MagnesiumNCT07874009
Can Adjunctive Oral Magnesium Supplementation Prolong the Effect of Botulinum Toxin Type A in Excessive Gingival Display?
A study testing Oral Magnesium Glycinate capsules and ● BoNT-A Injection Alone (Day 0) in people with Magnesium and Botulinum Toxin Type A, run by Cairo University at 1 site in Egypt.
Trial summary
To evaluate and compare the effect of adjuvant oral magnesium supplementation combined with Botulinum Toxin Type A versus Botulinum Toxin Type A alone on the reduction of millimeter gingival display and the duration of clinical effectiveness in patients with excessive gingival display Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Magnesium, Botulinum Toxin Type A, Excessive Gingival Display
- What is being tested?
- Oral Magnesium Glycinate capsules and ● BoNT-A Injection Alone (Day 0)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2026to 30 Oct 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged >18 years.
- Presence of neuromuscular Excessive Gingival Display >3mm of gingival exposure from the inferior border of the upper lip to the gingival margin of maxillary central incisors during a maximum spontaneous smile).
- Healthy systemic condition ( American Society of Anesthesiologists Physical Status Classification System Class I).
- Complete maxillary anterior dentition with healthy periodontal tissues
Who cannot join
- 2. Pregnant or lactating females. 3. Patients with inflamed gingiva or gingival enlargement. 4. Inflammation or infection at the site of injection. 5. Patients with known allergy to any of the components of botulinum toxin type A or botulinum toxin type B (i.e. botulinum toxin , human albumin, saline, lactose and sodium succinate).
- 6. Patients using anticholinesterase or other agents interfering with neuromuscular transmission.
- 7. Psychologically unstable or who have questionable motives and unrealistic expectations.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Can Adjunctive Oral Magnesium Supplementation Prolong the Effect of Botulinum Toxin Type A in Patients With Excessive Gingival Display? A Randomized Controlled Clinical Trial
To evaluate and compare the effect of adjuvant oral magnesium supplementation combined with Botulinum Toxin Type A versus Botulinum Toxin Type A alone on the reduction of millimeter gingival display and the duration of clinical effectiveness in patients with excessive gingival display
Read the detailed description
Excessive Gingival Display , commonly termed "gummy smile," is defined as exposing more than 2 to 3 mm of gingiva during a full, unforced smile. It affects up to 10%-29% of young adults, predominantly females, and frequently leads to patient dissatisfaction with smile aesthetics. While Excessive Gingival Display can originate from skeletal vertical maxillary excess or altered passive eruption, a primary etiology is the hyperfunction of the upper lip elevator muscles (primarily Levator Labii Superioris Alaeque Nasi [LLSAN], Levator Labii Superioris [LLS], and Zygomaticus Minor).
The application of Botulinum Toxin Type A (BoNT-A) has become a minimally invasive gold standard for managing muscular Excessive Gingival Display. However, a major clinical drawback remains its transient duration, requiring repeated injections every 3 to 6 months. Frequent re-injections increase economic burden, patient discomfort, and the potential risk of neutralising antibody formation leading to secondary treatment failure. Strategies to optimize the duration and clinical efficacy ofBotulinum Toxin Type A remain a critical gap in periodontal and aesthetic research.
Rationale for conducting the research:
Botulinum Toxin Type A exerts muscle relaxation at the neuromuscular junction by cleaving SNAP-25 proteins, preventing calcium-dependent acetylcholine exocytosis. Extracellular calcium influx into presynaptic motor axon terminals is the compulsory trigger for acetylcholine release. Physiological evidence demonstrates that Magnesium serves as a natural, competitive calcium channel antagonist at presynaptic nerve terminals. Higher local concentrations of magnesium impair presynaptic entry, thereby suppressing neurotransmitter release.
While zinc supplementation has been studied due to Botulinum Toxin Type A nature as a zinc-dependent metalloprotease, magnesium acts downstream directly at the physiological level of the neuromuscular junction. Co-administering oral magnesium during the neurotoxin uptake window may synergistically decrease presynaptic exocytosis, enhancing initial muscular relaxation or extending clinical paralysis. Given the safety and low cost of oral magnesium, demonstrating its additive benefit would significantly improve patient satisfaction, lower annual treatment costs, and refine non-surgical smile line management.
