Comparative study on Oak gall oil and Triphala oil in the treatment of oral leukoplakia and erythroplakia

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2016/10/007415
• Date of registration: 27-10-2016
• Prospective Registration: No
• Primary sponsor: Dr Sharmila S
• Public title: Comparative study on Oak gall oil and Triphala oil in the treatment of oral leukoplakia and erythroplakia
• Scientific title: Comparison of effectiveness of Oak gall oil and Triphala oil as an adjuvant in the reversal of oral leukoplakia and erythroplakia â??A double blinded randomized clinical trial
• Date of first enrolment: 02-05-2016
• Target sample size: 40
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=14799
• Study type: Interventional
• Study design: Randomized, Parallel Group, Active Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant and Investigator Blinded
• Phase: Phase 3

Countries of recruitment

India

Contacts

• Name: Dr MB Aswath Narayanan
• Affiliation: Tamilnadu Government Dental College and Hospital,Chennai

• Name: Dr Sharmila S
• Affiliation: Tamilnadu Government Dental College and Hospital,Chennai

Key inclusion & exclusion criteria

Inclusion criteria: Outpatients who are current tobacco users and are diagnosed with either leukoplakia and erythroplakia

Histologically mild or moderate epithelial dysplasia


Exclusion criteria: Subjects with malignant tumours of oral cavity

Subjects with any systemic diseases

Subjects who are pregnant or lactating

Subjects who are physically and mentally challenged

Subjects with known hypersensitivity to toluidine blue

Subjects with dental conditions such as orthodontic appliances or prostheses that may interfere with the examination

Subjects who are currently receiving any type of cessation, alcohol or illicit drug treatment at the time of recruitment

Subjects who are under medication for systemic illness

Leukoplakia with p2 grading of histopathological evaluation by vanderwaal et al 2000



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- oral leukoplakia and erythroplakia

Intervention(s)

Intervention1: oak gall oil: Arm A - oak gall powder is mixed with coconut oil in equal parts and patients are instructed to apply 2ml of the oil topically over the lesion four times a day after food for a period of six weeks
Control Intervention1: Triphala oil: Arm B - triphala powder is mixed with coconut oil in equal parts and patients are instructed to apply 2ml of the oil topically over the lesion four times a day after food for a period of six weeks

Primary Outcome(s)

Assessment of reversal of oral leukoplakia and erythroplakia both clinically and histologically.Timepoint: At baseline,sixth week and at the end of third month

Secondary Outcome(s)

Self -reported abstinence from the tobacco habit

Timepoint: At baseline, sixth week and third month

Secondary ID(s)

nil

Source(s) of Monetary Support

Department of Public health Dentistry, Tamilnadu Government Dental college and hospital,Chennai

Ethics review

Status: Approved
Approval date: 17/03/2016
Contact:

Institutional Ethics Committee