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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03738176
Other study ID # 2:5:1
Secondary ID
Status Not yet recruiting
Phase Early Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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