Benign Migratory GlossitisPhase 4NCT05190562
Effectiveness of Zinc Supplementation in Management of Patients With Symptomatic Benign Migratory Glossitis
A Phase 4 study testing Zinc Sulfate 110 MG (Zinc 25 MG) Oral Tablet in people with Benign Migratory Glossitis, run by mariam hamouda at 1 site in Egypt.
Trial summary
Effectiveness of Zinc Supplementation in management of patients with symptomatic Benign Migratory Glossitis. Zinc supplements seems to be a therapeutic option as Migratory glossitis is a chronic disease knowing that it needs no treatment. Zinc deficiency can probably be a causative factor in filiform papillae atrophy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Benign Migratory Glossitis
- What is being tested?
- Zinc Sulfate 110 MG (Zinc 25 MG) Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Sep 2021to 30 May 2023
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Both genders are eligible.
- Adults above 18 years old.
- Patients who presented at the control checkup with constant atrophic areas with raised keratotic margins.
- Patients who diagnosed with symptomatic geographic tongue.
Who cannot join
- Patients with anemia, oral candidiasis, and indicators for localized irritations (dental caries, affected teeth, sharp teeth edges, dental calculus, faulty dental fillings, and faulty prosthetic procedures).
- Psoriatic patients.
- Vulnerable patients (Prisoners, persons with mental disabilities or physical handicaps, children, neonates and pregnant women)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Zinc Supplementation in Management of Patients With Symptomatic Benign Migratory Glossitis: A Randomized Control Clinical and Biochemical Study
Effectiveness of Zinc Supplementation in management of patients with symptomatic Benign Migratory Glossitis.
Zinc supplements seems to be a therapeutic option as Migratory glossitis is a chronic disease knowing that it needs no treatment. Zinc deficiency can probably be a causative factor in filiform papillae atrophy. Studies have mentioned the role of zinc in wound healing and maintaining a healthy epithelium, as well as regeneration of filiform papillae. Geographic tongue is a disorder that affects the lingual papillae. It has been shown that zinc sulfate can contribute to the treatment of geographic tongue positively.
Read the detailed description
Forty-eight patients diagnosed with symptomatic benign migratory glossitis will be selected from Oral Medicine, Periodontology and Oral Diagnosis department, Faculty of dentistry, Ain shams university. Research ethical committee will review the protocol and the procedure will be explained to the patients and they will sign an informed consent.
Seven days after the diagnosis and selection of patients with (BMG), the atrophic areas will be determined and the patients will attend a control checkup in order to exclude those with constant changing patterns of the red atrophic areas with raised keratotic margins. Only those patients who presented with constant atrophic areas with keratotic margins at the control checkup will be included during the study evaluation process, then the selected patient according the following inclusion and exclusion criteria will be randomly allocated into two groups. Patients met the eligibility criteria will be randomly assigned for 2 different groups using computer generated allocation concealment. Group I: Will include 24 patients with symptomatic BMG receiving Zinc Supplementation once daily and zinc rich diet for one month. (study group).Group II: Will include 24 patients with symptomatic BMG receiving zinc rich diet only For one month. (control group). Intensity of the discomfort will be monitored by the patients using the Visual Analogue Scale (VAS). Saliva will be collected from all included patients to evaluate zinc levels before treatment and one month after treatment only.
- Conditions
- Benign Migratory Glossitis
- Being tested
- Zinc Sulfate 110 MG (Zinc 25 MG) Oral Tablet
- Keywords
- Benign Migratory Glossitis, Zinc, Geographic tongue
- Medical subject headings
- Glossitis, Benign Migratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc Sulfate 110 MG (Zinc 25 MG) Oral TabletDrug
Also called Octozinc
Zinc sulfate is an inorganic compound. It is used as a dietary supplement to treat zinc deficiency and to prevent the condition in those at high risk
| Study group | Role | What they receive |
|---|---|---|
| Zinc Sulphate | Experimental | Zinc Sulphate 25 Mg once daily for one month Receives: Drug: Zinc Sulfate 110 MG (Zinc 25 MG) Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Score
the size of atrophic areas
Measured: change from baseline at 8 weeks
Subjective Scale
intensity of symptoms
Measured: change from baseline at 8 weeks
Secondary outcomes (1)
Biochemical
salivary zinc levels
Measured: change from baseline at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start6 Sep 2021
- Primary completion30 Jan 2022
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Migratory GlossitisStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- mariam hamouda
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, mariam hamouda, Ain Shams University
- Investigators
- Suzan Seif Allah, Professor, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190562
- Sponsor's protocol ID
- FDASU-RECD-111
- Status last verified
- Jul 2023
- First submitted
- 31 Dec 2021
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Zinc Supplementation in Management of Patients With Symptomatic Benign Migratory Glossitis: A Randomized Control Clinical and Biochemical Study
- ClinicalTrials.gov ID
- NCT05190562
- Acronym / sponsor ID
- FDASU-RECD-111
- Conditions
- Benign Migratory Glossitis
- Keywords
- Benign Migratory Glossitis, Zinc, Geographic tongue
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- mariam hamoudaUniversity, hospital or other
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 13 Jan 2022 (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.
