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

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)

use seseme oil and corticosteroid topically for two groups

Study Overview

• Status: Unknown
• Conditions: Oral Lichen Planus
• Intervention / Treatment: Drug: Sesame Oil; Drug: triamcinolone in orabase

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Mona Taha Mohammed Ahamed, Master; Phone Number: 01123294474; Email: mona.taha@dentistry.cu.edu.eg
• Study Contact Backup: Name: Amal ALI Ali, LEcturer; Phone Number: 01156520918; Email: amal.ali@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain intensit measure	measured by visual analogue scale where0 no pain and 10 sever pain	4 weeks
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	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary level of oxidative stress biomarker (MDA)	measured by reaction with thiobarbituric acid (TBA)	4 weeks

Collaborators and Investigators

• Sponsor: Mona Taha Mohammed MD
• Investigators: Principal Investigator: Mona Taha Mohammed Ahammed, MD, Cairo U

Study record dates

Study Major Dates

• Study Start (Anticipated): December 16, 2019
• Primary Completion (Anticipated): November 16, 2020
• Study Completion (Anticipated): December 30, 2020

Study Registration Dates

• First Submitted: November 8, 2018
• First Submitted That Met QC Criteria: November 9, 2018
• First Posted (Actual): November 13, 2018

Study Record Updates

• Last Update Posted (Actual): August 2, 2019
• Last Update Submitted That Met QC Criteria: August 1, 2019
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: corticosteroid; MDA; Oral lichen planus; sesame oil
• Additional Relevant MeSH Terms: Skin Diseases; Stomatognathic Diseases; Mouth Diseases; Skin Diseases, Papulosquamous; Lichenoid Eruptions; Lichen Planus, Oral; Lichen Planus; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone
• Other Study ID Numbers: 2:5:1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No