Back to resultsEvaluation of Topical Pomegranate Extracts in Management of Oral Lichen Planus (A Randomized Clinical Trial)
Primary Purpose
Oral Lichen Planus
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Topical pomegranate seeds and peel extracts
Sponsored by
About this trial
This is an interventional treatment trial for Oral Lichen Planus focused on measuring pomegranate, seeds, peel, topical, Oral lichen planus, pain, OHIP-14.
Eligibility Criteria
Inclusion Criteria:
- The study inclusion criteria were patients of both sexes with 18 to 60 years old in age with atrophic type OLP and signed the informed consent
Exclusion Criteria:
- Patients who excluded from the study were smokers, pregnant, lactating ladies and patients under topical and systemic steroids during the last two months. Uncontrolled diabetic patients or hypertension in addition to hepatic and cardiac patients were not included. In addition, any previous history of allergy to pomegranate
Sites / Locations
- Oral Medicine and Periodontology Department
- Faculty of Dentistry, Cairo University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Control group
Group S
Group P
Arm Description
Topical triamcinolone acetonide 0.1% available commercially (Kenacort- in orabase) has been used. Topical corticosteroid treatment has be repeated four times per day for four weeks.
Topical pomegranate seeds extract treatment has been repeated four times per day for four weeks.
Topical pomegranate peel extract treatment has been repeated four times per day for four weeks.
Outcomes
Primary Outcome Measures
visual analog scale (VAS)
Pain assessment scale
Secondary Outcome Measures
Sign score
Score for clinical improvement of the signs
OHIP-14 questionnaire
evaluate the oral health related quality of life
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04193748
Brief Title
Evaluation of Topical Pomegranate Extracts in Management of Oral Lichen Planus (A Randomized Clinical Trial)
Official Title
Evaluation of Topical Pomegranate Extracts in Management of Oral Lichen Planus (A Randomized Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
November 20, 2019 (Actual)
Study Completion Date
December 13, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study was conducted to estimate the hypothesis that the Pomegranate Extracts have no role in management of oral lichen planus
Detailed Description
Lichen planus is a common chronic mucocutaneous disease of uncertain origin that has been shown to affect 0.5% to 2.2% of various populations. The treatment options for OLP are numerous and include topical and systemic agents. Steroids were found effective in management of OLP with contraindicated use in some systemic diseases and with multiple side effects with its prolonged use. Pomegranates have been known for hundreds of years for their multiple health benefits, including anti-inflammatory activity. The recent surge indicates that pomegranates and their extracts may serve as natural alternatives to drugs which can offer a possible management of OLP decreasing pain and discomfort associated with this chronic condition.The aim of this study was the evaluation of the effect of topical pomegranate extracts in management of oral lichen planus lesions (OLP).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Lichen Planus
Keywords
pomegranate, seeds, peel, topical, Oral lichen planus, pain, OHIP-14.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Masking Description
The clinical outcomes were assessed by an investigator masked about the treatment modality that has been used
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Topical triamcinolone acetonide 0.1% available commercially (Kenacort- in orabase) has been used. Topical corticosteroid treatment has be repeated four times per day for four weeks.
Arm Title
Group S
Arm Type
Experimental
Arm Description
Topical pomegranate seeds extract treatment has been repeated four times per day for four weeks.
Arm Title
Group P
Arm Type
Experimental
Arm Description
Topical pomegranate peel extract treatment has been repeated four times per day for four weeks.
Intervention Type
Drug
Intervention Name(s)
Topical pomegranate seeds and peel extracts
Intervention Description
Topical pomegranate seeds and peel extracts in the form of gel
Primary Outcome Measure Information:
Title
visual analog scale (VAS)
Description
Pain assessment scale
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Sign score
Description
Score for clinical improvement of the signs
Time Frame
4 weeks
Title
OHIP-14 questionnaire
Description
evaluate the oral health related quality of life
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The study inclusion criteria were patients of both sexes with 18 to 60 years old in age with atrophic type OLP and signed the informed consent
Exclusion Criteria:
Patients who excluded from the study were smokers, pregnant, lactating ladies and patients under topical and systemic steroids during the last two months. Uncontrolled diabetic patients or hypertension in addition to hepatic and cardiac patients were not included. In addition, any previous history of allergy to pomegranate
Facility Information:
Facility Name
Oral Medicine and Periodontology Department
City
Cairo
Country
Egypt
Facility Name
Faculty of Dentistry, Cairo University
City
Giza
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Because the research not published yet.
Learn more about this trial
Evaluation of Topical Pomegranate Extracts in Management of Oral Lichen Planus (A Randomized Clinical Trial)
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