To evaluate and compare the effect of adjuvant oral magnesium supplementation combined with Botulinum Toxin Type A versus Botulinum Toxin Type A alone on the reduction of millimeter gingival display and the duration of clinical effectiveness in patients with excessive gingival display
- Conditions
- Magnesium, Botulinum Toxin Type A, Excessive Gingival Display, Oral
- Being tested
- Oral Magnesium Glycinate capsules, ● BoNT-A Injection Alone (Day 0)
- Keywords
- Excessive Gingival Display, Magnesium Supplementation, Botulinum Toxin Type A, Adjunctive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Magnesium Glycinate capsulesDrug
Oral Supplement: Oral Magnesium Glycinate capsules (300 mg elemental magnesium daily, single or divided dose taken with meals). Supplementation starts 4 weeks prior to BoNT-A injection (Day -28) to achieve intracellular steady-state repletion and continues for 4 weeks post-injection (through Day 28), totaling 8 consecutive weeks (56 days) of daily intake
● BoNT-A Injection Alone (Day 0)Drug
BoNT-A Injection Alone (Day 0): Identical administration protocol (2.5 Units per side bilaterally at the Yonsei Point, total 5.0 Units) delivered by the same experienced operator without any oral supplementation.
| Study group | Role | What they receive |
|---|---|---|
| Oral Supplement group: Oral Magnesium Glycinate capsules | Experimental | Oral Supplement group: Oral Magnesium Glycinate capsules (300 mg elemental magnesium daily, single or divided dose taken with meals). Supplementation starts 4 weeks prior to BoNT-A injection (Day -28) to achieve intracellular steady-state repletion and continues for 4 weeks post-injection (through Day 28), totaling 8 consecutive weeks (56 days) of daily intake. Receives: Drug: Oral Magnesium Glycinate capsules |
| Botulinum toxin type A Injection Alone group | Active comparator | Botulinum toxin type A Injection Alone group: Botulinum toxin type A Injection Alone group : BoNT-A Injection Alone (Day 0): Identical administration protocol (2.5 Units per side bilaterally at the Yonsei Point, total 5.0 Units) delivered by the same experienced operator without any oral supplementation Receives: Drug: ● BoNT-A Injection Alone (Day 0) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gingival display
Change in gingival display BY Ruler in Millimeters
Measured: at 6 weeks
Secondary outcomes (1)
Assessment of Pain by visual analogue scale
The left end represents no pain (0 mm), and the right end represents the worst possible
Measured: at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start1 Oct 2026
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MagnesiumStudies 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
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maie Ismaiel mohammed Fathy, Cairo University
- Investigators
- Maie Esmaiel, lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874009
- Sponsor's protocol ID
- 23564MD
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It will be available if it needed
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Adjunctive Oral Magnesium Supplementation Prolong the Effect of Botulinum Toxin Type A in Patients With Excessive Gingival Display? A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07874009
- Acronym / sponsor ID
- 23564MD
- Conditions
- Magnesium, Botulinum Toxin Type A, Excessive Gingival Display, Oral
- Keywords
- Excessive Gingival Display, Magnesium Supplementation, Botulinum Toxin Type A, Adjunctive
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 14 Oct 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.
To evaluate and compare the effect of adjuvant oral magnesium supplementation combined with Botulinum Toxin Type A versus Botulinum Toxin Type A alone on the reduction of millimeter gingival display and the duration of clinical effectiveness in patients with excessive gingival display
Detailed description
Excessive Gingival Display , commonly termed "gummy smile," is defined as exposing more than 2 to 3 mm of gingiva during a full, unforced smile. It affects up to 10%-29% of young adults, predominantly females, and frequently leads to patient dissatisfaction with smile aesthetics. While Excessive Gingival Display can originate from skeletal vertical maxillary excess or altered passive eruption, a primary etiology is the hyperfunction of the upper lip elevator muscles (primarily Levator Labii Superioris Alaeque Nasi [LLSAN], Levator Labii Superioris [LLS], and Zygomaticus Minor).
The application of Botulinum Toxin Type A (BoNT-A) has become a minimally invasive gold standard for managing muscular Excessive Gingival Display. However, a major clinical drawback remains its transient duration, requiring repeated injections every 3 to 6 months. Frequent re-injections increase economic burden, patient discomfort, and the potential risk of neutralising antibody formation leading to secondary treatment failure. Strategies to optimize the duration and clinical efficacy ofBotulinum Toxin Type A remain a critical gap in periodontal and aesthetic research.
Rationale for conducting the research:
Botulinum Toxin Type A exerts muscle relaxation at the neuromuscular junction by cleaving SNAP-25 proteins, preventing calcium-dependent acetylcholine exocytosis. Extracellular calcium influx into presynaptic motor axon terminals is the compulsory trigger for acetylcholine release. Physiological evidence demonstrates that Magnesium serves as a natural, competitive calcium channel antagonist at presynaptic nerve terminals. Higher local concentrations of magnesium impair presynaptic entry, thereby suppressing neurotransmitter release.
