Randomised,parallel group trial with blined outcome assessment
Settings and conduct
This study be doing on patient with oral lichen planus who referred to Oral medicin Department of shahid Beheshti university.In one group ,Nanocurcumin gel with triamcinolone mouthwash and another group placebo gel with triamcinolon mouthwash prescribed for one mouth..Gels with same coulure and shap gave to the patients.Rsercher and patient dont aware type of drugs. Clinically evalution
and assessment lesions of patient doing with one persion.
Participants/Inclusion and exclusion criteria
All patient has typicaly Lichen Planus symptomatic(erosive-atrophic) symptoms such as soreness and burning sensation
Inclusion criteria for axceptance of this study excistance of vickham sreria and for the case difficulty for diagnose were doing histopathologig assessment .patient don’t therapy with topical corticostreroid within 2 weeks ago and dont use systemic corticostroid within one mounth ago and dont use of analgesic
Intervention groups
Group A reciving nanocurcumin gel%1 and triamcinolone acetonid mouthwash %0.1 and Group B reciving with triamcinolone aceetonid mouth wash%0.1 and gel placebo.patient aqueous mouthwash for 1 minute ,3 times a day for one mounth.After use of mouthwash patient apply the gel in the lesion of the mouth.This protocol was described to the patient.
Main outcome variables
Oral lesions, recovery rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190523043678N1
Registration date:2019-06-11, 1398/03/21
Registration timing:retrospective
Last update:2019-06-11, 1398/03/21
Update count:0
Registration date
2019-06-11, 1398/03/21
Registrant information
Name
Shahzad Gholami hasanabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7704 0184
Email address
shahzad.kf@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-17, 1397/07/25
Expected recruitment end date
2019-03-06, 1397/12/15
Actual recruitment start date
2018-11-16, 1397/08/25
Actual recruitment end date
2019-05-05, 1398/02/15
Trial completion date
2019-05-05, 1398/02/15
Scientific title
Evaluation of Effectiveness of Combination Nano micelle Curcumin Gel %1with Triamcinolone Acetonide Mouthwash%0.1 in Oral Lichen planus
Public title
Evaluation of Combination Nano micelle Curcumin with Triamcinolone Acetonide in Oral Lichen planus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with sympathetic lichen planus (erosive or atrophic) with burning or pain
Clinical diagnosis (Wicham lines) and in cases where it was difficult to achieve a definitive diagnosis of the lesion, a histopathologic evaluation was used
The patient has not been taking topical corticosteroid therapy over the past two weeks, he has not used systemic corticosteroids during the past month.
The patient has not used Analgesic and anestheticpain
Exclusion criteria:
Patients with lichenoid lesions caused by drugs or dental materials
pregnant or lactation
Patients who have other lesions similar to systemic leukoplakia and systemic lupus in conjunction with lichen planus
Historh of malignancy
Non-cooperative patients and patients who do not take medication
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Four blocks are considered as two assignments for the intervention group and two allocations for the control group. Six possible modes of permutation of treatments are listed, and each one is written on a card. Each time a block is selected among them, and the order in the block is to be marked to allocate treatment for all 50 (12 blocks). Randomization is done by a design specialist. Hiding is done through the main investigator. On each of the 30 cards, we write a sequence of sequences and put them in sealed envelopes. The envelopes are placed in the box, respectively. For participants, the order of entry of one of the envelopes is allocated respectively.
Blinding (investigator's opinion)
Double blinded
Blinding description
Curcumin gel and placebo gel are given in tubes of a shape and color to patients.
In this study, the investigator and patient do not know the type of drugs (double blind)
Examination of patients and evaluation of oral lesions before and after oral administration by one person.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of Shahid Beheshti University of Medical sciences.
Street address
Schoole of Dentistry:Daneshjoo BLVD,Tabnak st,Chamran Highway,Tehran ,Iran
City
Thehran
Province
Tehran
Postal code
1983963113
Approval date
2018-10-14, 1397/07/22
Ethics committee reference number
IR.SBMU.DRC.REC.1397.014
Health conditions studied
1
Description of health condition studied
Oral Lichen Planus
ICD-10 code
L43
ICD-10 code description
Lichen Planus
Primary outcomes
1
Description
Severity and size of the lesion
Timepoint
Base Day (0), Day 14, Day 28
Method of measurement
with a scaled abslang
2
Description
Reduction in severity of lessions
Timepoint
Base Day (0), Day 14, Day 28
Method of measurement
Efficacy Index
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: In this group, patients receiving 1% Nanocorcinem gel with triamcinolone mouthwash receive one-tenth of a percent for three weekly doses per week. (Half an hour after each meal, use a medication and use it for half an hour after eating and drinking). After using mouthwash for 5 minutes, the gel should be swallowed. This instruction is explained to all patients.
Category
Treatment - Drugs
2
Description
Control group: In this group, patients receiving placebo gel and triamcinolone mouthwash receive one-tenth of a percent for use at weekly intervals three times a day. (Half an hour after each meal, use a medication and use it for half an hour after eating and drinking). After using mouthwash for 5 minutes, the gel should be swallowed. This instruction is explained to all patients.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry of Shahid Beheshti University of Medical sciences
Full name of responsible person
Shahzad Gholami
Street address
Schoole of Dentistry:Daneshjoo BLVD,Tabnak st,Chamran Highway,Tehran ,Iran