Comparison of bacterial contamination and complications after impacted wisdom tooth surgery with sterile and clean gloves
Design
Clinical trial, randomized, parallel group trial with single blinded outcome assesment
Settings and conduct
This study will be performed on patients referred for wisdom tooth surgery in the mandible to the clinic of the School of Dentistry and the private office of the maxillofacial surgeon in Bojnourd. The study will be performed as single blind and the patient is unaware. Samples are taken from all surfaces of gloves before and after surgery to compare bacterial contamination with sterile swabs. Also, immediately after the extraction of the tooth,swab is immersed in sockrt and the samples taken are transferred to the laboratory. One week later, the patient is referred again and evaluated for complications and recorded in the checklist.
Participants/Inclusion and exclusion criteria
People aged 18-35 who needed widsom tooth surgery compeletly hidden in mandible
All patients are non-smokers and non-alcoholis.All patient should be in ASA1 group.Patient without systemic disease and immunodeficiency
Patients who are taking antibiotics for the current infection or need antibiotic prophylaxis before
surgery.Patients who surgery lasts more than 30 minutes.Patient with uncpontrolled diabetes or bleeding disorders.Paatients receiving steroid therapy.Patients with a history of head and neck radiotherapy.Existence of deep caries and pericronitis.
.
Intervention groups
The 40 patients who were included in the study were randomly divided into two groups, one using sterile gloves and the other using clean gloves for the surgeon and his assistant.
Comparison of bacterial contamination and complications after impacted wisdom tooth surgery using sterile gloves and clean gloves
Public title
Comparison of complications of wisdom teeth with surgical and clean gloves
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
People aged 18-35 who needed widsom tooth surgery compeletly hidden in mandible
All patients are non-smokers and non-alcoholis
All patient should be in ASA1 group.
Patient without systemic disease and immunodeficiency
Exclusion criteria:
Patients who are taking antibiotics for the current infection or need antibiotic prophylaxis before surgery.
Patients who surgery lasts more than 30 minutes.
Patient with uncpontrolled diabetes or bleeding disorders.
Paatients receiving steroid therapy.
Patients with a history of head and neck radiotherapy.
Existence of deep caries and the need for root canal thrapy in other teeth and other inflammatory problems such as pericronitis.
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Using limited randomization and the method of random allocation law due to the tendency to choose equal sample size in two groups; the researcher involved based on the sample size of 40 in this study: in the randomization process, 20 sheets with A and 20 The sheet with the number B written on it will be placed in a lottery container and then the papers will be randomly removed from the lottery container and a random sequence will be recorded. To ensure concealment, the names of the selected groups in the envelopes They will be coded according to a random sequence (the researcher will make sure that the envelopes are sealed and similar in appearance) and to ensure compliance with the allocation process to prevent or reduce possible bias, the person involved in creating a random program It will be a separate project from other researchers.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the subjectivity of some of the measured complications (pain) of the study, we do it as single blind so that only at the beginning of the study and informed consent to the patient will be told the procedure and whether he is in the group of sterile or non-sterile gloves The patient will remain unaware
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Secondary trial Id
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of North khorasan University of Medical Sciences
Street address
N17, Zafar Ave, Baharan Ave, Faramarz Abbasi Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9197855711
Approval date
2021-05-01, 1400/02/11
Ethics committee reference number
IR.NKUMS.REC.1400.008
Health conditions studied
1
Description of health condition studied
Wisdom tooth surgery completely hidden in mandible with sterile and clean glove
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Fever
Timepoint
One week after lower wisdom tooth surgery
Method of measurement
One week after surgery, all complications such as fever above 37.5 ° C with a thermometer.
2
Description
Pain with a score of 0-10 by the patient
Timepoint
One week after lower wisdom tooth surgery
Method of measurement
Postoperative pain with a score of 0-10 by the patient
3
Description
Dry socket
Timepoint
One week after lower wisdom tooth surgery
Method of measurement
Persistent throbbing pain
4
Description
Acute socket inflammation
Timepoint
One week after lower wisdom tooth surgery
Method of measurement
Acute socket inflammation without pus and systemic fever
5
Description
Acute socket infection,
Timepoint
One week after lower wisdom tooth surgery
Method of measurement
Acute socket infection is associated with pus and systemic fever
6
Description
Colony- forming unit
Timepoint
One week after lower wisdom tooth surgery
Method of measurement
The number of colony units is calculated by counting the number of colonies formed on the culture medium
Secondary outcomes
1
Description
Swelling
Timepoint
One week after surgery
Method of measurement
Swelling of the gums at the surgical site, which may appear asymmetrically on the face.
2
Description
Pus and redness in gingiva
Timepoint
One week after surgery
Method of measurement
Removal of pus from the surgical site and redness of the gums, which can be seen one week after surgery.
Intervention groups
1
Description
Intervention group: Use of sterile maxter gloves made in Malaysia for mandibular impact wisdom tooth surgery
Category
Other
2
Description
Intervention group: Using op-perfect clean gloves made in Iran for mandibular impact wisdom tooth surgery
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
North Khorasan School of Dentistry
Full name of responsible person
Oghazian Sabah
Street address
Bojnourd, Arkan Road, next to Imam Hassan Hospital
City
Bojnourd
Province
North Khorasan
Postal code
9417694735
Phone
+98 58 3229 6764
Email
m.anbarestani1374@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Amani Amir
Street address
Bojnourd - Shahriar St. - Above Imam Ali Hospital - Faculty of Medicine - Vice Chancellor for Research and Technology
City
Bojnourd
Province
North Khorasan
Postal code
9417694780
Phone
+98 58 3229 6764
Email
A.Amani@nkums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bojnourd 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
Bojnourd University of Medical Sciences
Full name of responsible person
Oghazian Sabah
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Arkan Road, next to Imam Hassan Hospital, School of Dentistry
City
Bojnourd
Province
North Khorasan
Postal code
9417694735
Phone
+98 58 3229 6764
Email
sabah.oghazian1@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Oghazian Sabah
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Arkan Road, next to Imam Hassan Hospital, School of Dentistry
City
Bojnourd
Province
North Khorasan
Postal code
9417694735
Phone
+98 58 3229 6764
Email
sabah.oghazian1@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Oghazian Sabah
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Arkan Road, next to Imam Hassan Hospital, School of Dentistry
City
Bojnourd
Province
North Khorasan
Postal code
9417694735
Phone
+98 58 3229 6764
Email
sabah.oghazian1@gmail.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