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: 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.

Study Overview

• Status: Completed
• Conditions: Benign Migratory Glossitis
• Intervention / Treatment: Drug: Zinc Sulfate 110 MG (Zinc 25 MG) Oral Tablet

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12345
    • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult)
• Accepts Healthy Volunteers: No

Description

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:

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Zinc Sulphate; Zinc Sulphate 25 Mg once daily for one month	Drug: Zinc Sulfate 110 MG (Zinc 25 MG) Oral Tablet; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemical	salivary zinc levels	change from baseline at 4 weeks

Collaborators and Investigators

• Sponsor: mariam hamouda
• Investigators: Study Director: Suzan Seif Allah, Professor, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2021
• Primary Completion (Actual): January 30, 2022
• Study Completion (Actual): May 30, 2023

Study Registration Dates

• First Submitted: December 31, 2021
• First Submitted That Met QC Criteria: December 31, 2021
• First Posted (Actual): January 13, 2022

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 29, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Zinc; Benign Migratory Glossitis; Geographic tongue
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tongue Diseases; Glossitis, Benign Migratory; Glossitis; Physiological Effects of Drugs; Dermatologic Agents; Astringents; Zinc Sulfate
• Other Study ID Numbers: FDASU-RECD-111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No