The effect of direct irrigation of the third molar surgery site in comparison with rinsing the mouth after surgery in reducing surgical complications including pain, swelling, infection and alveolar osteitis in case of bilateral wisdom teeth in the mandible
Reduction of surgical complications including pain, swelling, infection and alveolar osteitis and increasing patient ease after impacted wisdom tooth surgery
Design
Clinical trial with control group, with parallel groups, with no blinding, randomized, phase 2 on 20 patients. In each patient, allocating to intervention or control group is determined by throwing a coin
Settings and conduct
Implantable surgery is performed in Ahvaz Oral and Maxillofacial Surgery Department affiliated to Ahvaz Dental School and no blinding has been performed
Participants/Inclusion and exclusion criteria
Inclusion criteria: Systemically healthy patient; Obtain informed consent; Patients whose wisdom tooth surgery is indicated. Non-inclusion criterion: taking any antibiotics, anti-inflammatory or analgesic drugs in the last week before surgery
Intervention groups
The intervention group rinsed the site of the operated wisdom tooth with a syringe containing 0.2% chlorhexidine, but the control group rinsed their mouth with 0.2% chlorhexidine after wisdom tooth surgery
Main outcome variables
Pain; swelling; infection; alveolar osteitis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201231049900N1
Registration date:2021-07-14, 1400/04/23
Registration timing:retrospective
Last update:2021-07-14, 1400/04/23
Update count:0
Registration date
2021-07-14, 1400/04/23
Registrant information
Name
Fatemeh Khosravi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3354 6125
Email address
www.khosravi.fatemeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-19, 1399/10/30
Expected recruitment end date
2021-03-17, 1399/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of direct irrigation of the third molar surgery site in comparison with rinsing the mouth after surgery in reducing surgical complications including pain, swelling, infection and alveolar osteitis in case of bilateral wisdom teeth in the mandible
Public title
Review the effect of direct irrigation after wisdom tooth surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All patients for whom bilateral mandibular impact wisdom tooth surgery is indicated
The patient is systemically healthy
obtain informed consent
Exclusion criteria:
Taking any anti inflammatory or analgesics drugs or antibiotics one week before surgery
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
Study of two mandibular third molars in one patient
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly selected individually and then identified in each patient, allocating to intervention or control group is determined by throwing a coinsurgery.
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 Ahvaz University of Medical Sciences
Street address
Esfand Ave, Golestan road, Ahvaz Town
City
Ahvaz
Province
Khouzestan
Postal code
6135853415
Approval date
2020-12-27, 1399/10/07
Ethics committee reference number
IR.AJUMS.REC.1399.779
Health conditions studied
1
Description of health condition studied
The wisdom tooth surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The amount of pain after wisdom tooth surgery
Timepoint
One week after surgery
Method of measurement
Pain measurement based on Visual Analogue Scale
2
Description
The amount of swelling after wisdom tooth surgery
Timepoint
One week after surgery
Method of measurement
Based on three hypothetical plans (occlusal plan, the hypothepical lines is drawn 2cm forward and 2cm backward from the line perpendicular to the mandibular gonial notch plane)
3
Description
Infection occurrence one week after wisdom tooth surgery
Timepoint
One week after surgery
Method of measurement
Based on the observation of fever, sore throat and lymphadenopathy
4
Description
Alveolar osteitis occurrence after impacted wisdom tooth surgery
Timepoint
One week after surgery
Method of measurement
Based on the observation of empty dental socket without blood clots
Secondary outcomes
empty
Intervention groups
1
Description
Control group: The patient rinses his/her mouth with 0.2% chlorhexidine mouthwash (Iran najo co.) after 48 hours after surgery three times a day
Category
Treatment - Drugs
2
Description
Intervention group: the patient rinses the surgical site three times a day with a syringe containing chlorhexidine 0.2% (Iran najo co.) after 48 hours after surgery for one week
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Surgery, School of Dentistry, Ahwaz Jundishapur University
Full name of responsible person
Milad Alikazemi
Street address
Dentistry Faculty, Dey Ave, Golestan road, Ahwaz Town
City
Ahwaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3320 5168
Email
alikazemi_m@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Milad Alikazemi
Street address
Dentistry Faculty, Dey Ave, Golestan road, Ahwaz Town
City
Ahwaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3320 5168
Email
Miladalikazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Milad Alikazemi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No 34, Eastern Shahrivar street, Kianpars road, Ahwaz Town
City
Ahwaz
Province
Khouzestan
Postal code
6155694897
Phone
+98 61 3333 1799
Email
Miladalikazemi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Milad Alikazemi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No 34, Eastern Shahrivar street, Kianpars road, Ahwaz Town
City
Ahwaz
Province
Khouzestan
Postal code
6155694897
Phone
+98 61 3333 1799
Email
Miladalikazemi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Milad Alikazemi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No 34, Eastern Shahrivar street, Kianpars road, Ahwaz Town
City
Ahwaz
Province
Khouzestan
Postal code
6155694897
Phone
+98 61 3333 1799
Email
Miladalikazemi@gmail.com
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