While zinc supplementation has been studied due to Botulinum Toxin Type A nature as a zinc-dependent metalloprotease, magnesium acts downstream directly at the physiological level of the neuromuscular junction. Co-administering oral magnesium during the neurotoxin uptake window may synergistically decrease presynaptic exocytosis, enhancing initial muscular relaxation or extending clinical paralysis. Given the safety and low cost of oral magnesium, demonstrating its additive benefit would significantly improve patient satisfaction, lower annual treatment costs, and refine non-surgical smile line management.
To evaluate and compare the effect of adjuvant oral magnesium supplementation combined with Botulinum Toxin Type A versus Botulinum Toxin Type A alone on the reduction of millimeter gingival display and the duration of clinical effectiveness in patients with excessive gingival display
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Supplement group: Oral Magnesium Glycinate capsules | Experimental | Drug: Oral Magnesium Glycinate capsulesOral Supplement group: Oral Magnesium Glycinate capsules (300 mg elemental magnesium daily, single or divided dose taken with meals). Supplementation starts 4 weeks prior to BoNT-A injection (Day -28) to achieve intracellular steady-state repletion and continues for 4 weeks post-injection (through Day 28), totaling 8 consecutive weeks (56 days) of daily intake. |
| Botulinum toxin type A Injection Alone group | Active comparator | Drug: ● BoNT-A Injection Alone (Day 0)Botulinum toxin type A Injection Alone group: Botulinum toxin type A Injection Alone group : BoNT-A Injection Alone (Day 0): Identical administration protocol (2.5 Units per side bilaterally at the Yonsei Point, total 5.0 Units) delivered by the same experienced operator without any oral supplementation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patients aged >18 years.
- Presence of neuromuscular Excessive Gingival Display >3mm of gingival exposure from the inferior border of the upper lip to the gingival margin of maxillary central incisors during a maximum spontaneous smile).
- Healthy systemic condition ( American Society of Anesthesiologists Physical Status Classification System Class I).
- Complete maxillary anterior dentition with healthy periodontal tissues
Key exclusion criteria (3 listed)
- 2. Pregnant or lactating females. 3. Patients with inflamed gingiva or gingival enlargement. 4. Inflammation or infection at the site of injection. 5. Patients with known allergy to any of the components of botulinum toxin type A or botulinum toxin type B (i.e. botulinum toxin , human albumin, saline, lactose and sodium succinate).
- 6. Patients using anticholinesterase or other agents interfering with neuromuscular transmission.
- 7. Psychologically unstable or who have questionable motives and unrealistic expectations.
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 |
|---|---|---|
| Oral Magnesium Glycinate capsulesOral Supplement: Oral Magnesium Glycinate capsules (300 mg elemental magnesium daily, single or divided dose taken with meals). Supplementation starts 4 weeks prior to BoNT-A injection (Day -28) to achieve intracellular steady-state repletion and continues for 4 weeks post-injection (through Day 28), totaling 8 consecutive weeks (56 days) of daily intake | Drug | Oral Supplement group: Oral Magnesium Glycinate capsules |
| ● BoNT-A Injection Alone (Day 0)BoNT-A Injection Alone (Day 0): Identical administration protocol (2.5 Units per side bilaterally at the Yonsei Point, total 5.0 Units) delivered by the same experienced operator without any oral supplementation. | Drug | Botulinum toxin type A Injection Alone group |
Primary outcome
Change in gingival display
Time frame: at 6 weeks
Change in gingival display BY Ruler in Millimeters
1 secondary outcome
Assessment of Pain by visual analogue scale
Time frame: at 6 weeks
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 14 Oct 2026.
- Individual participant dataSharing planned: Yes. It will be available if it needed
Related trials for Magnesium
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruiting
Alveolar Ridge Reconstruction in Post-extraction Sites Using a Magnesium Resorbable Membrane. An Explorative Study
Bone Augmentation, Alveolar Ridge Augmentation
Not yet recruiting
Biodegradable Magnesium Screws for Unstable Ankle Fracture Surgery
Ankle Fractures, Syndesmotic Injury
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Active, not recruitingObservational study
The Effect of Magnesium on Post-spinal Headaches
Post-spinal Headache
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.
Maie Esmaiel, lecturer principal investigator
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 Oral Magnesium Glycinate capsules and ● BoNT-A Injection Alone (Day 0) in people with Magnesium and Botulinum Toxin Type A, 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 4 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 14 Oct 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?
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?
Change in gingival display (time frame: at 6 weeks). 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 14 Oct 2026.