(MDA): The Efficacy of Topical Sesame Oil Versus Topical Triamcinolone on Oral Lichen Planus and Salivary Level of Oxidative Stress Biomarker [MDA]

Sponsor

Mona Taha Mohammed MD (Other)

Overall Status

Unknown status

CT.gov ID

NCT03738176

Collaborator

(none)

Enrollment

Arms

12.5

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

use seseme oil and corticosteroid topically for two groups

Condition or Disease	Intervention/Treatment	Phase
Oral Lichen Planus	Drug: Sesame Oil Drug: triamcinolone in orabase	Early Phase 1

Detailed Description

The enrolled patients will be divided randomly into two groups.
Test group will receive topical sesame oil (3 times /day after eating) for a month.
Control group will receive topical corticosteroid (3 times /day after eating) for a month.
Assessment of the appearance score and severity of pain as well as the clinical parameter outcome will be done at baseline and at the end of two and four weeks and will be recorded in the patients' questionnaires & by clinical sign score . MDA will be measured at the baseline & at the end of four weeks after treatment.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

sesame oil in orabase(80 gm CMC -20 gm sesame oil)sesame oil in orabase(80 gm CMC -20 gm sesame oil)

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Efficacy of Topical Sesame Oil in Orabase Versus Topical Triamcinolone in Orabase on Oral Lichen Planus and Salivary Level of Oxidative Stress Biomarker, Malondialdehyde [MDA] : Randomized Clinical Trial (RCT)

Anticipated Study Start Date :

Dec 16, 2019

Anticipated Primary Completion Date :

Nov 16, 2020

Anticipated Study Completion Date :

Dec 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: sesame oil in orabase 20 gm sesame oil-80 gm CMC 3 times per day for one month	Drug: Sesame Oil Sesame oil(80 gm NaCMC-20 gmSesame oil) Other Names: sesame oil gel
Active Comparator: triamcinolone in orabase 140 gm triamcinolone-50 gm Na CMC 3 times per day for one month	Drug: triamcinolone in orabase triamcinolone 140 gm-Na CMC 50 gm Other Names: kenacorte

Arm

Intervention/Treatment

Experimental: sesame oil in orabase

20 gm sesame oil-80 gm CMC 3 times per day for one month

Drug: Sesame Oil

Sesame oil(80 gm NaCMC-20 gmSesame oil)

Other Names:

sesame oil gel

Active Comparator: triamcinolone in orabase

140 gm triamcinolone-50 gm Na CMC 3 times per day for one month

Drug: triamcinolone in orabase

triamcinolone 140 gm-Na CMC 50 gm

Other Names:

kenacorte

Outcome Measures

Primary Outcome Measures

pain intensit measure [4 weeks]
measured by visual analogue scale where0 no pain and 10 sever pain
reduction of clinical signs measure [4 weeks]
Thongprasom Score 5 = white striae with erosive area = 1 cm2 Score 4 = white striae with erosive area < 1 cm2 Score 3 = white striae with erosive area > 1 cm2 Score 2 = white striae with atrophic area < 1 cm2 Score 1 = mild white striae only Score 0 = no lesion normal

Secondary Outcome Measures

Salivary level of oxidative stress biomarker (MDA) [4 weeks]
measured by reaction with thiobarbituric acid (TBA)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients who will be clinically diagnosed as having atrophic &/or erosive oral lichen planus.
Patients with no history of taking topical corticosteroids for the last 2 months and systemic corticosteroid for the last 6 months
Patients who agree to take medication and follow up .

Exclusion Criteria:

Pregnant and lactating ladies.
Patients with history of topical steroids during last 2 months & systemic steroids during last 6 months.
Patients with recent dental filling associated with the lesion or associated with recent drug administration.
Patient with history of diabetes or hypertension or those with positive HCV ab or HBs Ag.