Preparation and in-vitro and in-vivo evaluation of a lipid-liquid crystal gel dressing containing eugenol and iodoform aim to treatment of alveolar osteitis
Our goal is to prepare and evaluate a lipid liquid crystal base dressing gel that contains eugenol as an analgesic and iodoform as an antiseptic, with wound healing capacity. The formulation can satisfactorily be used as a substitute for Alvogyl paste (which is not available in the Iranian market) which creates artificial blood clot to prevent re-bleeding.
Design
A parallel, triple-blind, randomized, controlled, phase 3 clinical trial on 60 patients. Balloting was used for randomization.
Settings and conduct
Recording the patient's information upon entering the Mashhad Dentistry School; Applying the medicine in the dental socket based on the experiment or control group; Recording the pain level according to VAS in specific time intervals and repeating if necessary.
Triple-blind study
Test or control dressing is placed in the patient's socket according to the randomization.
Test and control dressing are delivered to the clinical caregiver in similar containers.
The data analyzer receives patient information based on the code.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Age between 18 to 60 years old.
2. Patients suffering from dry socket who refer to Mashhad dentistry school.
3. Signing the informed consent.
exclusion criteria:
1. Smoking
2. Pregnancy and breastfeeding
3. History of allergy to foods and drugs
4. Suffering from systemic diseases
5. Any active infective disease
6. Taking medications that interact with the healing process
Intervention groups
1. Control group: applying a sufficient amount of alveogel in the tooth socket.
2. Intervention group: applying a sufficient amount of liquid crystal gel dressing in the tooth socket.
Main outcome variables
1. Measuring patients' pain upon admission (according to VAS) and examining the intensity of pain after applying each type of dressing
2. Checking the number of times the dressing is used
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221027056320N1
Registration date:2022-12-02, 1401/09/11
Registration timing:registered_while_recruiting
Last update:2022-12-02, 1401/09/11
Update count:0
Registration date
2022-12-02, 1401/09/11
Registrant information
Name
Amirhossein Chavoshi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3890 9880
Email address
chavoshia961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-19, 1401/08/28
Expected recruitment end date
2023-06-21, 1402/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preparation and in-vitro and in-vivo evaluation of a lipid-liquid crystal gel dressing containing eugenol and iodoform aim to treatment of alveolar osteitis
Public title
Preparation and evaluation of a new dressing aim to treat dry socket
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Participants' age should be between 18 to 60 years old.
Patients suffering from dry socket following a tooth extraction who refer to Mashhad dentistry school.
Participants should sign the informed consent.
Exclusion criteria:
Smoking or addiction
Pregnancy and breastfeeding
History of allergy to foods and drugs
Suffering from systemic diseases
Active infective disease (such as hepatitis , AIDS ,TB)
Taking medications which interact with healing process (such as corticosteroids , immunosuppressors , anticancer drugs , anticoagulants)
Age under 18 or above 60 years old
History of radiotherapy of head and neck region.
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
For the required number of samples, identical envelopes are prepared, half of them are marked as group one and the other half as group two, the envelopes are sealed, patients are randomly assigned to one of the two groups by choosing an envelope.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The participant randomly chooses one of the envelopes and based on the selected code, one of the drugs (test and control) is placed in the patient's socket. Since the patient does not know which drug is the test and which is the control, and it is not posible to see the drug inside the socket, the study is blind for the participant.
The clinical caregiver is selected among the nurses. The test and control drugs are delivered to them in similar containers, and they will not know which drug is the control or the test.
The outcome evaluator and data analyzer receive patient information based on the code and will not know which code is related to the control drug or the test drug.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics committee of Mashhad university of medical sciences
Street address
Research and technology vice-chancellor, Qoreishi building, next to Hoveizeh cinema, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2022-04-30, 1401/02/10
Ethics committee reference number
IR.MUMS.REC.1401.097
Health conditions studied
1
Description of health condition studied
alveolar osteitis (dry socket)
ICD-10 code
K10.3
ICD-10 code description
Alveolar osteitis , Dry socket
Primary outcomes
1
Description
Measuring patients' pain upon admission (according to VAS) and examining the intensity of pain after applying each type of dressing
Timepoint
At 30, 60 minutes and 6, 12, 24, 48, 72 hours and 7 days after application and it continues on a daily basis, until the patient has pain.
Method of measurement
Questionnaire designed based on Visual Analog Scale (VAS)
2
Description
Checking the number of times the dressing is used
Timepoint
After the complete relief of pain and at the end of the follow-up
Method of measurement
Recording the frequency of dressing use in Excel by the researcher
Secondary outcomes
1
Description
Checking the number of Analgesic used for each patient
Timepoint
After the complete relief of pain and at the end of the follow-up
Method of measurement
Asking the patient and recording in Excel by the researcher
Intervention groups
1
Description
Control group: applying sufficient amount of alveogel manufactured by the Turkish company "Kalsin" in the tooth socket so that it fills the socket and repeating it every 24 hours in case of pain and upon the request of the patient until the complete pain relief.
Category
Treatment - Drugs
2
Description
Intervention group: applying sufficient amount of liquid crystal gel dressing, prepared in Mashhad Faculty of Pharmacy, in the tooth socket so that it fills the socket and repeating it every 24 hours in case of pain and upon the patient's request until the complete pain relief.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Surgery, Mashhad Faculty of Dentistry
Full name of responsible person
Mahdi Gholami
Street address
Faculty of dentistry, in front of Mellat park, at the beginning of Vakil Abad blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
ShirzadeA@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour Mobarhan
Street address
Research and technology vice chancellor, Qoreishi building, next to Hoveizeh cinema, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Fax
+98 51 3843 0249
Email
GhayourM@mums.ac.ir
Web page address
https://v-research.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Amirhossein Chavoshi
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Unit 4, No. 5, at the Hekmat sq. corner, Piroozi Blvd, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9178843100
Phone
+98 51 3890 9880
Fax
Email
chavoshia961@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amirhossein Chavoshi
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Unit 4, No. 5, at the Hekmat sq. corner, Piroozi Blvd, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9178843100
Phone
+98 51 3890 9880
Fax
Email
chavoshia961@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amirhossein Chavoshi
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Unit 4, No. 5, at the Hekmat sq. corner, Piroozi Blvd, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9178843100
Phone
+98 51 3890 9880
Fax
Email
chavoshia961@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All personal data of study participants can be shared after anonymization.
When the data will become available and for how long
Beginning of the access period, 6 months after the publication of the results.
To whom data/document is available
All applicants in academic and non-academic sectors can apply to receive data after authentication..
Under which criteria data/document could be used
For use in the academic sector, the source of the data must be mentioned and the copyright must be respected. If it is used in the industrial sector leading to product production, the royalties of the researchers involved in the study should be included.
From where data/document is obtainable
To receive data, send an email containing your introduction and the reason for needing data to the following address:
Amirhossein Chavoshi
The first researcher of the study
ahch1378@gmail.com
What processes are involved for a request to access data/document
1. Sending an email containing specifications and reasons for the need for data
2. Completing the sent questionnaire form
3. Authentication and consent of all researchers to release data
4. Sending data to the applicant