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
About this trial
This is an interventional treatment trial for Oral Ulcer focused on measuring folic acid, oral ulcers, topical therapy
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.
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
NCT ID
NCT04989049
First Posted
July 7, 2021
Last Updated
March 23, 2022
Sponsor
Dow University of Health Sciences
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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