| CTRI Number |
CTRI/2025/08/093309 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
31/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing how well Propolis (a natural bee product) works compared to Triamcinolone acetonide (a commonly used steroid medicine) when applied to the mouth to treat painful symptoms of oral lichen planus. Participants were randomly given one of the two treatments to see which worked better. |
|
Scientific Title of Study
|
A Comparative Evaluation of Clinical Efficacy of Topical application of Propolis with triamcinolone acetonide in the management of symptomatic oral lichen planus: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sneha Sarang |
| Designation |
Post graduate student |
| Affiliation |
Sinhgad dental college and hospital, Pune |
| Address |
Department of Oral Medicine and Radiology, (2A dept), ground floor, Sinhgad Dental College and Hospital, S. No. 44/1, Vadgaon Budruk, Off, Sinhgad Rd, Pune, Maharashtra 411041
Pune
MAHARASHTRA
411041
India |
| Phone |
08999536588 |
| Fax |
|
| Email |
snehaaasarang@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Mahesh Chavan |
| Designation |
Professor and Head of Department |
| Affiliation |
Sinhgad dental college and hospital, Pune |
| Address |
Department of Oral Medicine and Radiology, (2A dept), ground floor, Sinhgad Dental College and Hospital, S. No. 44/1, Vadgaon Budruk, Off, Sinhgad Rd, Pune, Maharashtra 411041
Pune
MAHARASHTRA
411041
India |
| Phone |
9823623445 |
| Fax |
|
| Email |
drmaheshschavan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sneha Sarang |
| Designation |
Post graduate student |
| Affiliation |
Sinhgad dental college and hospital, Pune |
| Address |
Department of Oral Medicine and Radiology, (2A dept), ground floor, Sinhgad Dental College and Hospital, S. No. 44/1, Vadgaon Budruk, Off, Sinhgad Rd, Pune, Maharashtra 411041
Pune
MAHARASHTRA
411041
India |
| Phone |
08999536588 |
| Fax |
|
| Email |
snehaaasarang@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Sneha Sarang |
| Address |
Department of Oral Medicine and Radiology, (2A dept), ground floor, Sinhgad Dental College and Hospital, S. No. 44/1, Vadgaon Budruk, Off, Sinhgad Rd, Pune, Maharashtra 411041 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sneha Sarang |
Sinhgad dental college and hospital, Pune |
Department of Oral Medicine and Radiology, (2A dept), ground floor,S. No. 44/1, Vadgaon Budruk, Off, Sinhgad Rd, Pune, Maharashtra 411041
Pune
MAHARASHTRA |
08999536588
snehaaasarang@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K137||Other and unspecified lesions of oral mucosa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Topical 0.1% Triamcinolone acetonide gel |
Patients in Group II will be given Topical 0.1% Triamcinolone acetonide to apply on the affected site 3 times a day for 15 days
The active treatment duration for each group will be for a period of 15 days. The patients will be recalled and scheduled for an appointment on 7th and 15th day and the clinical evaluation will be done and recorded. Regular telephonic calls as a reminder for recall appointments will be made to avoid patient drop out on follow-up.
The following clinical parameters were assessed during follow-up:
1.Pain: NRS
2.Erythema and ulceration: 3.MOMI
Side effects
|
| Intervention |
Topical propolis gel |
Oral lichen planus Patients in Group I will be given Topical Propolis to apply on the affected site 3 times a day for 15 days
The active treatment duration for each group will be for a period of 15 days. The patients will be recalled and scheduled for an appointment on 7th and 15th day and the clinical evaluation will be done and recorded. Regular telephonic calls as a reminder for recall appointments will be made to avoid patient drop out on follow-up.
The following clinical parameters were assessed during follow-up:
1.Pain
2.Erythema and ulceration: 3.MOMI
Side effects |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients with clinically diagnosed atrophic/erosive OLP(based on modified
WHO clinical criteria, 2003)
2 Individuals willing to be a part of the study, who sign the informed consent
form, and who find it convenient to appear for follow-ups as required by
the study.
3 Patients who had not used systemic or topical glucocorticosteroids for at
least the past 2 weeks
4 Patients who agree not to use any other medication such as analgesics and
Anesthetics in either topical form or systemic form during the study. |
|
| ExclusionCriteria |
| Details |
1 Patients with lichenoid lesions thought to arise as a hypersensitivity
reaction to drugs and dental materials
2 Patients on long-term glucocorticosteroid therapy
3 Pregnant and lactating female patients
4 Patients allergic to bee products |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of topical propolis in comparison with topical triamcinolone acetonide in symptomatic oral lichen planus in following parameters
1. Pain
2. Erythema and ulceration
3. Side effects
|
The active treatment duration for each group will be for a period of 15 days. The patients will be recalled and scheduled for an appointment on 7th and 15th day and the clinical evaluation will be done and recorded. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Oral lichen planus (OLP) is a chronic autoimmune disease causing inflammation on mucocutaneous area. The world prevalence for this lesion is 1.01%, more commonly found in women than men with a 2:1 ratio, respectively, and more common in age 30-60 years. OLP has been classified as an oral potentially malignant disorder with a malignant transformation rate ranging from 0 to 12.5% in different studies10 The etiology of this lesion remains unclear until today. However, few possible etiologies have been identified, such as hypersensitivity reaction, autoimmune reaction, psychological stress, and the still-debated viral infection. The widely recognized and generally accepted feature of OLP is related to its possible association with some psychological disorders, among which are anxiety, depression, and stress. As the exact causative factor for OLP is a matter of conflict, the failure to achieve appropriate or exact treatment for it may be the reason for its incomplete regression. The first line of treatment for OLP has been corticosteroids, but because of their adverse effects1 However, continuous and prolonged use is associated with many systemic adverse effects such as bad taste, nausea, facial swellings, SHORT STUDY SYNOPSIS OF PROPOSED TOPIC dryness, mucosal atrophy, candidal infection, granuloma formation, hypersensitivity reactions, delayed wound healing and in later stages; hypothalamus pituitary adrenal suppression ; alternative therapeutic approaches are being carried out. Recently, use of natural drugs, such as propolis, has gained considerable interest. Propolis is a resinous sticky substance produced naturally by bees, and it consists of the exudates of plants mixed with enzymes, wax, and pollen. The term “propolis” is Greek in origin and, in the context of bees, means “defense of the hive.” As the term suggests, propolis is used by bees for hive protection against bacteria, viruses, fungi, and parasites1. It is collected by the honey bees from the sap, leaves, and buds of plants, and then mixed with secreted beeswax. It has been used in folk medicine for thousands of years and is also known as Russian penicillin1. Propolis being very high in bioflavonoid content has antioxidant, antibacterial, antifungal, antiviral, immunomodulatory and anti-inflammatory properties. These properties have prompted investigators to check its efficacy on various oral diseases, namely oral lichen planus (LP), oral candidiasis, recurrent aphthous stomatitis, radiation mucositis16, denture stomatitis, and herpes labialis Furthermore, there is growing interest within the dental field in the use of natural medicinal products with inherent antimicrobial activity, such as propolis. it not only represents a promising alternative antimicrobial agent but also has a range of favorable biological activities, making its use in preventing or treating various dental and oral conditions1. “This Study aims to provide an overview of the applications of propolis in the symptoms of OLP and highlighting its clinical effectiveness and identifying research gaps that need to be addressed” |