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Outcome Measures

Primary Outcomes (1)

Primary Objective
To compare the clinical efficacy of Aloe Vera gel 70% versus triamcinolone acetonide 0.1% gel in the treatment of symptomatic oral lichen planus (OLP) in terms of lesion size and patient pain The assessment will be carried out at 0, 2, 4 and 8 weeks after starting of the treatment protocol then at 12 weeks after the end of the observational period using the following parameters: 1. Clinical scoring (CS) (Thongprasom et al., 2003) 0: Mild represented no lesion/normal mucosa. 1: White striae/no erythematous area. 2: White striae with atrophic area less than 1 cm2 3: White striae with atrophic area more than 1 cm2 4: White striae with erosive area more than 1cm2 2. Visual Analog Scale (VAS) The VAS consisted of a 10-cm horizontal line marked 0-10 (0 no pain; 10 most severe pain experienced). 3. Imaging and measuring of the oral marker lesion the surface area of the lesion will be outlined and measured using specific image software.
12 weeks

Secondary Outcomes (1)

Secondary Objective
12 weeks

Interventions

aloevera gelDrug

Mature fresh leaves of Aloe Vera will be washed with fresh, water, their thick epidermis was removed and the solid mucilaginous gel will be collected in a sterile container. The Aloe Vera (AV) gel will consist of 70% AV mucilage, sorbitol, potassium sorbate, sodium metabisulphite and hydroxyethyl-cellulose Dosage : Four times daily for two months

Group 1 Test Group

Topical Corticosteroid Creams (Triamcinolone acetonide 0.1% and Hydrocortisone 2.5%)Drug

Each 0.1 mg triamcinolone acetonide in a dental gel containing gelatin, pectin, cream flavor, vanilla flavor and carboxymethylcellulose sodium in Plasticized Hydrocarbon Gel, a polyethylene and mineral oil gel base.

Eligibility Criteria

Age25 Years - 60 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Both genders, aged ranged from 25 to 60 years.
Clinically proven painful symptomatic forms of OLP confirmed by the presence of red or erythematous changes, or shallow ulcerations with fine lacy lines at the periphery of the lesion accentuated by stretching and not eliminated by rubbing (Wickham's striae)

Study Sites (5)

Faculty Of Dentistry, Ainshams University.

Al ‘Abbāsīyah, Cairo Governorate, 01234, Egypt

Faculty Of Dentistry, Ainshams University.

Al ‘Abbāsīyah, Cairo Governorate, Egypt

Ainshams University

Cairo, Cairo Governorate, 01234, Egypt

Faculty of dentistry Ainshams University

Cairo, Egypt

Faculty Of Dentistry, Ainshams University.

Cairo, Egypt

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesLichen PlanusLichenoid EruptionsSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TriamcinolonePregnadienesPregnanesSteroids

Study Design

Study Type

interventional

Phase

phase 4

Allocation

RANDOMIZED

Masking

TRIPLE

Who Masked

PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: The study is designed as a Randomized- parallel 2 arm - assessor blinded single center- controlled comparative clinical trial with biochemical analysis

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Post Graduate Researcher , Faculty of dentistry, AinShams University

Efficacy of Aloe Vera Compared to Corticosteroid in Topical Treatment of Oral Lichen Planus and on Salivary Levels of Tumor Necrosis Factor Alpha

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Group 1 Test Group

Group 2 Control group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Group 1 Test Group

Group 2 Control group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations