This study assessed the efficacy of mouthwash with honey compared with hydrogen peroxide in oral lesions healing in Pemphigus patients. A randomized clinical trial was carried on 49 patients with oral pemphigus lesions. Patients randomly divided into experimental and control groups. Experimental group received honey mouthwash 12.5%, daily, half an hour after each meal. Control group received H2O2 mouthwash 1.5%, daily, half an hour after each meal. Patients were assessed for 10 days. Data were collected by questionnaire: Oral Mucositis Visual Assessment Guide of WHO, visual analog scale of pain intensity and time Diaries.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902142846N4
Registration date:2010-06-16, 1389/03/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-06-16, 1389/03/26
Registrant information
Name
Tahereh Ashktorab
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 1543
Email address
t_ashktorab@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
private
Expected recruitment start date
2009-10-07, 1388/07/15
Expected recruitment end date
2010-02-04, 1388/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of honey mouthwash with hydrogen peroxide mouthwash on oral lesions healing in patients with Pemphigus
Public title
Efficacy of honey mouthwash on oral lesions healing in patients with Pemphigus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with oral pemphigus lesions (grades of 1-3 were considered as oral ulcers), treated with classical pemphigus (a corticosteroid and immunosuppressive). Exclusion criteria: any broad spectrum antibiotics in the patient medication instructions, underlying disease (diabetes, infections, mouth and teeth), history of allergy to honey, history of chemotherapy and radiation therapy for head and neck and lesions worsening during using honey mouthwash (in this case, treatment will be returned to the routine).
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The International and Virtual Branch of Shahid Beheshti University of Medical Sciences
Street address
NO19, Shahid Abaspoor St, Next to Shahid Hemmat Bridge, Valiasre Ave
City
Tehran
Postal code
3693-14155
Approval date
2009-10-20, 1388/07/28
Ethics committee reference number
675/116
Health conditions studied
1
Description of health condition studied
oral lesions in pemphigus
ICD-10 code
L10
ICD-10 code description
Pemphigus
Primary outcomes
1
Description
grade of oral lesions
Timepoint
at the begining and then every other day for ten days
Method of measurement
Oral Mucositis Visual Assessment Guide of WHO
Secondary outcomes
1
Description
healing erythema
Timepoint
every other day/and till 10 day
Method of measurement
Oral Mucositis Visual Assessment Guide of WHO
2
Description
Reducing pain in oral lesions
Timepoint
every other day/and till 10 day
Method of measurement
visual analog scale of pain intensity
3
Description
Improvement patient’s dietary intake
Timepoint
every other day/and till 10 day
Method of measurement
Oral Mucositis Visual Assessment Guide of WHO
Intervention groups
1
Description
Intervention group: honey mouthwash 12.5%, daily, half an hour after each meal
Category
Treatment - Other
2
Description
Control group: H2O2 mouthwash 1.5%, daily, half an hour after each meal