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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05190562
Recruitment Status : Active, not recruiting
First Posted : January 13, 2022
Last Update Posted : May 17, 2022
Sponsor:
Information provided by (Responsible Party):
mariam hamouda, Ain Shams University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Benign Migratory Glossitis Drug: Zinc Sulfate 110 MG (Zinc 25 MG) Oral Tablet Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Zinc Supplementation in Management of Patients With Symptomatic Benign Migratory Glossitis: A Randomized Control Clinical and Biochemical Study
Actual Study Start Date : September 6, 2021
Estimated Primary Completion Date : January 30, 2023
Estimated Study Completion Date : May 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Octozinc


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Biochemical [ Time Frame: change from baseline at 4 weeks ]
    salivary zinc levels


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05190562


Locations
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Egypt
Ain Shams University
Cairo, Egypt, 12345
Sponsors and Collaborators
mariam hamouda
Investigators
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Study Director: Suzan Seif Allah, Professor Ain Shams University
More Information
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Responsible Party: mariam hamouda, The Principal Investigator, Ain Shams University
ClinicalTrials.gov Identifier: NCT05190562    
Other Study ID Numbers: FDASU-RECD-111
First Posted: January 13, 2022    Key Record Dates
Last Update Posted: May 17, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by mariam hamouda, Ain Shams University:
Benign Migratory Glossitis
Zinc
Geographic tongue
Additional relevant MeSH terms:
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Glossitis
Glossitis, Benign Migratory
Tongue Diseases
Mouth Diseases
Stomatognathic Diseases
 Zinc Sulfate
Physiological Effects of Drugs
Astringents
Dermatologic Agents