evaluation the effect of honey on tooth extraction wound healing in children 4‒9 years of age.
Design
clinical trial with control group, with parallel groups and randomized
Settings and conduct
This study is a randomized clinical trial. In this study, 51 patients aged 4 to 9 years who referred to the pediatric department of Dental School of Tehran University of Medical Sciences who needed to remove a primary molar were randomly assigned to the study. The children were then randomly divided into two groups. In the first group, after dental extraction, the dentist placed a layer of honey on the wet gel and with the help of the applicator, and the gas was placed on socket, and the second group did not use honey. On the third and seventh day after extraction, the size of the ulcers was measured using a digital caliper and the result was multiplied by the two number ultimate wound sizes.
Participants/Inclusion and exclusion criteria
children 4‒9 years of age
Intervention groups
after tooth extraction a dentist paced a 1-mm layer of honey with the use of an applicator on a piece of gauze moistened with normal saline solution. The honey was freshly acquired from the Iranian Kurdistan Mountains. The honey was placed in contact with the socket wound. Then the parents and children were asked to keep the gauze piece in place for 45 minutes.
Main outcome variables
wound size
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181008041269N1
Registration date:2018-11-05, 1397/08/14
Registration timing:retrospective
Last update:2018-11-05, 1397/08/14
Update count:0
Registration date
2018-11-05, 1397/08/14
Registrant information
Name
Saeedeh Mokhtari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4279 4200
Email address
sa.mokhtari@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
2017-03-21, 1396/01/01
Actual recruitment end date
2017-06-22, 1396/04/01
Trial completion date
2017-07-23, 1396/05/01
Scientific title
Evaluation of the Effect of Honey on the Healing of Tooth Extraction Wounds in 4-6-year-old Children
Public title
effect of honey on wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
no history of systemic conditions, use of medications and allergy to honey
not repeatedly used honey during the previous 6-month period.
need removal of one deciduous molar tooth,
Exclusion criteria:
Any systemic conditions that prevent dental treatment under local anesthesia
A history of allergy to the substance of anesthesia and sulfate and honey
Age
From 4 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Actual sample size reached:
76
Randomization (investigator's opinion)
Randomized
Randomization description
simple
After reviewing the inclusion and exclusion criteria, each patient randomly using simple randomization and individual (open envelope sealed) divided into two groups of treated with honey and without honey
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of dental school of Tehran university of medical sciences
Street address
North Kargar St.
City
Tehran
Province
Tehran
Postal code
1439955934
Approval date
2017-03-12, 1395/12/22
Ethics committee reference number
IR.TUMS.VCR.REC.1395.1951
Health conditions studied
1
Description of health condition studied
wound healing
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
wound size decrease
Timepoint
seven days
Method of measurement
using digital caliper
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: applying a piece of gauze moistened with normal saline solution and a thin layer (1mm thick) fresh Kordestan honey for 45 min
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Pediatric, Dentistry Dental school,Tehran university of medical sciences
Full name of responsible person
Saeedeh Mokhtari
Street address
North Kargar
City
Tehran
Province
Tehran
Postal code
1439955934
Phone
+98 21 4279 0000
Email
sa.mokhtari@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
دکتر مرضیه علی خاصی
Street address
amirabad st.
City
tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 4279 0000
Email
smokhtari@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Saeedeh Mokhtari
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
North Kargar
City
Tehran
Province
Tehran
Postal code
1439955934
Phone
+98 21 4279 0000
Email
sa.mokhtari@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Saeedeh Mokhtari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
North kargar
City
Tehran
Province
Tehran
Postal code
1439955934
Phone
+98 21 4279 0000
Fax
Email
Sa.mokhtari@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Saeedeh Mokhtari
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
North Kargar
City
Tehran
Province
Tehran
Postal code
1439955934
Phone
+98 42790000
Email
sa.mokhtari@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD