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Therapeutic Effect of Folic Acid in Healing of Oral Ulcers

Primary Purpose

Oral Ulcer

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Folic Acid 5 MG
placebo
Sponsored by
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Ulcer focused on measuring folic acid, oral ulcers, topical therapy

Eligibility Criteria

14 Years - 44 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • • Age of the participant will be between 14 to 44 years old

    • Both of the genders will be included
    • Patients with oral ulceration

Exclusion Criteria:

  • • Reluctant to participate

    • Non healing ulcerations, lasting for more than 14 days after removing the cause
    • Patients with neurological problems, psoriasis, rheumatoid arthritis.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    intervention group or case group

    control group

    Arm Description

    topical folic acid on oral ulcers will be applied for 7 days and patients will be asked to visit after 7 days for follow up

    placebo drug for oral ulcers

    Outcomes

    Primary Outcome Measures

    healing of ulcers
    patients will be examined to evaluate if the ulcers are healed completely, follow up questionnaire form will be filled by the examining dentist, describing the condition of the patient.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 7, 2021
    Last Updated
    March 23, 2022
    Sponsor
    Dow University of Health Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04989049
    Brief Title
    Therapeutic Effect of Folic Acid in Healing of Oral Ulcers
    Official Title
    Main Objective While Treating the Ulcers is to Reduce the Discomfort and Accelerate Healing. Thus the Purpose of the Study is to Find Out Therapeutic Role of Topical Folic Acid on Oral Ulcerations
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2022 (Anticipated)
    Primary Completion Date
    November 2022 (Anticipated)
    Study Completion Date
    December 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Dow University of Health Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    patients reporting at the department of oral medicine with the complain of oral ulceration will be asked to participate in this study.
    Detailed Description
    Oral ulcerations are usually reported with pain and discomfort while eating and drinking at times while talking. Ulcers are usually described as erythematous surroundings, raised margins, with yellowish-white necrotic pseudomembranous centre. Healing process of ulcers usually starts nearly after 24-48 h of its onset. The initial inflammatory stage is enriched by leukocytes, after 48 hours of injury, mature monocytes in connective tissue turn into macrophages which until day 3 tend to increase in numbers. Oral ulcers are one of the commonest lesions of oral cavity; around 83.6% people have suffered from the ulcers. Frequency of traumatic ulcers fluctuates from 3 to 34% around the globe. Traumatic ulcers are usually caused by mechanical irritaation. Various studies have been conducted till date for the treatment of oral ulcers such as anti-inflammatory gels, propolis extract gel, topical steroids such as triamcinolone acetonide paste and silver nanoparticle gel. Folic acid (vitamin b9) belongs to the water soluble class of vitamins called B-complex. It is an essential component of metabolic pathways of carbohydrates, fats and proteins which are important compounds in various functions such as cardiovascular and nervous system. This vitamin is also important for DNA methylation and biosynthesis of nucleotide. Dietary foliate deficiency is a problem of developing country. Folic acid daily requirement of an adult is 400 mg/day whereas during pregnancy it's required up to 600mg and in nursing mother daily required dosage of foliate is 500mg/day. The difference between folic acid and foliate is that the foliate is a natural form which is found in mushrooms, green leafy vegetables and livers whereas folic acid is synthetically produced and is used to fortify processed foods and supplements in a fully reduced biologically active form dihydrofolate reductase. Humans lack the enzyme which is required to produce foliate that is why they depend on dietary and supplemental form of this essential vitamin. Main objective while treating the ulcers is to reduce the discomfort and accelerate healing. Thus the purpose of the study is to find out therapeutic role of topical folic acid on oral ulcerations. Patients falling in the inclusion criteria will be asked to participate in the study, consent will be obtained from the patients. Demographic feature, history and examination will be noted on a research questionnaire. After examination patients will be given topical folic acid in tablet form to be applied by themselves twice a day on ulcers. Patients will be asked to visit the dental out patients department of oral medicine at Isra University Hyderabad on 7th day for follow up. Specific questions will be asked from the patients and examination will be done on the day of follow, the information will be recorded on a follow up form.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Oral Ulcer
    Keywords
    folic acid, oral ulcers, topical therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Model Description
    75 patients divided into two groups 35 in each
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    75 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    intervention group or case group
    Arm Type
    Active Comparator
    Arm Description
    topical folic acid on oral ulcers will be applied for 7 days and patients will be asked to visit after 7 days for follow up
    Arm Title
    control group
    Arm Type
    Placebo Comparator
    Arm Description
    placebo drug for oral ulcers
    Intervention Type
    Drug
    Intervention Name(s)
    Folic Acid 5 MG
    Other Intervention Name(s)
    folacin
    Intervention Description
    folic acid tablet of 5mg will be placed on the ulcers 2 times per day for 7 days
    Intervention Type
    Other
    Intervention Name(s)
    placebo
    Other Intervention Name(s)
    inactive drug
    Intervention Description
    an inactive drug looking exactly like active drug will be given, patients will be asked to put it on ulcers 2 times per day
    Primary Outcome Measure Information:
    Title
    healing of ulcers
    Description
    patients will be examined to evaluate if the ulcers are healed completely, follow up questionnaire form will be filled by the examining dentist, describing the condition of the patient.
    Time Frame
    7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Maximum Age & Unit of Time
    44 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: • Age of the participant will be between 14 to 44 years old Both of the genders will be included Patients with oral ulceration Exclusion Criteria: • Reluctant to participate Non healing ulcerations, lasting for more than 14 days after removing the cause Patients with neurological problems, psoriasis, rheumatoid arthritis.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tahseen S Khooharo, MSc oral medicine
    Phone
    +923362533399
    Email
    tahseen_shabbir@hotmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Therapeutic Effect of Folic Acid in Healing of Oral Ulcers

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