search
Back to results

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

Primary Purpose

Oral Lichen Planus

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Sesame Oil
triamcinolone in orabase
Sponsored by
Mona Taha Mohammed MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Lichen Planus focused on measuring Oral lichen planus, sesame oil, corticosteroid, MDA

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    sesame oil in orabase

    triamcinolone in orabase

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    pain intensit measure
    measured by visual analogue scale where0 no pain and 10 sever pain
    reduction of clinical signs measure
    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)
    measured by reaction with thiobarbituric acid (TBA)

    Full Information

    First Posted
    November 8, 2018
    Last Updated
    August 1, 2019
    Sponsor
    Mona Taha Mohammed MD
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03738176
    Brief Title
    The Efficacy of Topical Sesame Oil Versus Topical Triamcinolone on Oral Lichen Planus and Salivary Level of Oxidative Stress Biomarker [MDA]
    Acronym
    (MDA)
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 16, 2019 (Anticipated)
    Primary Completion Date
    November 16, 2020 (Anticipated)
    Study Completion Date
    December 30, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Mona Taha Mohammed MD

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    use seseme oil and corticosteroid topically for two groups
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Oral Lichen Planus
    Keywords
    Oral lichen planus, sesame oil, corticosteroid, MDA

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Model Description
    sesame oil in orabase(80 gm CMC -20 gm sesame oil)
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    sesame oil in orabase
    Arm Type
    Experimental
    Arm Description
    20 gm sesame oil-80 gm CMC 3 times per day for one month
    Arm Title
    triamcinolone in orabase
    Arm Type
    Active Comparator
    Arm Description
    140 gm triamcinolone-50 gm Na CMC 3 times per day for one month
    Intervention Type
    Drug
    Intervention Name(s)
    Sesame Oil
    Other Intervention Name(s)
    sesame oil gel
    Intervention Description
    Sesame oil(80 gm NaCMC-20 gmSesame oil)
    Intervention Type
    Drug
    Intervention Name(s)
    triamcinolone in orabase
    Other Intervention Name(s)
    kenacorte
    Intervention Description
    triamcinolone 140 gm-Na CMC 50 gm
    Primary Outcome Measure Information:
    Title
    pain intensit measure
    Description
    measured by visual analogue scale where0 no pain and 10 sever pain
    Time Frame
    4 weeks
    Title
    reduction of clinical signs measure
    Description
    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
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Salivary level of oxidative stress biomarker (MDA)
    Description
    measured by reaction with thiobarbituric acid (TBA)
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mona Taha Mohammed Ahamed, Master
    Phone
    01123294474
    Email
    mona.taha@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amal ALI Ali, LEcturer
    Phone
    01156520918
    Email
    amal.ali@dentistry.cu.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mona Taha Mohammed Ahammed, MD
    Organizational Affiliation
    Cairo U
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs