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

NCT ID: NCT05190562

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-06
• Study Completion Date: 2023-05-30

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Zinc Sulphate

Zinc Sulphate 25 Mg once daily for one month

Group Type: EXPERIMENTAL

Zinc Sulfate 110 MG (Zinc 25 MG) Oral Tablet

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Octozinc

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

mariam hamouda

OTHER

Sponsor Role: lead

Responsible Party

mariam hamouda

The Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Suzan Seif Allah, Professor

Role: STUDY_DIRECTOR

Ain Shams University

Locations

Ain Shams University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FDASU-RECD-111

Identifier Type: -

Identifier Source: org_study_id