ClinicalTrials.gg
CompletedNCT05190562Updated Aug 1, 2023

Effectiveness of Zinc Supplementation in Management of Patients With Symptomatic Benign Migratory Glossitis

A Phase 4 interventional study of Zinc Sulfate 110 MG (Zinc 25 MG) Oral Tablet in Benign Migratory Glossitis, sponsored by mariam hamouda. Completed at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-08-01.

Sponsored by mariam hamouda · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Sep 2021, registered Dec 2021).
Phase
Phase 4
Study type
Interventional
Enrollment
48
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Benign Migratory Glossitis

Keywords

  • Benign Migratory Glossitis
  • Zinc
  • Geographic tongue
03

In context

Glossitis, Benign Migratory

25 studies on the registry are indexed under Glossitis, Benign Migratory; 4 are open to participants now.

This study's enrollment of 48 is below the median of 200 across 13 interventional studies indexed under Glossitis, Benign Migratory.

Browse Glossitis, Benign Migratory studies →

Lead sponsor

This is the only study on the registry with mariam hamouda as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Both genders are eligible.
  2. Adults above 18 years old.
  3. Patients who presented at the control checkup with constant atrophic areas with raised keratotic margins.
  4. Patients who diagnosed with symptomatic geographic tongue.

Exclusion criteria

Exclusion Criteria:

  1. 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).
  2. Psoriatic patients.
  3. Vulnerable patients (Prisoners, persons with mental disabilities or physical handicaps, children, neonates and pregnant women)
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Zinc Sulphate

    Zinc Sulphate 25 Mg once daily for one month

    Drug: Zinc Sulfate 110 MG (Zinc 25 MG) Oral Tablet

Interventions

  • 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

    Also known as: Octozinc

06

What researchers measure

Primary outcomes

  1. Clinical Score

    the size of atrophic areas

    Time frame: change from baseline at 8 weeks

  2. Subjective Scale

    intensity of symptoms

    Time frame: change from baseline at 8 weeks

Secondary outcomes

  1. Biochemical

    salivary zinc levels

    Time frame: change from baseline at 4 weeks

07

Study locations

1 site
  • Ain Shams University
    Cairo, 12345, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2021 to primary completion in Jan 2022, 4 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 31, 2021
First posted
Jan 13, 2022
StartActual
Sep 6, 2021
Primary completionActual
Jan 30, 2022
CompletionActual
May 30, 2023
Last update
Aug 1, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05190562
Lead sponsor
mariam hamouda
Responsible party
mariam hamouda (The Principal Investigator, Ain Shams University) — Sponsor-investigator
First posted
Jan 13, 2022
Start date
Sep 6, 2021
Primary completion
Jan 30, 2022
Completion
May 30, 2023
Last update
Aug 1, 2023

Study contacts

Suzan Seif Allah, Professor
study director · Ain Shams University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Zinc Sulfate

Start the discussion