Comparison between the effect of CHX 0.2% gel and Ozone gel on preventing dry socket after mandibular third molar surgery.(clinical trial, randomized, double blind)
The aim of this study was to compare the effect of two antibacterial gels, chlorhexidine 0.2% and ozone gel on prevention of dry socket and pain reduction after tooth extraction. Samples of this study were 90 healthy non-smoker men between the ages of 15-60 who referred for mandibular third molar surgery. Three groups of gel were encoded; 30 Syringes of chlorhexidine 0.2% gel, 30 ozone gel syringes and 30 placebo gel syringes (petroleum).
Before surgery, the work process was explained to the patients and written consent was given to them. After each tooth extraction, the area was washed then the encoded gel was placed there and flap was sutured. Patients were followed during the first, third and seventh days after surgery and the area was evaluated for dry socket. At the same time, patients were given a Visual Analogue Scale for measuring pain every day.Finally, the three group datas were compared together.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017082735916N1
Registration date:2017-09-28, 1396/07/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-28, 1396/07/06
Registrant information
Name
Parisa Kohani
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3366 4931
Email address
p.kohani@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
researchers paid the price themselves.
patients paid the cost of surgery.
Expected recruitment start date
2016-08-21, 1395/05/31
Expected recruitment end date
2017-10-08, 1396/07/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the effect of CHX 0.2% gel and Ozone gel on preventing dry socket after mandibular third molar surgery.(clinical trial, randomized, double blind)
Public title
Comparison between the effect of two antibacterial gels on reducing the incidence of dry socket after wisdom teeth surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: man 15-60 years old; completely healthy in terms of systemic conditions (ASA I); at least one mandibular third molar with moderate difficulty; able to filling VAS questionnaire.
exclusion criteria: History of smoking; Taking systemic antibiotics or taking antibiotics over the last 24 hours; The length of the surgical time is more than thirty minutes; Having any history of allergies; History of gastric ulcer or any digestive problem; Not attending follow-up meetings. Use of any other drugs as post-surgical medication; Mental inability to give informed consent.
Age
From 15 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qazvin University of Medical Sciences
Street address
Iran, Qazvin, Bahonar Boulvard, Qazvin University of Medical Sciences
City
Qazvin
Postal code
Approval date
2017-05-13, 1396/02/23
Ethics committee reference number
IR.QUMS.REC.1396.92
Health conditions studied
1
Description of health condition studied
Dry Socket
ICD-10 code
K10.3
ICD-10 code description
Primary outcomes
1
Description
Reducing the prevalevce of dry socket
Timepoint
third day after surgery (follow up)
Method of measurement
postoperative pain in and around the extraction site, which increases in severity at any time between 1 and 3 days after the extraction accompanied by a partially or totally disintegrated blood clot within the alveolar socket with or without halitosis. It has been identified with the scale of Has / has not happened.
2
Description
decreasing the Severity of pain
Timepoint
from 1st to 7th days after surgery
Method of measurement
according to the VAS questionare
Secondary outcomes
1
Description
any side effects after using each gels.
Timepoint
during the first week after surgery
Method of measurement
patients had researcher's phone number to call if they had any problems or questions.
Intervention groups
1
Description
Intevention group
Ozone Gel(O3LIFE,India).
used after surgery and irrigation of socket, up to filling the socket.
Category
Prevention
2
Description
Intevention group
0.2% Chlorhexidine gel (Periokin, Barcelona, Spain).
used after surgery and irrigation of socket, up to filling the socket.
Category
Prevention
3
Description
control group
vaseline(Petroleum Gel)(Sepidaj co, Iran)
used after surgery and irrigation of socket, up to filling the socket.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Qazvin University of Medical Sciences, Dental School
Full name of responsible person
Parisa Kohani
Street address
Qazvin, Bahonar Boulvar,Qazvin University of Medical Sciences, Dental School
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Parisa Kohani
Street address
Qazvin,Bahonar Boulvard,Qazvin University of Medical Sciences.
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Parisa Kohani
Position
Dentistry Student.
Other areas of specialty/work
Street address
Qazvin, daneshgah street,Alley 33, No. 88, Unit 6.
City
Qazvin
Postal code
Phone
+98 28 3366 4931
Fax
Email
parisa.kohani@gmail.com p.kohani@qums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Farshid Raayati
Position
Oral and Maxillofacial Surgen
Other areas of specialty/work
Street address
Qazvin, Shahid Bahonar Blvd, Qazvin University of Medical Sciences, Faculty of Dentistry
City
Qazvin
Postal code
59811 - 34157
Phone
+98 28333530613
Fax
Email
frayati@qums.ac.ir farshidrayati@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Parisa Kohani
Position
Dentistry student.
Other areas of specialty/work
Street address
Qazvin, Daneshgah St, 33th Alley, No 88
City
Qazvin
Postal code
Phone
+98 28 3366 4931
Fax
Email
p.kohani@qums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)