Incidence of dry socket with and without use of porous gelfum containing curcumin following extraction of impacted wisdom teeth
Design
The clinical trial has a control group, phase zero, with parallel intervention groups, randomized, without blinding, and random sampling method. 38 patients The patients were randomly selected and in each patient the selection of one side tooth as a control or test will be by simple randomization using coins in the form of taps/lines.
Settings and conduct
Patients with two wisdom teeth embedded in both sides of the mouth referred to the surgical department of the dental school are included in the study. The extraction of both teeth in patients will be performed by a surgeon in the same conditions. One side of the tooth (control tooth) is removed normally and the other side (test) is inserted into the cavity of the antimicrobial porous gelatin jelly after removing the tooth. Finally, 3 days and 7 days later for examination for incidence. They are examined silently and the VAS method is used to assess pain.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- Having two wisdom teeth with similar position of mesiangular in the mandible 2- Age 18 to 35 years old 3_Non-addiction to drugs and smoking 4_No systemic and skeletal diseases 4- No non-pregnancy of women Exclusion criteria: 1- No patient to refer to the other side for extraction of teeth on the other side and subsequent evaluations 2- Smoking and drugs after the start of the study and during it 3- Medical treatment 4- Consumption of medicine 5_Sensitivity to study therapies
Intervention groups
Control group: Teeth are extracted normally. Experimental group: Insertion of porous antimicrobial gelatin gelfum after tooth extraction
Main outcome variables
Occurrence of silent drift (pain, unpleasant odor and lack of proper clot formation in the extracted tooth cavity)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130710013938N5
Registration date:2021-08-10, 1400/05/19
Registration timing:registered_while_recruiting
Last update:2021-08-10, 1400/05/19
Update count:0
Registration date
2021-08-10, 1400/05/19
Registrant information
Name
Mohamadali Ghavimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 5968
Email address
ghavimim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-02, 1400/04/11
Expected recruitment end date
2021-11-02, 1400/08/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Incidence of the dry socket with and without the use of porous gelfum containing curcumin following extraction of impacted wisdom teeth
Public title
The effect of using a new material (porous gelfum) on the tooth cavity when extracting impacted wisdom teeth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having two wisdom teeth with the similar mesioangular position in the mandible
No addiction to drugs and smoking
Lack of systemic and bone diseases
Women are not pregnant
Age 18 to 35 years
Exclusion criteria:
Failure to refer the patient for extraction of the other side tooth and subsequent evaluations
Smoking and drug use after and during the study
Undergoing medical treatment
taking medication
Sensitivity to study therapies
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
38
More than 1 sample in each individual
Number of samples in each individual:
2
One side tooth will be considered as a control and the opposite side tooth will be considered as a test.
Randomization (investigator's opinion)
Randomized
Randomization description
Thirty-eight patients who refer to the Department of Surgery of the School of Dentistry for their wisdom tooth surgery agree to carry out this research project and complete informed consent and form our study community. Patients are randomly selected and in each patient, the selection of one side tooth as control or test will be by simple randomization using coins in the form of taps/lines. Each patient who enters the study will be assigned a code from 1 to 38.
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 committe of Tabriz University of Medical Sciences
Street address
3rd floor, No2 Centeral Building , Tabriz University of Medical Sciences, ,Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2021-02-22, 1399/12/04
Ethics committee reference number
IR.TBZMED.REC.1399.1097
Health conditions studied
1
Description of health condition studied
Impacted wisdom tooth
ICD-10 code
K01.1
ICD-10 code description
Impacted teeth
Primary outcomes
1
Description
Occurrence of silent drift (pain, unpleasant odor and lack of proper clot formation in the extracted tooth cavity)
Timepoint
3 days and 7 days later
Method of measurement
Patients are given questionnaires that indicate their pain on the first, second, and ... days until the 7th day in the form of numbers from 1 to 10. Clinical examination of the patient and completion of information forms are used to collect information and the Visual Analogue Scale method is used to assess pain.
Secondary outcomes
empty
Intervention groups
1
Description
Control group: All patients were randomly selected and after completing the questionnaire, they were approved by at least two professors of the surgical department. Before the operation, chlorhexidine mouthwash was prescribed and gelofen was administered to them. Extraction of both teeth will be performed by a surgeon under the same conditions. To anesthetize patients, 3 carpol lidocaine containing epinephrine 1 in 80,000 was used and performed with lower alveolar block and long buccal technique. In patients in this group, teeth are extracted normally. To unify the patients, if the time difference between the two operations (from the beginning of the operation to the moment of the last suture) is more than 10 minutes, the patient will be excluded from the study. Silent examination (pain, unpleasant odor and lack of proper clot formation in the extracted tooth cavity) are examined; Patients are given questionnaires that indicate their pain on the first, second and ... days until the 7th day in the form of numbers from 1 to 10. Clinical examination of the patient and completion of information forms are used to collect information and VAS method is used to assess pain.
Category
Treatment - Drugs
2
Description
Intervention group: All patients were randomly selected and after completing the questionnaire, they were approved by at least two professors of the surgical department. Before the operation, chlorhexidine mouthwash was prescribed and gelofen was administered to them. Extraction of both teeth will be performed by a surgeon under the same conditions. To anesthetize patients, 3 carpol lidocaine containing epinephrine 1 in 80,000 was used and performed with lower alveolar block and long buccal technique. After tooth extraction, an antimicrobial porous gelatin gel (containing curcumin nanoparticles) is placed inside the cavity. The prepared gelfomes were cut into 1: 1 by 1 cm dimensions and sterilized by gamma rays. Zelfum has a spongy structure with pores of 200 nm and a loading percentage of 96% curcumin and a slow release pattern of curcumin. To unify the patients, if the time difference between the two operations (from the beginning of the operation to the moment of the last suture) is more than 10 minutes, the patient will be excluded from the study. Silent examination (pain, unpleasant odor and lack of proper clot formation in the extracted tooth cavity) are examined; Patients are given questionnaires that indicate their pain on the first, second and ... days until the 7th day in the form of numbers from 1 to 10. Clinical examination of the patient and completion of information forms are used to collect information and VAS method is used to assess pain.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences
Full name of responsible person
Mohammadali Ghavimi
Street address
3rd floor, No 2 Central Building , Tabriz University of Medical Sciences, Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5921
Email
Ghavimim@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Prof. Mohammad Samiei
Street address
3rd floor, No 2 Central Building , Tabriz University of Medical Sciences, Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5921
Email
Ghavimim@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
Private
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
Mohammadali Ghavimi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Dentistry
Street address
3rd floor, No 2 Central Building , Tabriz University of Medical Sciences, Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5921
Email
Ghavimim@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammadali Ghavimi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Dentistry
Street address
3rd floor, No 2 Central Building , Tabriz University of Medical Sciences, Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5921
Email
Ghavimim@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammadali Ghavimi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Dentistry
Street address
3rd floor, No 2 Central Building , Tabriz University of Medical Sciences, Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5921
Email
Ghavimim@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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