muscles responsible for upper lip elevation during smiling, including the levator labii superioris alaeque nasi (LLSAN), in a single injection. This landmark will be identified as the center of a triangle formed by the convergence of the LLSAN, the levator labii superioris (LLS), and the Zygomaticus minor muscles and is located 1 cm lateral to the ala horizontally and 3 cm above the lip line vertically in both men and women (Hwang et al. 2009) and (Nasr et al. 2015).
Postoperative care:
After Botox injection the patients will be instructed to:
- Remain upright for 4 hours after injection (patients may lie in a reclined position, but not lay flat)
- Refrain from aerobic exercise that increases the heart rate.
- Not to massage or manipulate injected areas for 24 hours after injections,
- Refrain from using ibuprofen, for 24 hours following injection.
- If bruising appears, apply ice to area for 15 minutes every hour to decrease bruising.
Follow up:
Botox will gradually take effect over 7-10 days with optimum result at 2 weeks. After 2 weeks the patients would come for an additional touch up dose (1 unit at each injection point)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention group I | Active comparator | Dietary Supplement: zinc gluconate 50 mg with phytase supplement 176mg (800FTU)Patients in the intervention group I will take zinc gluconate 50 mg (Now food company) 1 per day to increase zinc level with phytase supplement 176mg (800FTU) (Goodphyte company) 2 tablets per day to give the maximum absorption of zinc, both supplements will be given for 4 days before botulinum toxin injections. |
| Intervention group II | Active comparator | Dietary Supplement: zinc gluconate 50 mgPatients in the intervention group II will take zinc gluconate 50 mg (Now food company) 1 per day to increase zinc level, 4 days before botulinum toxin injections. |
| Control group | No intervention | –Patients in the control group will receive the Botulinum toxin injections only. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with excessive gingival display >3mm and with normal clinical crown dimensions.
- Adults >18 years.
- Non-smokers.
- Systemically healthy.
- Hypermobile lip and mild VME.
Key exclusion criteria (9 listed)
- Severe VME.
- Pregnant or lactating females.
- Patients with inflamed gingiva or gingival enlargement.
- Inflammation or infection at the site of injection.
- Patients with known allergy to any of the components of BTX-A or BTX-B (i.e. BTX, human albumin, saline, 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 |
|---|---|---|
| zinc gluconate 50 mg with phytase supplement 176mg (800FTU)zinc gluconate 50 mg1 per day with phytase supplement 176mg (800FTU) (Goodphyte company) 2 tablets per day | Dietary supplement | Intervention group I |
| zinc gluconate 50 mgzinc gluconate 50 mg 1 per day, 4 days before botulinum toxin injections. | Dietary supplement | Intervention group II |
Primary outcome
Gingival display
Time frame: The gingival display will be measured at baseline, 2 weeks, 4 weeks, 2 months, 3 months.
To measure the amount of gingival display, a digital camera will be used to take the close up perioral as well as frontal smiling photographs. Care will be taken to capture a nonposed spontaneous smile. A measuring scale with ruler will be used for standardization of the photographs.
4 secondary outcomes
Patient satisfaction (smile self-assessment)
Time frame: 2 weeks, 3 months
Electrical activity of the smile muscles (EMG)
Time frame: baseline, 2 weeks and 3 months
Smile type
Time frame: baseline, 2 weeks and 3 months:
Esthetics (Symmetry) for operators
Time frame: baseline, 2 weeks and 3 months:
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
Related trials for Excessive Gingival Display
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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.
Weam A El-Battawy, Ass. Prof. study director
Cairo University
Mawda M Hussain, Bachelor principal investigator
Cairo University
Nesma F Shemais, lecturer 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 zinc gluconate 50 mg with phytase supplement 176mg (800FTU) and zinc gluconate 50 mg 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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 23 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mawda M Hussain, Bachelor (+201501005110, mawda.mohamed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival display (time frame: The gingival display will be measured at baseline, 2 weeks, 4 weeks, 2 months, 3 months.). 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 23 Sep 2024; AzTrials last refreshed its copy on 7 Nov 2026.