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

• ClinicalTrials.gov Identifier: NCT05190562
• Recruitment Status: Active, not recruiting
• First Posted: January 13, 2022
• Last Update Posted: May 17, 2022
• Sponsor: mariam hamouda
• Information provided by (Responsible Party): mariam hamouda, Ain Shams University

Tracking Information

• First Submitted Date: December 31, 2021
• First Posted Date: January 13, 2022
• Last Update Posted Date: May 17, 2022
• Actual Study Start Date: September 6, 2021
• Estimated Primary Completion Date: January 30, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 31, 2021)

• Clinical Score [ Time Frame: change from baseline at 8 weeks ]
  the size of atrophic areas
• Subjective Scale [ Time Frame: change from baseline at 8 weeks ]
  intensity of symptoms

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 31, 2021)

Biochemical [ Time Frame: change from baseline at 4 weeks ]

salivary zinc levels

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Benign Migratory Glossitis

Intervention

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 Name: Octozinc

Study Arms

Experimental: Zinc Sulphate

Zinc Sulphate 25 Mg once daily for one month

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: December 31, 2021): 48
• Original Actual Enrollment: Same as current
• Estimated Study Completion Date: May 30, 2023
• Estimated Primary Completion Date: January 30, 2023 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT05190562
• Other Study ID Numbers: FDASU-RECD-111
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: mariam hamouda, Ain Shams University
• Original Responsible Party: mariam hamouda, Ain Shams University, Masters Candidate
• Current Study Sponsor: mariam hamouda
• Original Study Sponsor: Ain Shams University
• Collaborators: Not Provided

Investigators

• Study Director: Suzan Seif Allah, Professor; Ain Shams University

• PRS Account: Ain Shams University
• Verification Date: May 2022