Protocol summary

Study aim
Determination of the effect of Calcium Alginate dressing on bleeding and complications after tooth extraction in patients referred to Oral and maxillofacial surgery department of dental faculty, Islamic Azad University, Tehran, 1395-96
Design
This clinical trial,split mouth study will be done on 30 patients and 60 samples,referred to Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Tehran, Iran, Which will have an indication of simple bilateral tooth extraction in a one jaw,and do not have exclusion criteria(such as:complexity during tooth extraction,need to suturing and systemic disease).Two socket in each jaw are randomly divided into two groups of control and case group.
Settings and conduct
This study will be done on, 20-60 years patients that referred to department of oral and maxillofacial surgery, faculty of dentistry, Tehran, Iran, Which will have an indication of simple bilateral tooth extraction in a one jaw.Each tooth socket will divided randomly into case and control groups.In the control group, conventional gas and in the case group Calcium Alginate dressing will be placed. Then, both groups will be evaluated from the amount of bleeding and other complications after extraction of the tooth in one day, three days and seven days after the operation. In this study blindness will not be performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria; Indication of simple bilateral tooth extraction in one jaw Exclusion criteria; patients with Systemic Diseases; Patients aged less than 20 and over 60 years; Teeth that require flap surgery to remove; Need to use sutures at the treatment site; Things that delay the tissue healing, including: excessive trauma during teeth removal; History of allergy to the drugs used in the study;Absence of referral for re-examination by the patient
Intervention groups
The control group;The tooth Socket that will be dressed by conventional gas. The case group; The tooth Socket that will be dressed by Calcium Algnate.
Main outcome variables
In this study, variables: bleeding, one hour and 24 hours after operation and healing, pain and dry socket on the third and seventh day after surgery will be assesed.it is expected that;Using the dressing of calcium alginate, the amount of bleeding, dry socket and post operative pain will decreases; and tissue healing will increases.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171216037893N1
Registration date: 2018-01-29, 1396/11/09
Registration timing: registered_while_recruiting

Last update: 2018-01-29, 1396/11/09
Update count: 0
Registration date
2018-01-29, 1396/11/09
Registrant information
Name
Hamidreza Mahaseni aghdam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2240 6440
Email address
h_mahaseni@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Calcium Alginate dressing on bleeding and complications after tooth extraction socket
Public title
The effect of Calcium Alginate dressing on bleeding and complications after tooth extraction socket
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Indication of simple bilateral tooth extraction in one jaw
Exclusion criteria:
patients with systemic diseases Patients aged less than 20 and over 60 years Teeth that require flap surgery to remove Need to use sutures at the treatment site Things that delay the tissue healing, including: excessive trauma during teeth removal History of allergy to the drugs used in the study Absence of referral for re-examination by the patient
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
More than 1 sample in each individual
Number of samples in each individual: 2
A dental socket after removing it on one side of the jaw
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Random Sampling individually with using random numbers
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study is split mouth

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University of Medical Sciences
Street address
No.4,Thens Neyestan,Pasdaran street
City
Tehran
Province
Tehran
Postal code
19486
Approval date
2017-09-24, 1396/07/02
Ethics committee reference number
IR.IAU.DENTAL.REC.1396/23

Health conditions studied

1

Description of health condition studied
Indication of simple bilateral tooth extraction in one jaw
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Bleeding ;
Timepoint
one hour and 24 hours after surgery
Method of measurement
placement of the gas on tooth socketٍ every 15 seconds until the stain of blood do not get bigger

2

Description
Dry socket
Timepoint
the third and seventh day after surgery
Method of measurement
BLUM scale

3

Description
pain
Timepoint
the third and seventh day after surgery
Method of measurement
VAS scale

4

Description
Healing
Timepoint
the third and seventh day after surgery
Method of measurement
Healing scale

Secondary outcomes

empty

Intervention groups

1

Description
" Case group"; The tooth Socket that will be dressed by Calcium Algnate.
Category
Treatment - Devices

2

Description
"Control group": The tooth Socket that will be dressed by conventional gas.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Dentistry, Azad University of Medical Sciences, Tehran, Iran
Full name of responsible person
Dr Hamid Reza Mahaseni Aghdam
Street address
Pasdaran street
City
Tehran
Province
Tehran
Postal code
19486
Phone
+98 21 2564 5703
Fax
+98 21 2564 5703
Email
h_mahaseni@dentaliau.ac.ir
Web page address
http://www.dentaliau.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Personal
Full name of responsible person
Dr Hamid Reza Mahaseni Aghdam
Street address
No.4,Thens Neyastan.Pasdaran Street ,Tehran
City
Tehran
Province
Tehran
Postal code
19585/175
Phone
+98 21 2564 5703
Fax
Email
H_mahaseni@dentaliau.ac.ir
Web page address
http://www.dentaliau.ac.ir/
Grant name
Nothing
Grant code / Reference number
ندارد
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Personal
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
Islamic Azad University
Full name of responsible person
Hamid Reza Mahaseni Aghdam
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No.4,Thens Neyestan,Pasdaran Street
City
Tehran
Province
Tehran
Postal code
19486
Phone
+98 21 2564 5703
Fax
Email
H_mahaseni@dentaliau.ac.ir
Web page address
http://www.dentaliau.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Hamidreza Mahaseni Aghdam
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No.4, Thens Neyestan, Pasdaran Street,Tehran
City
Tehran
Province
Tehran
Postal code
19585/175
Phone
+98 212564570
Email
h_mahaseni@dentaliau.ac.ir
Web page address
http://www.dentaliau.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Hamidreza Mahasen Aghdam
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No.4,Thens Neyestan street, Pasdaran street,Teran
City
Tehran
Province
Tehran
Postal code
19585/175
Phone
+98 212564570
Email
h_mahaseni@dentaliau.ac.ir
Web page address
http://www.dentaliau.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
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