(1) Objective: This study will conduct to investigate the effect of Gelatamp on pain and gingival bleeding after extraction of teeth. (2) Design: This study is a single center double blind randomized controlled clinical trial. (3) Setting and conduct: This study will conduct in Dental clinic of Qom School of Dentistry. After tooth extraction surgery will use Gelatamp dressing for eligible patients and compare with routine dressing with sterile gauze. (4) Participants including major eligibility criteria: This clinical trial will carry out on 71 patients of both sex, aged 20-45 years who refer for extraction of their two teeth in same location in maxillary or mandibular gingiva. (5) Intervention: After teeth extraction randomly the Geltamp will use in one site and sterile gauze in the other site for dressing. (6) Main outcome measures: Active bleeding will monitor every five minutes until cessation of bleeding and one hour after that. Also pain will measure every six hour for 48 hour.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015113025303N1
Registration date:2015-12-30, 1394/10/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-30, 1394/10/09
Registrant information
Name
Pooya Piri
Name of organization / entity
Qom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8836 8065
Email address
dr_pooyapiri@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Qom University of Medical Sciences
Expected recruitment start date
2015-12-06, 1394/09/15
Expected recruitment end date
2016-01-21, 1394/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Gelatamp effectivness on pain and bleeding after teeth extraction
Public title
The effect of Geltamp on teeth extraction complications
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age between 20-45 years; No sensitivity to silver; Not using corticosteroid; antibiotic and anticoagulant within the past month; Not having clotting disorder; No acute or uncontrolled infection at the surgery site; No malignancy at the surgery site; No history of exposure of surgery site to radiation; Not using contraceptive drug over the past month; Not smoking; Not having hypertension, diabetes, thyroid disorder and blood disorder.
Exclusion criteria: No readmission for second tooth extraction; Failure to complete postoperative; Using of out of prescription drugs; Discontinuation of participation in the study; Developing a systemic disease.
Age
From 20 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
71
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, random allocation between the two groups will be done by using a random numbers table.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qom University of Medical Sciences
Street address
No 83, Alley No 4, Alley No 1/1, Safashahr, Qom
City
Qom
Postal code
Approval date
2015-11-11, 1394/08/20
Ethics committee reference number
IR.MUQ.REC.1394.126
Health conditions studied
1
Description of health condition studied
Bleeding
ICD-10 code
R58
ICD-10 code description
Haemorrhage NOS
2
Description of health condition studied
Pain
ICD-10 code
R52
ICD-10 code description
Acute pain
Primary outcomes
1
Description
Bleeding
Timepoint
Every Five Minutes until Stop of Bleeding
Method of measurement
Minute by Timer
Secondary outcomes
1
Description
Pain
Timepoint
Every Six Hour for 48 Hour
Method of measurement
Visual Analog Scale
Intervention groups
1
Description
Intervention group: Using of one Geltamp in dental socket after tooth extraction Gelatamp is made of 95% foam gelatin sponge and 5% finely dispersed colloidal silver. In this study will use Gelatamp manufactured by Coltene Company in Germany
Category
Prevention
2
Description
Control group: Using of routine dressing with sterile gauze after tooth extraction
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shcool of Dentistry Dental Clinic
Full name of responsible person
Street address
Shahid Lvasani Street, School of Dentistry, Educational Complex of Qom University of Medical Sciences, Qom
City
Qom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Qom University of Medical Sciences
Full name of responsible person
Mohammad Hoessein Abdolmohamdi
Street address
No 83, Alley No 4, Alley No 1/1, Safashahr, Qom
City
Qom
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Qom 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
Qom University of Medical Sciences
Full name of responsible person
Pooya Piri
Position
Dentist
Other areas of specialty/work
Street address
Shahid Lvasani Street, School of Dentistry, Educational Complex of Qom University of Medical Sciences, Qom, Iran.
City
Qom
Postal code
Phone
+98 25 3770 3738
Fax
Email
dr_pooyapiri@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Pooya Piri
Position
Dentist
Other areas of specialty/work
Street address
Shahid Lvasani Street, School of Dentistry, Educational Complex of Qom University of Medical Sciences, Qom, Iran
City
Qom
Postal code
Phone
+98 25 3770 3738
Fax
+98 25 3770 3738
Email
dr_pooyapiri@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 25 3770 3738
Fax
+98 25 3770 3738
Email
dr_pooyapiri@yaoho.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)