The aim of this study is to evaluate the topical application of royal jelly on wound healing process of extracted teeth of maxilla and mandible.
Design
Clinical trial with parallel groups, triple blinded and randomized. For randomization Random allocation software will be used. Groups are formed as control of maxilla and mandible, study of maxilla and mandible.
Settings and conduct
The study will be held at oral and maxillofacial surgery section of isfahan university of medical sciences. After tooth extraction and rinsing the socket with sterile normal saline, in control groups gelatamp smeared with sterile normal saline will be applied on the fresh tooth socket. In study groups gelatamp smeared with royal jelly which is freeze dried and diluted to 5% in sterile normal saline will be applied on the fresh tooth socket. In all patients study variables will be evaluated and recorded in study and control groups in two periods (after tooth extraction and 1 week later).
Patients, dentist recording variables and statistics analyzer won't be aware of patient's groups.
Participants/Inclusion and exclusion criteria
Patients referred for extraction of not impacted molar teeth in maxilla or mandible, being at least 18 years old and healthy enter the study.
In case of pregnancy, using medication or mouthwash, need of antibiotic prophylaxis, allergy to honey, addiction or regional infection patients won't enter the study.
Intervention groups
In control groups gelatamp smeared with sterile normal saline will be applied on the fresh tooth socket. In study groups gelatamp smeard with royal jelly which is freeze dried and diluted to 5% in sterile normal saline will be applied on the fresh tooth socket.
Main outcome variables
The variables of the study include the size of the wound, bleeding after touching, the appearance of pus, the appearance of granulation tissue, the color of the tissue and pain.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221127056634N1
Registration date:2023-01-23, 1401/11/03
Registration timing:prospective
Last update:2023-01-23, 1401/11/03
Update count:0
Registration date
2023-01-23, 1401/11/03
Registrant information
Name
Ali Mazdak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3267 4556
Email address
alimazdak@res.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-04, 1401/11/15
Expected recruitment end date
2023-04-21, 1402/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of royal jelly on post extraction socket healing ; A randomized triple blind clinical trial
Public title
Evaluation of the effect of royal jelly on post extraction socket healing
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who refer for extraction of non-impacted molar teeth
At least 18 years old
Without any systemic disease
Exclusion criteria:
History of the long-term use of non-steroidal anti-inflammatory drugs or corticosteroids or bisphosphonates or chemotherapy drugs or immunosuppressive drugs
The need for antibiotic prophylaxis before tooth extraction
Known allergy to honey or its products
Continuous use of royal jelly in the last 6 months
Severe untreated periodontal disease
Being under dental treatment
Compulsion to use any type of mouthwash or any type of medicine from the time of tooth extraction until ten days later
Smoking
Addiction to alcohol, drugs, medicine or a certain substance
Acute infection or presence of pus in the tooth area
Pregnancy
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, in order to balance the number of patients assigned to each of the two study groups, the permuted block randomization method is used. Also In order not to reveal the last allocation in each block, the size of the blocks is chosen randomly. For this purpose, random blocks with sizes of 4, 6, or 8 are used. This information is given to the random allocation software and the classification of patients is determined. Since all the patients of this study are not selected at the same time and also in order to observe the blinding process as much as possible, before starting the study, 52 empty files are numbered from 1 to 52 and one file is randomly selected for each patient. Based on the patient's file number and its match with the output of the random allocation software, the patient's group is determined. In order to blindness, the patients will not know about the group in which they are placed.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In order to blindness, the patients will not know about the group (intervention or control) in which they are placed.
After tooth extraction by first dentist, the variables are evaluated by second dentist (who has no knowledge of the patient's study group for the purpose of blindness).
The statistician who analyzes the results will not know about the patient's study groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Faculty of Dentistry, Isfahan University of Medical Sciences, Hezarjerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2022-11-07, 1401/08/16
Ethics committee reference number
IR.MUI.RESEARCH.REC.1401.239
Health conditions studied
1
Description of health condition studied
Post extraction socket healing
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
wound size of tooth socket
Timepoint
Measurement of wound size at the beginning of the study (immediately after tooth extraction and washing the socket with normal saline) and seven days later.
Method of measurement
Using a caliper (ae JUYA instruments, Istanbul, Turkey)
2
Description
Bleeding after palpation of the tooth socket
Timepoint
Examination of bleeding after palpation at the beginning of the study (immediately after tooth extraction and washing the socket with normal saline) and seven days later.
Method of measurement
Visually
3
Description
The presence or absence of pus in the tooth socket
Timepoint
At the beginning of the study (immediately after tooth extraction and washing the socket with normal saline) and seven days later.
Method of measurement
Visually
4
Description
Presence or absence of granulation tissue in the tooth socket
Timepoint
At the beginning of the study (immediately after tooth extraction and washing the socket with normal saline) and seven days later.
Method of measurement
Visually
5
Description
Tissue color of the tooth socket
Timepoint
At the beginning of the study (immediately after tooth extraction and washing the socket with normal saline) and seven days later.
Method of measurement
Visually
6
Description
Amount of pain
Timepoint
At the beginning of the study (immediately after tooth extraction and washing the socket with normal saline) and seven days later.
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, after tooth extraction and washing the tooth socket with injectable sterile normal saline, pure royal jelly powder (prepared from the pharmaceutical department of Amin Pharmaceutical Co. Isfahan, Iran) which is sterilized through gamma radiation and will be going through Freeze drying process (the inside water will be removed and it becomes a powder); is mixed to a concentration of five percent in sterile normal saline (Sodium Chloride 0.9% for injection, Iranian Parenteral and Pharmaceutical Co. Tehran, Iran). Then the gelatamp smeared with this mixture will be applied on the tooth socket.
Category
Treatment - Drugs
2
Description
Control group: In this group, after tooth extraction and washing the tooth socket with injectable sterile normal saline, gelatamp smeared with sterile normal saline (Sodium Chloride 0.9% for injection, Iranian Parenteral and Pharmaceutical Co. Tehran, Iran) will be applied on the tooth socket.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Isfahan University of Medical sciences
Full name of responsible person
Ali Mazdak
Street address
Hezarjerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 5565
Email
alimazdak@res.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Asgari
Street address
Hezarjerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Email
askari@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Ali Mazdak
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Hezarjerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
alimazdak@res.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Mazdak
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Hezarjerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
alimazdak@res.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Peiman Mazaheri
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Hezarjerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
peimanarman1378@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Some of the data including information about main outcome and study variables after making study cases (patients) not identifiable, will be shared.
When the data will become available and for how long
Beginning of accessibility period is 6 months after publishing the article.
To whom data/document is available
Researchers working in academic and scientific institutes and professionals occupied in pharmaceutics departments of pharmacy companies and they have an approved research plan that has a ethical approval.
Under which criteria data/document could be used
If the research plan is to be carried out in the continuation of the current study or in the completion of this study, it is possible to use the data
From where data/document is obtainable
For getting access to data, requests should be sent to study administrators Ali Mazdak or Peiman Mazaheri to email addresses of alimazdak@res.mui.ac.ir or peimanarman1378@gmail.com .
What processes are involved for a request to access data/document
After checking the identity information of requester and the correctness of the mentioned ethical approval code and checking the job or academic position data will be shared.