Aims: Aphthous lesions are one of the most common diseases of the oral cavity. They can cause severe pain, and there is no definite cure. The purpose of this study was to determine the efficacy of Zataria multiflora (ZM, a thyme-like plant) essential oil for the control and treatment of aphthous lesions.
Design: This study was triple blind clinical trial.
Participants: This study was performed on 28 patients who were randomly selected from all patients suffering from recurrent aphthous lesions who were admitted to the Department of Oral Medicine, Faculty of Dentistry, Babol University of Medical Sciences in the north of Iran. The patients were divided into ZM- and placebo-treated groups. Inclusion criteria were as follows:
1) Presence of a minor solitary aphthous lesion in labial or buccal epithelium.
2) No usage of other treatments for aphthous lesions.
3) No reduction in pain, pain intensity or burning sensation at the time of admission compared to the first days of occurrence of the lesion.
4) Willingness to participate in the study.
5) Age between 18 and 40 years.
Patients were excluded from the study:
with any systemic diseases ,pregnant patients; those with aphthous lesions older than 4 days and those who declined entering the study.
How to study: Patient were divided into two groups (eight men and six women in each group) and given ZM or placebo (control). The healing time, pain intensity and aphthous zone diameter were recorded for each patient. Data were analyzed using Mann-Whitney and Friedman tests.
Interventions: The patients received a bottle of 0.5% ZM essential oil or a bottle of placebo (distilled water with a cap scented with ZM essential oil). Standard ZM essence was obtained from Barij Essence Pharmaceutical Company (Kashan, Iran).
Major outcome measure: Therapeutic effects of Zataria Multiflora Essential Oil on recurrent oral aphthous lesion that The pain intensity was measured using a VAS (visual analog scale), which the patients completed every day for 10 days (before and after treatment).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201408076926N2
Registration date:2014-08-28, 1393/06/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-08-28, 1393/06/06
Registrant information
Name
Shaghayegh Nooribayat
Name of organization / entity
Babol Univercity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 911 220 0198
Email address
sh.nooribayat@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Sciences
Expected recruitment start date
2012-05-28, 1391/03/08
Expected recruitment end date
2013-06-25, 1392/04/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Therapeutic effects of Zataria Multiflora Essential Oil on recurrent oral aphthous lesions
Public title
Therapeutic effects of Zataria Multiflora Essential Oil on recurrent oral aphthous lesions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria were as follows:
1) Presence of a minor solitary aphthous lesion in labial or buccal epithelium.
2) No usage of other treatments for aphthous lesions.
3) No reduction in pain, pain intensity or burning sensation at the time of admission compared to the first days of occurrence of the lesion.
4) Willingness to participate in the study.
5) Age between 18 and 40 years old.
Patients were excluded from the study:
with any systemic diseases; pregnant patients; those with aphthous lesions older than 4 days and those who declined entering the study.
Age
From 18 years old to 40 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol University of Medical Sciences
Street address
Babol University of Medical Sciences
City
Babol
Postal code
Approval date
2011-09-23, 1390/07/01
Ethics committee reference number
5467
Health conditions studied
1
Description of health condition studied
Recurrent oral aphthous lesions
ICD-10 code
K12.0
ICD-10 code description
Recurrent oral aphthae
Primary outcomes
1
Description
Recurrent oral aphthous lesion
Timepoint
Days: 0, 5, 7 and 10
Method of measurement
The healing time, pain intensity and aphthous zone diameter
Secondary outcomes
1
Description
Pain
Timepoint
Days: 0, 5, 7 and 10
Method of measurement
Visual analog scale
Intervention groups
1
Description
in intervention group:a bottle of 0.5% ZM essential oil
Category
Treatment - Drugs
2
Description
interventon in control group: a bottle of placebo (distilled water with a cap scented with ZM essential oil)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Oral Medicine, Faculty of Dentistry, Babol University of Medical Sciences
Full name of responsible person
Dr. Neda Babaee
Street address
Faculty of Dentistry, Babol University of Medical Sciences
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Ali akbar Moghaddam nia
Street address
Department of Pharmacology Babol University of Meical Scienceس
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Dental faculty, Babol University of Medical Sciences
Full name of responsible person
Shaghayegh Nooribayat
Position
Postgraduated Student
Other areas of specialty/work
Street address
Research Committee, Dental faculty, Babol University of Medical Sciences