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临床试验/NCT05190562
NCT05190562已完成4 期

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

mariam hamouda1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2021年9月6日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
48
试验地点
1
主要终点
Clinical Score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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)

研究组 & 干预措施

Zinc Sulphate

Experimental

Zinc Sulphate 25 Mg once daily for one month

干预措施: Zinc Sulfate 110 MG (Zinc 25 MG) Oral Tablet (Drug)

结局指标

主要结局

Clinical Score

时间窗: change from baseline at 8 weeks

the size of atrophic areas

Subjective Scale

时间窗: change from baseline at 8 weeks

intensity of symptoms

次要结局

  • Biochemical(change from baseline at 4 weeks)

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

mariam hamouda

The Principal Investigator

Ain Shams University

研究点 (1)

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