Effectiveness of Zinc Supplementation in management of patients with symptomatic Benign Migratory Glossitis.
Zinc supplements seems to be a therapeutic option as Migratory glossitis is a chronic disease knowing that it needs no treatment. Zinc deficiency can probably be a causative factor in filiform papillae atrophy. Studies have mentioned the role of zinc in wound healing and maintaining a healthy epithelium, as well as regeneration of filiform papillae. Geographic tongue is a disorder that affects the lingual papillae. It has been shown that zinc sulfate can contribute to the treatment of geographic tongue positively.
Detailed description
Forty-eight patients diagnosed with symptomatic benign migratory glossitis will be selected from Oral Medicine, Periodontology and Oral Diagnosis department, Faculty of dentistry, Ain shams university. Research ethical committee will review the protocol and the procedure will be explained to the patients and they will sign an informed consent.
Seven days after the diagnosis and selection of patients with (BMG), the atrophic areas will be determined and the patients will attend a control checkup in order to exclude those with constant changing patterns of the red atrophic areas with raised keratotic margins. Only those patients who presented with constant atrophic areas with keratotic margins at the control checkup will be included during the study evaluation process, then the selected patient according the following inclusion and exclusion criteria will be randomly allocated into two groups. Patients met the eligibility criteria will be randomly assigned for 2 different groups using computer generated allocation concealment. Group I: Will include 24 patients with symptomatic BMG receiving Zinc Supplementation once daily and zinc rich diet for one month. (study group).Group II: Will include 24 patients with symptomatic BMG receiving zinc rich diet only For one month. (control group). Intensity of the discomfort will be monitored by the patients using the Visual Analogue Scale (VAS). Saliva will be collected from all included patients to evaluate zinc levels before treatment and one month after treatment only.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zinc Sulphate | Experimental | Drug: Zinc Sulfate 110 MG (Zinc 25 MG) Oral TabletZinc Sulphate 25 Mg once daily for one month |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Both genders are eligible.
- Adults above 18 years old.
- Patients who presented at the control checkup with constant atrophic areas with raised keratotic margins.
- Patients who diagnosed with symptomatic geographic tongue.
Key exclusion criteria (3 listed)
- Patients with anemia, oral candidiasis, and indicators for localized irritations (dental caries, affected teeth, sharp teeth edges, dental calculus, faulty dental fillings, and faulty prosthetic procedures).
- Psoriatic patients.
- Vulnerable patients (Prisoners, persons with mental disabilities or physical handicaps, children, neonates and pregnant women)
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 Sulfate 110 MG (Zinc 25 MG) Oral TabletAlso: OctozincZinc sulfate is an inorganic compound. It is used as a dietary supplement to treat zinc deficiency and to prevent the condition in those at high risk | Drug | Zinc Sulphate |
Primary outcome
Clinical Score
Time frame: change from baseline at 8 weeks
the size of atrophic areas
Subjective Scale
Time frame: change from baseline at 8 weeks
intensity of symptoms
1 secondary outcome
Biochemical
Time frame: change from baseline at 4 weeks
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 1 Aug 2023.
- 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.
Suzan Seif Allah, Professor study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zinc Sulfate 110 MG (Zinc 25 MG) Oral Tablet in people with Benign Migratory Glossitis, run by mariam hamouda 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: finished, as of the sponsor's last update on 1 Aug 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Clinical Score (time frame: change from baseline at 8 weeks). The study lists 2 primary outcomes in all. 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 1 Aug 2023.