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

NCT05190562 | Completed Phase 4 DMC

• 1 other identifier: FDASU-RECD-111
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Benign Migratory Glossitis

Keywords

Benign Migratory Glossitis; Zinc; Geographic tongue

Outcome Measures

Primary Outcomes (2)

• Clinical Score

  the size of atrophic areas

  change from baseline at 8 weeks

• Subjective Scale

  intensity of symptoms

  change from baseline at 8 weeks

Secondary Outcomes (1)

• Biochemical

  change from baseline at 4 weeks

Study Arms (1)

Zinc Sulphate

EXPERIMENTAL

Zinc Sulphate 25 Mg once daily for one month

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

Interventions

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

Also known as: Octozinc

Zinc Sulphate

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• mariam hamouda: lead

Study Sites (1)

Ain Shams University

Cairo, 12345, Egypt

Location

MeSH Terms

Conditions

Glossitis, Benign Migratory

Interventions

Zinc Sulfate; Zinc; Tablets

Condition Hierarchy (Ancestors)

Glossitis; Tongue Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Inorganic Chemicals; Zinc Compounds; Metals, Heavy; Elements; Transition Elements; Metals; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Suzan Seif Allah, Professor

  Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The Principal Investigator

Study Record Dates

• First Submitted: December 31, 2021
• First Posted: January 13, 2022
• Study Start: September 6, 2021
• Primary Completion: January 30, 2022
• Study Completion: May 30, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)