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

Oral Lichen Planus Clinical Trial

— (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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03738176
• Other study ID #: 2:5:1
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: December 16, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: November 2018
• Source: Cairo University
• Contact: Mona Taha Mohammed Ahamed, Master
• Phone: 01123294474
• Email: mona.taha[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

use seseme oil and corticosteroid topically for two groups

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 30, 2020
• Est. primary completion date: November 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lichen Planus
• Lichen Planus, Oral
• Oral Lichen Planus

Intervention

Drug:
• Sesame Oil
Sesame oil(80 gm NaCMC-20 gmSesame oil)
• triamcinolone in orabase
triamcinolone 140 gm-Na CMC 50 gm

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mona Taha Mohammed MD

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain intensit measure	measured by visual analogue scale where0 no pain and 10 sever pain	4 weeks
Primary	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	Salivary level of oxidative stress biomarker (MDA)	measured by reaction with thiobarbituric acid (TBA)	4 weeks