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

NCT ID: NCT03738176

Last Updated: 2019-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-16

Study Completion Date

2020-12-30

Brief Summary

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use seseme oil and corticosteroid topically for two groups

Detailed Description

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* 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.

Conditions

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Oral Lichen Planus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

sesame oil in orabase(80 gm CMC -20 gm sesame oil)
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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sesame oil in orabase

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

Group Type EXPERIMENTAL

Sesame Oil

Intervention Type DRUG

Sesame oil(80 gm NaCMC-20 gmSesame oil)

triamcinolone in orabase

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

Group Type ACTIVE_COMPARATOR

triamcinolone in orabase

Intervention Type DRUG

triamcinolone 140 gm-Na CMC 50 gm

Interventions

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Sesame Oil

Sesame oil(80 gm NaCMC-20 gmSesame oil)

Intervention Type DRUG

triamcinolone in orabase

triamcinolone 140 gm-Na CMC 50 gm

Intervention Type DRUG

Other Intervention Names

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sesame oil gel kenacorte

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mona Taha Mohammed MD

OTHER

Sponsor Role lead

Responsible Party

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Mona Taha Mohammed MD

clinical researcher

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mona Taha Mohammed Ahammed, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo U

Central Contacts

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Mona Taha Mohammed Ahamed, Master

Role: CONTACT

01123294474

Amal ALI Ali, LEcturer

Role: CONTACT

01156520918

Other Identifiers

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2:5:1

Identifier Type: -

Identifier Source: org_study_id

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