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Oral Zinc Supplement as Adjunctive Therapy for Erosive Oral Lichen Planus

Primary Purpose

Oral Lichen Planus

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Oral zinc supplement
triamcinolone acetonide Oral paste
Sponsored by
Hams Hamed Abdelrahman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Lichen Planus

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All patients involved in this clinical trial will have symptomatic OLP Exclusion Criteria: Smokers or tobacco users will be excluded from this clinical trial. Pregnant and lactating females. Any patient that has history of cancer, kidney, liver or other autoimmune disease will be excluded from this study. Patients showing dysplastic changes in their confirmatory biopsy specimen will be also excluded. Any patients presenting with extra oral lichen planus lesions will be excluded. Suspicious lesions of both lichenoid contact reaction and lichenoid drug reaction lesions will be excluded. Vitamin administration intake within the last 3 months

Sites / Locations

  • Alexandria Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test group

control group

Arm Description

Outcomes

Primary Outcome Measures

Change in oral lesions
Thongprasom scoring system will be used for the measurement of objective outcomes; score 5 was assigned to patients having white striae with erosive areas >1 cm2, score 4 assigned to patients with white striae and erosive areas <1 cm2, score 3 assigned to those having white striae and atrophic areas >1 cm2, score 2 assigned to those having white striae and atrophic areas <1 cm2, score 1 assigned to those having only white striae, and score 0 assigned to normal mucosa.
Change in MMP-9 level
Whole unstimulated saliva will be collected from all participants

Secondary Outcome Measures

Change in pain
Patients will be asked to assign a numerical score representing the intensity of their symptoms on a scale from 0 to 10, with 0 being no symptoms and 10 being worst imaginable symptoms

Full Information

First Posted
September 12, 2023
Last Updated
September 12, 2023
Sponsor
Hams Hamed Abdelrahman
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1. Study Identification

Unique Protocol Identification Number
NCT06042010
Brief Title
Oral Zinc Supplement as Adjunctive Therapy for Erosive Oral Lichen Planus
Official Title
Efficacy of Oral Zinc Supplement as an Adjunctive Therapy for Erosive Oral Lichen Planus (a Randomized, Controlled Clinical Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 5, 2023 (Actual)
Primary Completion Date
February 14, 2023 (Actual)
Study Completion Date
February 14, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hams Hamed Abdelrahman

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Lichen Planus (LP) is a chronic mucocutaneous inflammatory disease and considered as T-cell mediated autoimmune disorder. Zinc is a potent antioxidant micronutrient that contributes to the proper functioning of the antioxidant defense system. In addition, this mineral protects cells against inflammation by oxidative stress, because it acts in the stabilization of cell membrane. It also maintains macrophage and neutrophil functions, natural killer cell activity, and complement activity. Matrix metalloproteinases (MMPs) are a family of zinc-containing endopeptidases and have the main function of proteolytic degradation of connective tissue matrix proteins. Zinc prevents (MMP-1) activation and inhibition of the T-cell accumulation in (OLP) through inhibiting of (MMP-9). Aim of the study: To evaluate and compare the efficacy of adding oral zinc supplementation 50 mg to 0.1%Triamcinolone orabase (TA)versus 0.1%Triamcinolone orabase alone on the healing of erosive OLP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Lichen Planus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test group
Arm Type
Experimental
Arm Title
control group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Oral zinc supplement
Intervention Description
patients received oral Zinc picolinate 50mg for 6 weeks as single morning dose along with 0.1%
Intervention Type
Drug
Intervention Name(s)
triamcinolone acetonide Oral paste
Intervention Description
patients will received 0.1%triamcinolone acetonide Oral paste twice daily alone for 6weeks.
Primary Outcome Measure Information:
Title
Change in oral lesions
Description
Thongprasom scoring system will be used for the measurement of objective outcomes; score 5 was assigned to patients having white striae with erosive areas >1 cm2, score 4 assigned to patients with white striae and erosive areas <1 cm2, score 3 assigned to those having white striae and atrophic areas >1 cm2, score 2 assigned to those having white striae and atrophic areas <1 cm2, score 1 assigned to those having only white striae, and score 0 assigned to normal mucosa.
Time Frame
Baseline, 6 weeks, 12 weeks
Title
Change in MMP-9 level
Description
Whole unstimulated saliva will be collected from all participants
Time Frame
Baseline, 6 weeks, 12 weeks
Secondary Outcome Measure Information:
Title
Change in pain
Description
Patients will be asked to assign a numerical score representing the intensity of their symptoms on a scale from 0 to 10, with 0 being no symptoms and 10 being worst imaginable symptoms
Time Frame
Baseline, 6 weeks, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients involved in this clinical trial will have symptomatic OLP Exclusion Criteria: Smokers or tobacco users will be excluded from this clinical trial. Pregnant and lactating females. Any patient that has history of cancer, kidney, liver or other autoimmune disease will be excluded from this study. Patients showing dysplastic changes in their confirmatory biopsy specimen will be also excluded. Any patients presenting with extra oral lichen planus lesions will be excluded. Suspicious lesions of both lichenoid contact reaction and lichenoid drug reaction lesions will be excluded. Vitamin administration intake within the last 3 months
Facility Information:
Facility Name
Alexandria Faculty of Dentistry
City
Alexandria
Country
Egypt

12. IPD Sharing Statement

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Oral Zinc Supplement as Adjunctive Therapy for Erosive Oral Lichen Planus

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