Evaluation of anti-pain effect of the absorbable scaffold containing slow releasing lidocaine in alveolar socket of surgical extracted impacted third molars
This study is a clinical trials. This study was designed to evaluate the effects of anesthetics of this substance and the control of pain and the duration of its effectiveness. The population of this study is all individuals who refer to Tabriz University of Medical Sciences for the treatment of impacted third molar teeth. Examples of this study are two groups that are used in one group of lidocaine as topical anesthetic and in the other group of placebo.Therefore, according to the studies and the corresponding formula, 72 people will be selected.Twenty-four individuals randomly selected for each group of lidocaine in the form of a slow-releasing scaffold, and in the other group with the same title, but without being aware of themselves and the therapist, are used as scaffolds (placebo), and in the other group, these scaffolds are not used, but the patient receives routine treatments (acetagel ) after surgery and will only be reported as the control group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201705063018N3
Registration date:2017-11-08, 1396/08/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-08, 1396/08/17
Registrant information
Name
Ali Hossein Mesgarzadeh
Name of organization / entity
Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1333 6813
Email address
mesgarzadeha@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2014-12-31, 1393/10/10
Expected recruitment end date
2017-11-21, 1396/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of anti-pain effect of the absorbable scaffold containing slow releasing lidocaine in alveolar socket of surgical extracted impacted third molars
Public title
Using of the absorbable scaffold containing slow releasing lidocaine in surgery area.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: third molars teeth surgery in patients with bone impaction.
Exclusion criteria: for patients with sinoatrial bluck heart disease and those who have adams stokes syndrom and wolff parkinson white syndrom; those taking the following drugs: quinidine, disopiramid, procainamide Amiodarone hydrochloride and are treated with caution in these patients: elderly patients; porphyrya; hepatic failure; bradycardia.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
N/A
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
Tabriz Univercity of Medical Sciences
Street address
East Azerbaijan Province, Tabriz, Univesity Main St
City
Tabriz
Postal code
Approval date
2017-02-06, 1395/11/18
Ethics committee reference number
IR.TBZMED.REC.1395.1181
Health conditions studied
1
Description of health condition studied
Impacted teeth
ICD-10 code
K01.1
ICD-10 code description
An impacted tooth is a tooth that has failed to erupt because of obstruction by another tooth.
Primary outcomes
1
Description
Determination and comparison of pain levels in the control and placebo groups of slow-releasing lidocain as scaffolds in the surgical area of the impacted wisdom teeth
Timepoint
Immediately after surgical intervention
Method of measurement
visual analog scale way
Secondary outcomes
1
Description
Determination and comparison of the onset time of pain in the control and placebo groups of the slow-releasing lidocaine as a scaffold in the surgical area of the impacted wisdom teeth.
Timepoint
Immediately after surgical intervention
Method of measurement
In the checklist, the time of the onset of pain and the duration of the pain are asked verbally from the patient and within a few hours the patient's response will be recorded.
Intervention groups
1
Description
In the 24 patients of the intervention group, will used absorbable scaffold of lidocaine in the surgery area.
Category
Treatment - Surgery
2
Description
24 other patients of the placebo group will be usining empty scaffolds without lidocaine.
Category
Placebo
3
Description
In 24 of the control group, post-operative routine analgesic treatments (staggel 500 mg and 400 mg jelly) are used and no other therapeutic intervention will be taken.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry
Full name of responsible person
Street address
Tabriz University of Medical Sciences
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Vice-chancellor Tabriz Univercity of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Rashidi
Street address
East Azerbaijan Province, Tabriz, Univesity Main St.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice-chancellor Tabriz Univercity 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
Tabriz University of Medical Sciences
Full name of responsible person
Nadiyeh Abdolahyazar
Position
Doctorate of dentistry
Other areas of specialty/work
Street address
West Azarbaijan, Omiyah, Sheikh Tapeh Street, 22nd Street, Building 21
City
Oromiyeh
Postal code
Phone
+98 44 4422 7533
Fax
Email
n.abdolahyazar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Ali Hossein Mesgarzadeh
Position
Associate Professor in Oral and Maxillofacial Surgery Department
Other areas of specialty/work
Street address
East Azerbaijan Province, Tabriz, Univesity Main St.
City
Tabriz
Postal code
Phone
+98 41 3335 5965
Fax
Email
mesgarcu@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Ali Hossein Mesgarzadeh
Position
Associate Professor in Oral and Maxillofacial Surgery Department
Other areas of specialty/work
Street address
East Azerbaijan Province, Tabriz, Univesity Main St
City
Tabriz
Postal code
Phone
+98 41 3335 5965
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)