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NCT Number: NCT05190562

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ain Shams University

Cairo, 12345, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)

Treatment and study plan

Zinc Sulfate 110 MG (Zinc 25 MG) Oral Tablet

Drug

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

Other names: Octozinc

Primary outcomes

  1. Clinical Score

    Time frame: change from baseline at 8 weeks

    the size of atrophic areas

  2. Subjective Scale

    Time frame: change from baseline at 8 weeks

    intensity of symptoms

Secondary outcomes

  1. Biochemical

    Time frame: change from baseline at 4 weeks

    salivary zinc levels

Sponsors and collaborators

Lead sponsor

mariam hamouda

Other

Registry information

Official study title

Effectiveness of Zinc Supplementation in Management of Patients With Symptomatic Benign Migratory Glossitis: A Randomized Control Clinical and Biochemical Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jan 13, 2022
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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