Comparison the effect of aloe vera-containing gel-foam in preventing the occurrence of dry socket in patients requiring wisdom tooth extraction in the mandible
Evaluation of the effect of aloe vera containing gel-foams in preventing dry socket and controlling the bleeding
Design
Clinical trial with control group, with parallel groups, without blinding and not randomized, phase 3 per 100 patients
Settings and conduct
This study will be performed in the surgical department of Tabriz Dental School. 100 patients who refer for their wisdom tooth surgery (two wisdom teeth with similar conditions in the mandible) will be selected. One of the two wisdom teeth of the patient as a test group in which after extracting the aloe vera-containing gel-foam will be placed and the other teeth will be considered as a control and will removing normally without placing any substance. All patients will refer 3 and 7 days after surgery and will be evaluated for occurrence of dry socket.
Participants/Inclusion and exclusion criteria
100 men or women aged 18 to 35 with two wisdom teeth with similar conditions in the mandible without systemic or bone disease
Intervention groups
Intervention group (control group): One of the two wisdom teeth of the patient as a test group in which after extracting the aloe vera-containing gel-foam will be placed and the other teeth will be considered as a control and will removing normally without placing any substance.
Main outcome variables
Main outcome variable: The occurrence of dry socket
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200919048756N3
Registration date:2021-01-26, 1399/11/07
Registration timing:prospective
Last update:2021-01-26, 1399/11/07
Update count:0
Registration date
2021-01-26, 1399/11/07
Registrant information
Name
Solmaz Maleki Dizaj
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 3161
Email address
maleki.s.89@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-04, 1400/01/15
Expected recruitment end date
2022-03-06, 1400/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of aloe vera-containing gel-foam in preventing the occurrence of dry socket in patients requiring wisdom tooth extraction in the mandible
Public title
The effect of aloe vera-containing gel-foam in dry socket prevention
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having two wisdom teeth with similar position in the mandible
Exclusion criteria:
Having systemic and skeletal disease, smoking, using any types of drugs, pregnant women
Age
From 18 years old to 35 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
More than 1 sample in each individual
Number of samples in each individual:
2
On the control side, the teeth are removed normally and on the opposite side (test), after the tooth is extracted, the aloe vera containing gelfoams will be inserted.
Randomization (investigator's opinion)
N/A
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
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Daneshgah Ave, Golgasht Blvd, Tabriz.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2020-07-14, 1399/04/24
Ethics committee reference number
IR.TBZMED.REC.1399.865
Health conditions studied
1
Description of health condition studied
Occurrence of dry socket after wisdom tooth extraction
ICD-10 code
M27.3
ICD-10 code description
Alveolitis of jaws
Primary outcomes
1
Description
Occurrence of dry socket
Timepoint
3 and 7 days after tooth extraction
Method of measurement
Asking the patients about the pain, observing the dental extraction site to check for incidence or absence of dry socket
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Aloe vera powder-containing gel-foam (8 mg)
Category
Treatment - Drugs
2
Description
Control group: Routine treatment
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Tabriz University of Medical Sci
Full name of responsible person
Mohammad Ali Ghavimi
Street address
Tabriz University of Medical Sciences, Daneshgah Ave, Golgasht Blvd, Tabriz.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 3161
Email
m_ghavimi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Sameie
Street address
Tabriz University of Medical Sciences, Daneshgah Ave, Golgasht Blvd, Tabriz.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3336 3767
Email
research-vice@tbzmed.ac.ir
Web page address
https://researchvice.tbzmed.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Ali Ghavimi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz University of Medical Sciences, Daneshgah Ave, Golgasht Blvd, Tabriz.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 3161
Email
m_ghavimi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Solmaz Maleki Dizaj
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Nanotechnology
Street address
Tabriz University of Medical Sciences, Daneshgah Ave, Golgasht Blvd, Tabriz.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 3161
Email
maleki.s.89@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Solmaz Maleki Dizaj
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Nanotechnology
Street address
Tabriz University of Medical Sciences, Daneshgah Ave, Golgasht Blvd, Tabriz.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 3161
Fax
Email
maleki.s.89@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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
It will be published as a Persian and English article.
When the data will become available and for how long
From the time of publication of the articles onwards.
To whom data/document is available
public
Under which criteria data/document could be used
For use in studies with detailed citations.
From where data/document is obtainable
Dr,. Solmaz Maleki
What processes are involved for a request to access data/document