Therapeutic Effect of Folic Acid in Healing of Oral Ulcers

NCT ID: NCT04989049

Last Updated: 2022-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2022-12-31

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.

Conditions

Oral Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Folic Acid 5 MG

Intervention Type: DRUG

folic acid tablet of 5mg will be placed on the ulcers 2 times per day for 7 days

control group

placebo drug for oral ulcers

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

an inactive drug looking exactly like active drug will be given, patients will be asked to put it on ulcers 2 times per day

Interventions

Folic Acid 5 MG

folic acid tablet of 5mg will be placed on the ulcers 2 times per day for 7 days

Intervention Type: DRUG

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

Intervention Type: OTHER

Other Intervention Names

folacin; inactive drug

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dow University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Tahseen Shabbir Khooharo

post graduate trainee

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Tahseen S Khooharo, MSc oral medicine

Role: CONTACT

tahseen_shabbir@hotmail.com

+923362533399

Other Identifiers

folic acid for oral ulcers

Identifier Type: -

Identifier Source: org_study_id