Therapeutic Effect of Folic Acid in Healing of Oral Ulcers

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 reporting at the department of oral medicine with the complain of oral ulceration will be asked to participate in this study.

Study Overview

• Status: Not yet recruiting
• Conditions: Oral Ulcer
• Intervention / Treatment: Drug: Folic Acid 5 MG; Other: placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Tahseen S Khooharo, MSc oral medicine; Phone Number: +923362533399; Email: tahseen_shabbir@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 44 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: intervention group or case group; 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	Drug: Folic Acid 5 MG; folic acid tablet of 5mg will be placed on the ulcers 2 times per day for 7 days; Other Names: folacin
Placebo Comparator: control group; placebo drug for oral ulcers	Other: placebo; an inactive drug looking exactly like active drug will be given, patients will be asked to put it on ulcers 2 times per day; Other Names: inactive drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	7 days

Collaborators and Investigators

• Sponsor: Dow University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: July 7, 2021
• First Submitted That Met QC Criteria: July 25, 2021
• First Posted (Actual): August 4, 2021

Study Record Updates

• Last Update Posted (Actual): March 24, 2022
• Last Update Submitted That Met QC Criteria: March 23, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: topical therapy; folic acid; oral ulcers
• Additional Relevant MeSH Terms: Pathologic Processes; Stomatognathic Diseases; Mouth Diseases; Ulcer; Oral Ulcer; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex; Hematinics; Folic Acid
• Other Study ID Numbers: folic acid for oral ulcers

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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