Comparison of chlorhexidine gel , hydrogen peroxide gel and povidone iodine gel effects on the symptoms of dental socket (pain and swelling) following the wisdom mandibular teeth surgery.
Comparison of the effect of chlorhexidine gel, hydrogen peroxide gel and povidone iodine gel on pain and swelling after mandibular wisdom tooth surgery
Design
112 people with wisdom teeth will be selected for clinical trials with the Inclusion criteria that require dental extraction surgery.from All patients are asked to read and sign the Consent Consent.Patients will be randomly divided to four groups with 28 members.control patients (normal saline user), chlorine hexidine gel consumer group, povidone iodine gel consumer group, and hydrogen peroxide gel consumer group.The main anesthesia technique used will be the alveolar inferior nerve block and the longe buccal nerve block, which will also use the infiltration anesthesia method to complete the anesthesia of the target area.After extracting the wisdom tooth and rinsing with 40 ml of sterile serum, three groups of 28 people were filled with the desired gels and then the desired site was sutured with the help of chromatic gut thread.The patient's pain swelling will be measured twice a day immediately before surgery and the day of first thired Seventh and fifteenth after taking the gel,.
Settings and conduct
112 patients who have the approval of the diagnosis department and have referred to Zahedan School of Dentistry, Department of Surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
1. Has a wisdom tooth in the lower jaw with the degree of Secrecy level A and B and class I and II (based on Pell & Gregory classification)
2. Age between 18 and 50 years
Output Criteria:
1. Any systemic disease
2. Patients whom surgery has been performed traumatized.
Intervention groups
1. Control group (normal saline)
2. Chlorhexidine gel group
3. Hydrogen peroxide gel group
4. povidone iodine gel group
Main outcome variables
Examination of pain and swelling in the surgical area after the intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200411047022N1
Registration date:2020-04-15, 1399/01/27
Registration timing:prospective
Last update:2020-04-15, 1399/01/27
Update count:0
Registration date
2020-04-15, 1399/01/27
Registrant information
Name
Sina Hakimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3344 1814
Email address
sinahakimi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of chlorhexidine gel , hydrogen peroxide gel and povidone iodine gel effects on the symptoms of dental socket (pain and swelling) following the wisdom mandibular teeth surgery.
Public title
Comparison of chlorhexidine gel , hydrogen peroxide gel and povidone iodine gel effects on the symptoms of dental socket (pain and swelling) following the wisdom mandibular teeth surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
It has a wisdom tooth in the mandible with a degree of secrecy of levels A and B and classes I and II (based on the Pell & Gregory classification).
Age between 18 and 50 years
Conscious consent to participate in the study
It has commuting and follow-up facilities after intervention
Exclusion criteria:
Any systemic disease
Patients who experience severe pain or abscesses after surgery and are unable to attend the follow-up session.
Patients whom surgery has been performed traumatized
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided to four groups with 28 merber.control group (normal saline user), chlorine hexidine gel consumer group, povidone iodine gel consumer group, and hydrogen peroxide gel consumer group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participant will not be informed of the type of substance used after wisdom tooth surgery
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Dr Hesabi Sq
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2020-02-02, 1398/11/13
Ethics committee reference number
IR.ZAUMS.REC.1398.444
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
G50.1
ICD-10 code description
Atypical facial pain
Primary outcomes
1
Description
The amount of pain
Timepoint
Right before surgery,One day, three days, seven days, fifteen days after taking the gel will be done twice a day.
Method of measurement
The patient's pain measurement will be on Visual analog scale (VAS)
2
Description
Amount of swelling
Timepoint
Right before surgery,One day, three days, seven days, fifteen days after taking the gel will be done twice a day.
Method of measurement
The linear distance between the lingual surface of the first molar mandibular and the tangent to the skin of the cheek is measured using a caliper.
Secondary outcomes
empty
Intervention groups
1
Description
Control group: It is Normal saline and patients in the control group are asked to rinse their mouth twice a day for 15 days after surgery with the normal saline.
Category
Treatment - Drugs
2
Description
First intervention group:The chlorhexidine gel is from the Morvabon brand, which is applied to the area after surgery.
Category
Treatment - Drugs
3
Description
Second intervention group:The Povidone iodon gel is from the Behvazan brand, which is applied to the area after surgery.
Category
Treatment - Drugs
4
Description
Third intervention group:The Hydrogen proxide gel is from the Mehradco brand, which is applied to the area after surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan Dentistry School
Full name of responsible person
Dr Sina Hakimi
Street address
Azadegan East Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3344 1824
Email
sinahakimi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Noor Mohammad Bakhshani
Street address
Dr.Hesabi Sq
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5796
Email
zaums.research@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
40
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
Zahedan University of Medical Sciences
Full name of responsible person
Sina Hakimi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
East Azadegan Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3344 1824
Email
sinahakimi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Sina Hakimi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
East Azadegan Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3344 1824
Email
sinahakimi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Sina Hakimi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
East Azadegan Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3344 1824
Email
sinahakimi@yahoo.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