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